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Treinamento com equipamento eletromecânico para caminhada após derrame

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Introdução

Os dispositivos eletromecânicos e robóticos de treino para marcha assistida são usados na reabilitação e podem ajudar a melhorar a marcha após derrame. Esta é uma atualização de uma revisão Cochrane publicada pela primeira vez em 2007.

Objetivos

Investigar os efeitos dos dispositivos eletromecânicos e automatizados de treinamento para melhorar a marcha após derrame.

Métodos de busca

Fizemos buscas nas seguintes bases de dados: Cochrane Stroke Group Trials Register (última busca em 9 de agosto 2016), Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2016, Issue 8), MEDLINE Ovid (1950 a 15 de agosto 2016), Embase (1980 a 15 de agosto 2016), CINAHL (1982 a 15 de agosto 2016), AMED (1985 a 15 de agosto 2016), Web of Science (1899 a 16 agosto 2016), SPORTDiscus (1949 a 15 setembro 2012), e Physiotherapy Evidence Database (PEDro) (pesquisada em 16 agosto 2016). Também fizemos buscas em duas bases de dados de engenharia: COMPENDEX (1972 a 16 de novembro 2012) e Inspec (1969 a 26 de agosto 2016). Fizemos buscas manuais em anais de conferências relevantes. Também fizemos buscas em plataformas de registros de ensaios clínicos, verificamos as listas de referências dos estudos, e contatamos autores para identificar outros estudos publicados, não publicados, e em andamento.

Critério de seleção

Incluímos todos os ensaios clínicos controlados randomizados (ECRs), e os ensaios clínicos do tipo cross‐over, envolvendo pessoas maiores de 18 anos diagnosticadas com AVC de qualquer gravidade, em qualquer estágio, ou qualquer ambiente. Os estudos deveriam comparar o treinamento da marcha com dispositivos eletromecânicos e robóticos versus cuidados habituais.

Coleta dos dados e análises

Dois autores da revisão, trabalhando de forma independente, selecionaram os estudos, extraíram os dados, e avaliaram a qualidade metodológica e os riscos de viés. O desfecho primário foi a proporção de participantes capazes de caminhar sem ajuda (marcha independente) no seguimento.

Principais resultados

Esta versão atualizada da revisão inclui 36 estudos envolvendo 1472 participantes. O treino da marcha assistida por aparato eletromecânico em combinação com a fisioterapia aumentou a probabilidade dos participantes se tornarem independentes para caminhar: razão de chances (OR) na metanálise de efeitos aleatórios 1,94, intervalo de confiança (IC) de 95% 1,39 a 2,71, P < 0,001, I² = 8%, evidência de qualidade moderada. Porém, a intervenção não aumentou significativamente a velocidade da caminhada (diferença média‐ MD 0,04 m/s, IC 95% 0,00 a 0,09, P = 0,08, I² = 65%, evidência de baixa qualidade) ou a capacidade de caminhada (MD 5,84 metros caminhados em 6 minutos, IC 95% ‐16.73 a 28.40, P = 0.61, I² = 53%, evidência de qualidade muito baixa). Os resultados devem ser interpretados com cautela, pois 1) alguns estudos investigaram pessoas que eram independentes para caminhar desde o início do estudo; 2) houve variações entre os estudos quanto aos dispositivos utilizados, duração e frequência do tratamento, e 3) alguns estudos incluíram dispositivos com estimulação elétrica funcional. Nossas análises de subgrupos sugerem que os pacientes na fase aguda poderiam se beneficiar, porém os pacientes na fase crônica podem não se beneficiar desse tipo de treinamento eletromecânico de marcha assistida. A análise post hoc mostrou que as pessoas que não deambulam no momento da intervenção podem se beneficiar, mas as pessoas que deambulam podem não se beneficiar desse tipo de treinamento. A análise post hoc não mostrou diferenças entre os tipos de dispositivos utilizados sobre a capacidade de caminhar. Porém houve diferenças significativas entre os dispositivos sobre a velocidade da marcha.

Conclusão dos autores

Os pacientes que tiveram um derrame e que recebem treinamento eletromecânico assistido para marcha mais fisioterapia têm maior probabilidade de conseguir caminhar independentemente do que aqueles que recebem treinamento para caminhar sem esses dispositivos. É necessário tratar sete pacientes para prevenir um caso de dependência para caminhar. Os pacientes nos três primeiros meses após o AVC, e aqueles que não são capazes de andar, parecem ser os que mais se beneficiam com este tipo de intervenção. Ainda não está claro qual é o efeito do tipo de dispositivo. É necessário fazer mais pesquisas nessa área. Os novos estudos devem ser grandes ensaios clínicos pragmáticos de fase III para avaliar qual são a frequência e a duração mais efetivas do treinamento eletromecânico de marcha assistida. Esses novos estudos devem também avaliar a duração dos benefícios dessa intervenção.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Resumo para leigos

Dispositivos automatizados de treino para melhorar a marcha de pessoas que tiveram um derrame

Pergunta da revisão

O treinamento assistido com máquinas e equipamentos robotizados melhora a marcha de pessoas que tiveram um derrame?

Introdução

Muitas pessoas que tiveram derrame têm dificuldades para andar. Portanto, a melhora da marcha é um dos principais objetivos da reabilitação. Os dispositivos automatizados de treino ajudam as pessoas a voltarem a andar.

Data da busca

A revisão está atualizada até agosto de 2016. Isso significa que ela incluiu todos os estudos publicados até essa data.

Características do estudo

Incluímos 36 estudos envolvendo um total de 1472 pessoas maiores de 18 anos que tiveram um acidente vascular cerebral (AVC) isquêmico agudo, pós‐agudo ou crônico, ou um AVC hemorrágico. A idade média das pessoas incluídas nos estudos variou de 48 a 76 anos. A maior parte dos estudos envolveu pacientes internados.

Principais resultados

Existe evidência de qualidade moderada de que o treinamento da marcha assistido por dispositivo eletromecânico combinado à fisioterapia, quando comparado à fisioterapia isolada, pode melhorar as chances de pessoas que tiveram um AVC voltarem a andar sem ajuda.

É necessário tratar sete pessoas com dispositivos eletromecânicos e assistidos por robô para evitar um caso de dependência para caminhar.

Os pacientes nos três primeiros meses após o AVC, e aqueles que não são capazes de andar parecem ser os que mais se beneficiam com este tipo de intervenção. A importância do tipo de dispositivo ainda não está clara. Novos estudos devem investigar qual são a frequência ou a duração do treino mais eficazes, e também qual é a duração desse benefício. Também não está claro como esses dispositivos devem ser usados na rotina de reabilitação.

Qualidade da evidência

A qualidade da evidência foi moderada para o uso dos dispositivos eletromecânicos automatizados e assistidos por robô para melhorar a marcha após o derrame. A qualidade da evidência foi baixa para velocidade da marcha, eventos adversos, e abandono do tratamento. A qualidade da evidência foi muito baixa para capacidade de caminhar.

Authors' conclusions

Implications for practice

This systematic review provides moderate‐quality evidence that the use of electromechanical‐assisted gait‐training devices in combination with physiotherapy increases the chance of regaining independent walking ability in people after stroke. These results could be interpreted as preventing one participant from remaining dependent in walking after stroke for every seven treated. However, this apparent benefit for patients is not supported by our secondary outcomes. Gait‐training devices were associated with neither improvements in walking velocity nor walking capacity (low‐ to very low‐quality evidence). It appears that the greatest benefits with regard to independence in walking and walking speed were achieved in participants who were non‐ambulatory at the start of the study and in those for whom the intervention was applied early poststroke.

Implications for research

There is still a need for well‐designed, large‐scale, multicentre studies to evaluate the benefits and harms of electromechanical‐assisted gait training for walking after stroke, including only non‐ambulatory people in the very early stages after stroke. Comparisons between different devices are also currently lacking. Future research should include estimates of the costs (or savings) associated with electromechanical gait training. Further analyses should investigate whether non‐ambulatory or ambulatory people benefit most, and trials should include outcome measures in the activities of daily living and quality of life domains. In future updates of this review we will consider investigating the effects of different control interventions using subgroup analysis. Additionally, in the next update we will compare the effects of different duration and intensity of treatment (e.g. less than versus more than four weeks; five days per week versus less than five days).

Summary of findings

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Summary of findings for the main comparison. Electromechanical‐ and robotic‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke

Electromechanical‐ and robotic‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke

Patient or population: walking after stroke
Setting: inpatient and outpatient setting
Intervention: electromechanical‐ and robotic‐assisted gait training plus physiotherapy
Comparison: physiotherapy (or usual care)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with physiotherapy (or usual care)

Risk with electromechanical‐ and robotic‐assisted gait training plus physiotherapy

Independent walking at the end of intervention phase, all electromechanical devices used
Assessed with FAC

Study population

OR 1.94
(1.39 to 2.71)

1472
(36 RCTs)

⊕⊕⊕⊝
MODERATE 1

457 per 1000

615 per 1000
(530 to 693)

Recovery of independent walking at follow‐up after study end
Assessed with FAC

Study population

OR 1.93
(0.72 to 5.13)

496
(6 RCTs)

⊕⊕⊕⊝
MODERATE 1

551 per 1000

703 per 1000
(469 to 863)

Walking velocity (metres per second) at the end of intervention phase
Assessed with timed measures of gait
Scale: 0 to infinity

The mean walking velocity (metres per second) at the end of intervention phase was 0.

MD 0.04 higher
(0 to 0.09 higher)

985
(24 RCTs)

⊕⊕⊝⊝
LOW 1 2

Walking velocity (metres per second) at follow‐up
Assessed with timed measures of gait
Scale: 0 to infinity

The mean walking velocity (metres per second) at follow‐up was 0.

MD 0.07 higher
(0.05 lower to 0.19 higher)

578
(9 RCTs)

⊕⊕⊕⊝
MODERATE 1

Walking capacity (metres walked in 6 minutes) at the end of intervention phase
Assessed with timed measures of gait
Scale: 0 to infinity

The mean walking capacity (metres walked in 6 minutes) at the end of intervention phase was 0.

MD 5.84 higher
(16.73 lower to 28.40 higher)

594
(12 RCTs)

⊕⊝⊝⊝
VERY LOW 1 3 4

Walking capacity (metres walked in 6 minutes) at follow‐up

The mean walking capacity (metres walked in 6 minutes) at follow‐up was 0.

MD 0.82 lower
(32.17 lower to 30.53 higher)

463
(7 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 4

Acceptability of electromechanical‐assisted gait‐training devices during intervention phase
Assessed with number of dropouts

Study population

OR 0.67
(0.43 to 1.05)

1472
(36 RCTs)

⊕⊕⊝⊝
LOW 1 5

131 per 1000

92 per 1000
(61 to 136)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; FAC: Functional Ambulation Category; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded due to several ratings of 'unclear' and 'high' risk of bias.
2Downgraded due to statistical heterogeneity and no overlap of several confidence intervals.
3Downgraded because the 95% confidence interval includes no effect and the upper confidence limit crosses the minimal important difference.
4Downgraded due to funnel plot asymmetry.
5Downgraded because the total number of events (157) is less than 300 (a threshold rule‐of‐thumb value).

Background

Description of the condition

A stroke is a sudden, non‐convulsive loss of neurological function due to an ischaemic or haemorrhagic intracranial vascular event (WHO 2006). In general, cerebrovascular accidents are classified by anatomic location in the brain, vascular distribution, aetiology, age of the affected individual, and haemorrhagic versus non‐haemorrhagic nature (Adams 1993). Stroke is a leading cause of death and serious long‐term disability in adults. Three months after stroke, 20% of people remain wheelchair bound, and approximately 70% walk at a reduced velocity and capacity (Jorgensen 1995). Restoration of walking ability and gait rehabilitation are therefore highly relevant for people who are unable to walk independently after stroke (Bohannon 1991), as well as for their relatives. To restore gait, modern concepts of rehabilitation favour a repetitive task‐specific approach (Carr 2003; French 2007). In recent years it has also been shown that higher intensities of walking practice (resulting in more repetitions trained) resulted in better outcomes for people after stroke (Kwakkel 1999; Van Peppen 2004).

Description of the intervention

As an adjunct to overground gait training (States 2009), in recent years treadmill training has been introduced for the rehabilitation of people after stroke (Mehrholz 2014). Treadmill training with and without partial body weight support enables the repetitive practice of complex gait cycles for these people. However, one disadvantage of treadmill training might be the effort required by therapists to set the paretic limbs and to control weight shift, thereby possibly limiting the intensity of therapy, especially in more severely disabled people. Automated electromechanical gait machines were developed to reduce dependence on therapists. They consist of either a robot‐driven exoskeleton orthosis or an electromechanical solution, with two driven foot plates simulating the phases of gait (Colombo 2000; Hesse 1999).

One example of automated electromechanical gait rehabilitation is the Lokomat (Colombo 2000). A robotic gait orthosis combined with a harness‐supported body weight system is used together with a treadmill. The main difference from treadmill training is that the patient's legs are guided by the robotic device according to a preprogrammed gait pattern. A computer‐controlled robotic gait orthosis guides the patient, and the process of gait training is automated.

A second example is the Gait Trainer GT I, which is based on a double crank and rocker gear system (Hesse 1999). In contrast to a treadmill, the electromechanical Gait Trainer GT I consists of two foot plates positioned on two bars, two rockers, and two cranks, which provide the propulsion. The harness‐secured patient is positioned on the foot plates, which symmetrically simulate the stance and swing phases of walking (Hesse 1999). A servo‐controlled motor guides the patient during walking exercise. Vertical and horizontal movements of the trunk are controlled in a phase‐dependent manner. Again, the main difference from treadmill training is that the process of gait training is automated and is supported by an electromechanical solution.

Other similar electromechanical devices that have been developed in recent years include the Haptic Walker (Schmidt 2005), the Anklebot (MIT 2005), and the LOPES (Lower Extremity Powered Exoskeleton) (Veneman 2005). More recently, new so‐called powered mobile solutions, Buesing 2015, Stein 2014, Watanabe 2014, and ankle robots, Forrester 2014, Waldman 2013, to improve walking have been described in the literature.

How the intervention might work

Electromechanical devices (such as those previously described) can be used to give non‐ambulatory patients intensive practice (in terms of high repetitions) of complex gait cycles. The advantage of these electromechanical devices compared with treadmill training with partial body weight support may be the reduced effort required of therapists, as they no longer need to set the paretic limbs or assist trunk movements (Hesse 2003).

Why it is important to do this review

Scientific evidence for the benefits of the above‐mentioned technologies may have changed since our Cochrane Review was first published in 2007 (Mehrholz 2007), and so an update of the review was required to justify the large equipment and human resource costs needed to implement electromechanical‐assisted gait devices, as well as to confirm the safety and acceptance of this method of training. The aim of this review was therefore to provide an update of the best available evidence about the above‐mentioned approach.

Objectives

To investigate the effects of automated electromechanical‐ and robotic‐assisted gait‐training devices for improving walking after stroke.

Methods

Criteria for considering studies for this review

Types of studies

We searched for all randomised controlled trials and randomised controlled cross‐over trials for inclusion in this review. If we included randomised controlled cross‐over trials, we planned to analyse only the first period as a parallel‐group trial.

Types of participants

We included studies with participants of any gender over 18 years of age after stroke, using the World Health Organization (WHO) definition of stroke or a clinical definition of stroke if the WHO definition was not specifically stated (WHO 2006).

Types of interventions

We included all trials that evaluated electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care) for regaining and improving walking after stroke. We also included automated electromechanical devices that were used in combination with therapies such as functional electrical stimulation applied to the legs during gait training (compared with therapies not using electromechanical devices). We defined an automated electromechanical device as any device with an electromechanical solution designed to assist stepping cycles by supporting body weight and automating the walking therapy process in people after stroke. This category included any mechanical or computerised device designed to improve walking function. We also searched for electromechanical devices such as robots for gait training after stroke (MIT 2005; Schmidt 2005; Veneman 2005).

Electromechanical devices can principally be differentiated into end‐effector and exoskeleton devices. Examples of end‐effector devices are the LokoHelp (Freivogel 2009), the Haptic Walker (Schmidt 2005), and the Gait Trainer GT I (Hesse 1999). The definition of an end‐effector principle is that a patient's feet are placed on foot plates, whose trajectories simulate the stance and swing phases during gait training (Hesse 2010). An example of exoskeleton devices is the Lokomat (Colombo 2000). Such exoskeletons are outfitted with programmable drives or passive elements, which move the knees and hips during the phases of gait (Hesse 2010).

We did not include non‐weight‐bearing interventions such as non‐interactive devices that deliver continuous passive motion only (Nuyens 2002). We excluded trials testing the effectiveness of treadmill training or other approaches such as repetitive task training in physiotherapy or electrical stimulation alone (French 2016; Pollock 2014), to prevent duplication with other Cochrane Reviews and protocols (e.g. Mehrholz 2014).

Types of outcome measures

Primary outcomes

Regaining the ability to walk is a very important goal for people after stroke (Bohannon 1988). We therefore defined the primary outcome as the ability to walk independently. We measured the ability to walk with the Functional Ambulation Category (FAC) (Holden 1984). A FAC score of 4 or 5 indicated independent walking over a 15‐metre surface, irrespective of aids used such as a cane. A FAC score of less than 4 indicates dependency in walking (supervision or assistance, or both must be given in performing walking).

If the included studies did not report FAC scores, we used alternative indicators of independent walking, such as:

  • a score of 3 on the ambulation item of the Barthel Index (Wade 1988); or

  • a score of 6 or 7 for the walking item of the Functional Independence Measure (Hamilton 1994); or

  • a 'yes' response to the item 'walking inside, with an aid if necessary (but with no standby help)' or 'yes' to 'walking on uneven ground' in the Rivermead Mobility Index (Collen 1991).

Secondary outcomes

We defined secondary outcomes as measures of activity limitations. We used walking speed (in metres per second), walking capacity (metres walked in 6 minutes), and the Rivermead Mobility Index score as relevant measures of activity limitations, if stated by the trialists. Additionally, we used death from all causes as a secondary outcome.

Adverse outcomes

We investigated the safety of electromechanical‐assisted gait‐training devices with the incidence of adverse outcomes such as thrombosis, major cardiovascular events, injuries, pain, and any other reported adverse events. To measure the acceptance of electromechanical‐assisted gait‐training devices in walking therapies, we used visual analogue scales or withdrawal from the study for any reason (dropout rates), or both during the study period, depending on data provided by the study authors.

Depending on the above‐stated categories and the availability of variables used in the included trials, we discussed and reached consensus on which outcome measures should be included in the analysis.

Search methods for identification of studies

See the 'Specialized register' section in the Cochrane Stroke Group module. We searched for trials in all languages and arranged for translation of relevant papers published in languages other than English.

Electronic searches

We searched the Cochrane Stroke Group Trials Register (last searched August 2016) and the following electronic bibliographic databases:

  • The Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 8, 2016) (Appendix 1);

  • MEDLINE in Ovid (1950 to 15 August 2016) (Appendix 2);

  • Embase (1980 to 15 August 2016) (Appendix 3);

  • CINAHL (Cumulative Index to Nursing and Allied Health Literature) in EBSCO (1982 to 15 August 2016) (Appendix 4);

  • AMED (Allied and Complementary Medicine Database) (1985 to 15 August 2016) (Appendix 5);

  • Web of Science (Science Citation Index Expanded, Social Sciences Citation Index, Arts and Humanities Citation Index) (1899 to 16 August 2016) (Appendix 6);

  • PEDro (Physiotherapy Evidence Database) (searched 16 August 2016) (Appendix 7);

  • COMPENDEX (1972 to 16 November 2012) (Appendix 8);

  • SPORTDiscus (1949 to 15 September 2012) (Appendix 9); and

  • Inspec (1969 to 26 August 2016) (Appendix 10).

We developed the search strategies with the help of the Cochrane Stroke Group Information Specialist and adapted the MEDLINE search strategy for the other databases.

We identified and searched the following ongoing trials and research registers:

Searching other resources

We also:

  • handsearched the following relevant conference proceedings:

    • World Congress of NeuroRehabilitation (2002, 2006, 2008, 2010, 2012, 2014, and 2016);

    • World Congress of Physical Medicine and Rehabilitation (2001, 2003, 2005, 2007, 2009, 2011, 2013, and 2015);

    • World Congress of Physical Therapy (2003, 2007, 2011, and 2015);

    • Deutsche Gesellschaft für Neurotraumatologie und Klinische Neurorehabilitation (2001 to 2015);

    • Deutsche Gesellschaft für Neurologie (2000 to 2016);

    • Deutsche Gesellschaft für Neurorehabilitation (1999 to 2016); and

    • Asia‐Oceanian Conference of Physical & Rehabilitation Medicine (2008 to 2016).

  • screened reference lists of all relevant articles; and

  • contacted trialists, experts, and researchers in our field of study.

Data collection and analysis

Selection of studies

Two review authors (JM, BE) independently read the titles and abstracts of the identified references and eliminated obviously irrelevant studies. We obtained the full text for the remaining studies. Based on our inclusion criteria (types of studies, participants, aims of interventions, outcome measures), the same two review authors independently ranked these studies as relevant, irrelevant, or possibly relevant. We excluded all trials ranked initially as irrelevant but included all other trials at this stage. We excluded all trials of specific treatment components, such as electrical stimulation as stand‐alone treatment, treadmill training, and continuous passive motion treatment, because these have been the subject of other Cochrane Reviews (e.g. Mehrholz 2014). We resolved any disagreements through discussion between all four review authors. If we required further information to reach consensus, we contacted trialists in an attempt to obtain the missing information. We recorded the selection process in sufficient detail to complete a PRISMA flow diagram, and listed all studies that did not match our inclusion criteria regarding types of studies, participants, and aims of interventions in the Characteristics of excluded studies table.

Data extraction and management

Two review authors (JM, BE) independently extracted trial and outcome data from the selected trials. We established the characteristics of unpublished trials through correspondence with the trial co‐ordinator or principal investigator. If any review author was involved in any of the selected studies, another review author not involved in the study extracted the study information. If there was any doubt as to whether a study should be excluded, we retrieved the full text of the article. In cases of disagreement between the two review authors, a third review author (JK) reviewed the information to decide on inclusion or exclusion of a study. We used checklists to independently record the following details.

  • Methods of generating the randomisation schedule.

  • Method of concealment of allocation.

  • Blinding of assessors.

  • Use of an intention‐to‐treat analysis (all participants initially randomly assigned were included in the analyses as allocated to groups).

  • Adverse events and dropouts for all reasons.

  • Important imbalance in prognostic factors.

  • Participants (country, number of participants, age, gender, type of stroke, time from stroke onset to entry to the study, inclusion and exclusion criteria).

  • Comparison (details of the intervention in treatment and control groups, details of co‐intervention(s) in both groups, duration of treatment).

  • Outcomes and time points of measures (number of participants in each group and outcome, regardless of compliance).

The two review authors checked all of the extracted data for agreement, with a third review author (JK) arbitrating any items for which consensus could not be reached. If necessary, we contacted trialists to request more information, clarification, and missing data.

Assessment of risk of bias in included studies

Two review authors (JM, MP) independently evaluated the methodological quality of the included trials using the Cochrane 'Risk of bias' tool, as described in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).

We checked all methodological quality assessments for agreement between review authors. We resolved disagreements by discussion. If one of the review authors was a co‐author of an included trial, another review author (BE or JK) conducted the methodological quality assessment for this trial in this case.

Measures of treatment effect

We planned to compare electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care) for primary and secondary outcome parameters. We used the effect measures odds ratio (OR) or mean difference (MD) in the meta‐analyses.

Unit of analysis issues

We analysed binary (dichotomous) outcomes with an OR, random‐effects model with 95% confidence intervals (CIs). We analysed continuous outcomes with MDs, using the same outcome scale. We used a random‐effects model for all analyses. We used Cochrane Review Manager 5 software for all statistical comparisons, (RevMan 2014).

Dealing with missing data

In the case of missing outcome data, we attempted to analyse data according to the intention‐to‐treat approach. We contacted the trial co‐ordinator or principal investigator if data were missing.

Assessment of heterogeneity

We used the I² statistic to assess heterogeneity. We used a random‐effects model, regardless of the level of heterogeneity.

Assessment of reporting biases

We inspected funnel plots to assess the risk of publication bias.

Data synthesis

GRADE and 'Summary of findings' table

We created two 'Summary of findings' tables using the following outcomes.

  • Primary outcome measure: Independent walking at the end of intervention phase, all electromechanical devices used. Scale from 0 to infinity.

  • Primary outcome measure: Recovery of independent walking at follow‐up after study end. Scale from 0 to infinity.

  • Primary outcome measure: Walking velocity (metres per second) at the end of intervention phase. Scale from 0 to infinity.

  • Secondary outcome measure: Walking velocity (metres per second) at follow‐up. Scale from 0 to infinity.

  • Secondary outcome measure: Walking capacity (metres walked in 6 minutes) at the end of intervention phase. Scale from 0 to infinity.

  • Secondary outcome measure: Walking capacity (metres walked in 6 minutes) at follow‐up. Scale from 0 to infinity.

  • Secondary outcome measure: Acceptability of electromechanical‐assisted gait‐training devices during intervention phase: number of dropouts.

We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of a body of evidence as it relates to the studies that contribute data to the meta‐analyses for the prespecified outcomes (Atkins 2004). We used methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011b), employing GRADEpro GDT software (GRADEpro GDT). We justified all decisions to down‐ or upgrade the quality of studies using footnotes, and made comments to aid the reader's understanding of the review where necessary.

Subgroup analysis and investigation of heterogeneity

As planned in our protocol (Mehrholz 2006), we performed a formal subgroup analysis following the guidance in the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2011), comparing participants treated in the acute and subacute phases of their stroke (within three months) with participants treated in the chronic phase (longer than three months).

Sensitivity analysis

As planned in our protocol, we performed a sensitivity analysis of methodological quality for each included study.

We carried out the following sensitivity analyses by including only those studies:

  • with an adequate sequence generation process;

  • with adequate concealed allocation;

  • with blinded assessors for the primary outcome; and

  • without incomplete outcome data.

We considered it necessary to do a further sensitivity analysis by removing the largest study, Pohl 2007, because some of the review authors (JM, MP, and CW) were investigators in this large trial. We carried out this sensitivity analysis by including all studies without the largest study (Pohl 2007).

We performed two further (post hoc) sensitivity analyses.

  • Ambulatory status at start of study (including only studies that included an independent walker; including only studies that included dependent and independent walkers; and including only studies that included a dependent walker).

  • Type of device used in trials (including only studies that used end‐effector devices and including only studies that used exoskeleton devices).

Results

Description of studies

See the Characteristics of included studies, Characteristics of excluded studies, and Characteristics of ongoing studies tables.

Results of the search

Figure 1 shows the flow diagram of the selection of studies for this update.


Study flow diagram.

Study flow diagram.

Searches of the electronic databases and trials registers generated 7083 new unique references for screening. After excluding non‐relevant citations, we obtained the full text of 55 new papers, and from these identified and included 13 new trials in the review.

Included studies

We included 36 trials involving a total of 1472 participants (see the Characteristics of included studies, Figure 1, Table 1, and Table 2). All included studies investigated the effects of electromechanical‐ or robotic‐assisted gait‐training devices in improving walking after stroke.

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Table 1. Participant characteristics in studies

Study ID

Experimental:

age, mean (SD)

Control:

age, mean (SD)

Experimental:

time poststroke

Control:

time poststroke

Experimental:

sex

Control:

sex

Experimental:

side paresis

Control:

side paresis

Aschbacher 2006

57 years

65 years

≤ 3 months

≤ 3 months

2 female

4 female

Not stated

Not stated

Bang 2016

54 years

54 years

12 months

13 months

5 male, 4 female

4 male, 5 female

4 right, 5 left

4 right, 5 left

Brincks 2011

61 (median) years

59 (median) years

56 (median) days

21 (median) days

5 male, 2 female

4 male, 2 female

5 right, 2 left

1 right, 5 left

Buesing 2015

60 years

62 years

7 years

5 years

17 male, 8 female

16 male, 9 female

13 right, 12 left

12 right, 13 left

Chang 2012

56 (12) years

60 (12) years

16 (5) days

18 (5) days

13 male, 7 female

10 male, 7 female

6 right, 14 left

6 right, 11 left

Cho 2015

55 (12) years

55 (15) years

15 months

13 months

Not stated

Not stated

6 right, 4 left (4 both)

3 right, 1 left (3 both)

Chua 2016

62 (10) years

61 (11) years

27 (11) days

30 (14) days

35 male, 18 female

40 male, 13 female

24 right, 29 left

21 right, 32 left

Dias 2006

70 (7) years

68 (11) years

47 (64) months

48 (30) months

16 male, 4 female

14 male, 6 female

Not stated

Not stated

Fisher 2008

Not stated

Not stated

Less than 12 months

Less than 12 months

Not stated

Not stated

Not stated

Not stated

Forrester 2014

63 years

60 years

12 days

11 days

Not stated

Not stated

9 right, 9 left

7 right, 9 left

Geroin 2011

63 (7) years

61 (6) years

26 (6) months

27 (6) months

14 male, 6 female

9 male, 1 female

Not stated

Not stated

Han 2016

68 (15) years

63 (11) years

22 (8) days

18 (10) days

Not stated

Not stated

20 right, 10 left

14 right, 12 left

Hidler 2009

60 (11) years

55 (9) years

111 (63) days

139 (61) days

21 male, 12 female

18 male, 12 female

22 right, 11 left

13 right, 17 left

Hornby 2008

57 (10) years

57 (11) years

50 (51) months

73 (87) months

15 male, 9 female

15 male, 9 female

16 right, 8 left

16 right, 8 left

Husemann 2007

60 (13) years

57 (11) years

79 (56) days

89 (61) days

11 male, 5 female

10 male, 4 female

12 right, 4 left

11 right, 3 left

Kim 2015

54 (13) years

50 (16) years

80 (60) days

120 (84) days

9 male, 4 female

10 male, 3 female

8 right, 5 left

10 right, 3 left

Kyung 2008

48 (8) years

55 (16) years

22 (23) months

29 (12) months

9 male, 8 female

4 male, 4 female

9 right, 8 left

4 right, 4 left

Mayr 2008

Not stated

Not stated

Between 10 days and 6 months

Between 10 days and 6 months

Not stated

Not stated

Not stated

Not stated

Morone 2011

62 (11) years

62 (14) years

19 (11) days

20 (14) days

15 male, 9 female

13 male, 11 female

13 right, 11 left

15 right, 9 left

Noser 2012

67 (9) years

64 (11) years

1354 days

525 days

7 male, 4 female

6 male, 4 female

Not stated

Not stated

Ochi 2015

62 (8) years

66 (12) years

23 (7) days

26 (8) days

11 male, 2 female

9 male, 4 female

6 right, 7 left

5 right, 8 left

Peurala 2005

52 (8) years

52 (7) years

2.5 (2.5) years

4.0 (5.8) years

26 male, 4 female

11 male, 4 female

13 right, 17 left

10 right, 5 left

Peurala 2009

67 (9) years

68 (10) years

8 (3) days

8 (3) days

11 male, 11 female

18 male, 16 female

11 right, 11 left

14 right, 20 left

Picelli 2016

62 (10) years

65 (3) years

6 (4) years

6 (4) years

7 male, 4 female

9 male, 2 female

Not stated

Not stated

Pohl 2007

62 (12) years

64 (11) years

4.2 (1.8) weeks

4.5 (1.9) weeks

50 male, 27 female

54 male, 24 female

36 right, 41 left

33 right, 45 left

Saltuari 2004

62 (13) years

60 (19) years

3.6 (4.6) months

1.9 (0.8) months

4 male, 4 female

2 male, 6 female

Not stated

Not stated

Schwartz 2006

62 (9) years

65 (8) years

22 (9) days

24 (10) days

21 male, 16 female

20 male, 10 female

17 right, 20 left

8 right, 22 left

Stein 2014

58 (11) years

57 (15) years

49 (39) months

89 (153) months

Not stated

Not stated

Not stated

Not stated

Tanaka 2012

63 (10) years

60 (9) years

55 (37) months

65 (67) months

10 male, 2 female

9 right, 3 left

Tong 2006

71 (14) years

64 (10) years

2.5 (1.2) weeks

2.7 (1.2) weeks

19 male, 11 female

12 male, 8 female

13 right, 17 left

7 right, 13 left

Ucar 2014

56 years

62 years

Not stated

Not stated

Not stated

Not stated

Not stated

Not stated

Van Nunen 2012

53 (10) years

2.1 (1.3) months

16 male, 14 female

Not stated

Not stated

Waldman 2013

51 (8) years

53 (7) years

41 (20) months

30 (22) months

Not stated

Not stated

Not stated

Not stated

Watanabe 2014

67 (17) years

76 (14) years

59 (47) days

51 (34) days

7 male, 4 female

4 male, 7 female

6 right, 5 left

5 right, 6 left

Werner 2002

60 (9) years

60 (9) years

7.4 (2.0) weeks

6.9 (2.1) weeks

8 male, 7 female

5 male, 10 female

8 right, 7 left

8 right, 7 left

Westlake 2009

59 (17) years

55 (14) years

44 (27) months

37 (20) months

6 male, 2 female

7 male, 1 female

4 right, 4 left

3 right, 5 left

SD: standard deviation

Open in table viewer
Table 2. Demographics of studies including dropouts and adverse events

Criteria

Stroke severity

Electromechanical device used

Duration of study intervention

Aetiology (ischaemic/haemorrhage)

Intensity of treatment per day

Description of the control intervention

Dropouts

Reasons for dropout

and adverse events in the experimental group

Reasons for dropout and adverse

events in the control group

Source of information

Aschbacher 2006

Not stated

Lokomat

3 weeks

Not stated

30 minutes, 5 times a week

Described as task‐oriented physiotherapy, 5 times a week for 3 weeks (2.5 hours a week)

4 of 23

Not stated

Not stated

Unpublished information in the form of a conference presentation

Bang 2016

Unclear

Lokomat

4 weeks

13/5

60 minutes, 5 times a week (20 sessions)

Described as treadmill training without body weight support

0 of 18

Published information

Brincks 2011

Mean FIM, 92 of 126 points

Lokomat

3 weeks

Not stated

Not stated

Physiotherapy

0 of 13

Unpublished and published information provided by the authors.

Buesing 2015

Unclear

Wearable exoskeleton Stride Management Assist system (SMA)

6 to 8 weeks

Unclear

3 times per week for a maximum of 18 sessions

Functional task‐specific training (intensive overground training and mobility training)

0 of 50

Published information

Chang 2012

Not stated

Lokomat

10 days

Not stated

30 minutes daily for 10 days

Conventional gait training by physical therapists (with equal therapy time and same amount of sessions as experimental group)

3 of 40

Not described by group

(3 participants dropped out:

1 due to aspiration pneumonia, and 2 were unable to co‐operate fully with the experimental procedure)

Unpublished and published information provided by the authors.

Cho 2015

Mean Modified Barthel Index, 36 points

Lokomat

8 weeks (2 phases, cross‐over after 4 weeks)

4/14 (2 both)

30 minutes, 3 times a week for 4 weeks

Bobath (neurophysiological exercises, inhibition of spasticity and synergy pattern)

0 of 20

Published information

Chua 2016

Mean Barthel Index, 49 points

Gait Trainer

8 weeks

Not stated

Not stated

Physiotherapy including 25 minutes of stance/gait, 10 minutes cycling, 10 minutes tilt table standing

20 of 106

2 death, 3 refusal, 1 medical problem, 1 transport problem

(1 pain as adverse event)

1 death, 6 refusal, 3 medical problem, 1 administrative problem

(no adverse events)

Published information

Dias 2006

Mean Barthel Index, 75 points

Gait Trainer

4 weeks

Not stated

40 minutes, 5 times a week

Bobath method, 5 times a week for 5 weeks

0 of 40

Unpublished and published information provided by the authors.

Fisher 2008

Not stated

AutoAmbulator

24 sessions

Not stated

Minimum of 3 sessions a week up to 5 sessions; number of minutes in each session unclear

"Standard" physical therapy, 3 to 5 times a week for 24 consecutive sessions

0 of 20

14 adverse events,

no details provided

11 adverse events,

no details provided

Unpublished and published information provided by the authors.

Forrester 2014

Mean FIM walk 1 point

Anklebot

8 to 10 sessions (with ca. 200 repetitions)

Not stated

60 minutes, 8 to 10 sessions

Stretching of the paretic ankle

5 of 34

Total of 5 dropouts in both groups (1 medical complication, 1 discharge prior study end, 2 time poststroke > 49 days, 1 non‐compliance)

Published information provided by the authors.

Geroin 2011

Mean European Stroke Scale, 80 points

Gait Trainer

2 weeks

Not stated

50 minutes, 5 times a week

Walking exercises according to the Bobath approach

0 of 30

Unpublished and published information provided by the authors.

Han 2016

Not stated

Lokomat

4 weeks

33/23

30 minutes, 5 times a week

Neurodevelopmental techniques for balance and mobility

4 0f 60

4 unclear reasons

Published information provided by the authors.

Hidler 2009

Not stated

Lokomat

8 to 10 weeks (24 sessions)

47/16

45 minutes, 3 days a week

Conventional gait training, 3 times a week for 8 to 10 weeks (24 sessions), each session lasted 1.5 hours

9 of 72

Not described by group

(9 withdrew or were removed because of poor attendance or a decline in health, including 1 death, which according to the authors was unrelated to study)

Unpublished and published information provided by the authors.

Hornby 2008

Not stated

Lokomat

12 sessions

22/26

30 minutes, 12 sessions

Therapist‐assisted gait training, 12 sessions, each session lasted 30 minutes

14 of 62

4 participants dropped out (2 discontinued secondary

to leg pain during training, 1 experienced pitting oedema, and

1 had travel limitations)

10 participants dropped out

(4 discontinued secondary to leg pain, 1 experienced an injury outside therapy, 1 reported fear of

falling during training, 1 presented with significant hypertension,

1 had travel limitations, and

2 experienced

subjective exercise intolerance)

Published information provided by the authors.

Husemann 2007

Median Barthel Index, 35 points

Lokomat

4 weeks

22/8

30 minutes, 5 times a week

Conventional physiotherapy, 30 minutes per day for 4 weeks

2 of 32

1 participant enteritis

1 participant pulmonary embolism

Information as provided by the authors

Kim 2015

Mean Barthel Index, 20 points

Walkbot

4 weeks

13/13

30 minutes, 5 times a week

Conventional physiotherapy (bed mobility, stretching, balance training, strengthening, symmetry training, treadmill training)

4 of 30

1 rib fracture, 3 decline in health condition

Information as provided by the authors

Kyung 2008

Not stated

Lokomat

4 weeks

18/7

45 minutes, 3 days a week

Conventional physiotherapy, received equal time and sessions of conventional gait training

10 of 35

1 participant dropped out for

private reasons (travelling);

adverse events not described

9 participants refused after randomisation (reasons not provided); adverse events not described

Unpublished and published information provided by the authors.

Mayr 2008

Not stated

Lokomat

8 weeks

Not stated

Not stated

Add‐on conventional physiotherapy, received equal time and sessions of conventional gait training

13 of 74

4 participants dropped out (reasons not provided); adverse events not described

9 participants dropped out (reasons not provided)

Unpublished and published information provided by the authors.

Morone 2011

Canadian Neurological Scale, 6 points

Gait Trainer

4 weeks

41/7

40 minutes, 5 times a week

Focused on trunk stabilisation, weight transfer to the paretic leg, and walking between parallel
bars or on the ground. The participant was helped by 1 or 2 therapists and walking aids if necessary.

21 of 48

12 (hypotension, referred weakness, knee pain, urinary infection, uncontrolled blood pressure, fever, absence of physiotherapist)

9 (hypotension, referred weakness, knee pain, ankle pain, uncontrolled blood pressure, fever, absence of physiotherapist)

Information as provided by the authors

Noser 2012

Not stated

Lokomat

Unclear

Not stated

Not stated

Not stated

1 of 21

No dropouts;

2 serious adverse events

(1 skin breakdown as a result of therapy,

1 second stroke during the post‐treatment phase)

1 dropout due to protocol violation;

2 serious adverse events

(1 sudden drop in blood pressure at participant's home leading to brief hospitalisation,

1 sudden chest pain before therapy leading to brief hospitalisation)

Information as provided by the authors

Ochi 2015

Not stated

Gait‐assistance robot (consisting of 4 robotic arms for the thighs and legs, thigh cuffs, leg apparatuses, and a treadmill)

4 weeks

10/16

20 minutes, 5 times a week for 4 weeks, in addition to rehabilitation treatment

Range‐of‐motion exercises, muscle strengthening, rolling over and sit‐to‐stand and activity and gait exercises

0 of 26

Published information

Peurala 2005

Scandinavian Stroke Scale, 42 points

Gait Trainer

3 weeks

25/20

20 minutes, 5 times a week for 3 weeks, in addition to rehabilitation treatment

Walking overground;

all participants practised gait for 15 sessions over 3 weeks (each session lasting 20 minutes)

0 of 45

Published information

Peurala 2009

Not stated

Gait Trainer

3 weeks

42/14

20 minutes, 5 times a week for 3 weeks, in addition to rehabilitation treatment

Overground walking training; in the other control group, 1 or 2 physiotherapy sessions daily but not at the same intensity as in the other groups

9 of 56

5 dropouts

(2 situation worsened after 1 to 2 treatment days;

1 had 2 unsuccessful attempts in device;

1 had scheduling problems;

1 felt protocol too demanding)

4 dropouts

(1 felt protocol too demanding;

2 situation worsened after 1 to 2 treatment days;

1 death)

Published information

Picelli 2016

Not stated

G‐EO System Evolution

Experimental group (G‐EO) 30 minutes a day for 5 consecutive days

Not stated

5 days in addition to botulinum toxin injection of calf muscles

None

0 of 22

Published information

Pohl 2007

Mean Barthel Index, 37 points

Gait Trainer

4 weeks

124/31

20 minutes, 5 times a week

Physiotherapy every weekday for 4 weeks

11 of 155

2 participants refused therapy,

1 increased cranial pressure,

1 relapsing pancreas tumour,

1 cardiovascular unstable

4 participants refused therapy, 1 participant died, 1 myocardial infarction

Published information

Saltuari 2004

Not stated

Lokomat

2 weeks

13/3

A‐B‐A study: in phase A, 30 minutes, 5 days a week

Physiotherapy every weekday for 3 weeks (phase B)

0 of 16

None

None

Unpublished and published information provided by the authors.

Schwartz 2006

Mean NIHSS, 11 points

Lokomat

6 weeks

49/67

30 minutes, 3 times a week

Physiotherapy with additional gait training 3 times a week for 6 weeks

6 of 46

2 participants with leg wounds,

1 participant with recurrent stroke,

1 refused therapy

1 participant with recurrent stroke,

1 with pulmonary embolism

Unpublished and published information provided by the authors.

Stein 2014

Not stated

Bionic leg device (AlterG)

6 weeks

Not stated

1 hour, 3 times a week for 6 weeks

Group exercises

0 of 24

Published information

Tanaka 2012

Mean FIM, 79 points

Gait Master4

4 weeks

Not stated

20 minutes, 2 or 3 times a week (12 sessions)

Non‐intervention (non‐training)

0 of 12

Published information

Tong 2006

Mean Barthel Index, 51 points

Gait Trainer

4 weeks

39/11

20 minutes, 5 times a week

Conventional physiotherapy alone, based on Bobath concept

4 of 50

None

2 participants discharged before study end,

1 participant readmitted to an acute ward,

1 participant deteriorating condition

Published information

Ucar 2014

Not stated

Lokomat

2 weeks

Not stated

30 minutes, 5 times a week

Conventional physiotherapy at home (focused on gait)

0 of 22

Published information

Van Nunen 2012

Not stated

Lokomat

8 weeks

Not stated

30 minutes, twice a week

Overground therapy

0 of 30

Unpublished and published information provided by the author.

Waldman 2013

Not stated

Portable rehab robot (ankle device)

6 weeks

Not stated

3 times a week, 18 sessions

Stretching the plantar flexors and active exercises for ankle mobility and strength

0 of 24

Published information

Watanabe 2014

Not stated

Single‐leg version of the Hybrid Assistive Limb (HAL)

4 weeks

11/11

20 minutes, 12 sessions

Aimed to improve walking speed, endurance, balance, postural stability, and symmetry

10 of 32

4 withdrew,

1 epilepsy,

1 technical reasons

2 pneumonia,

2 discharged

Published information

Werner 2002

Mean Barthel Index, 38 points

Gait Trainer

2 weeks

13/12

20 minutes, 5 times a week

Gait therapy including treadmill training with body weight support

0 of 30

None

None

Published information

Westlake 2009

Not stated

Lokomat

4 weeks (12 sessions)

8/8

30 minutes, 3 times a week

12 physiotherapy sessions including manually guided gait training (3 times a week over 4 weeks)

0 of 16

None

None

Published information

FIM: Functional Independence Measure
NIHSS: National Institutes of Health Stroke Scale

For one of the included studies published only as an abstract we obtained at least some results through correspondence with the trial co‐ordinator or principal investigator (Mayr 2008). Another study was not yet published, but the results of the trial were presented orally, and we were able to obtain a handout with information about the study from the principal investigator (Aschbacher 2006).

A detailed description of all participant characteristics can be found in Table 1 and Table 2 (see also the Characteristics of included studies). The mean age in the included studies ranged from 48 years, in Kyung 2008, to 76 years, in Watanabe 2014 (Table 1). More males than females were included the studies (approximately 60% males). More participants with ischaemic stroke than haemorrhagic stroke lesions (approximately 70% ischaemic stroke) were included, and almost as many participants with left‐sided hemiparesis compared with participants with right‐sided hemiparesis (approximately 50% left‐sided) were included in the studies (see Table 1 and Table 2).

Twelve studies provided information about baseline stroke severity (Table 2), of which seven used the Barthel Index score, ranging from 20 Barthel Index points, in Kim 2015, to 75 of 100 Barthel Index points, in Dias 2006 (Table 2). Details of all inclusion and exclusion criteria used in the studies can be found in the Characteristics of included studies table.

The duration of study intervention (time frame during which experimental interventions were applied) was heterogeneous, ranging from 10 days, in Chang 2012, to eight weeks, in Mayr 2008. The study intervention period for most studies was three or four weeks (Table 2). Fifteen of the 36 studies included participants who could walk independently at the start of the study; a further nine studies included participants who were dependent and independent walkers (Analysis 4.1); and 12 studies included only non‐ambulatory participants (Analysis 4.1). The experimental intervention in 17 studies was the robotic‐assisted device Lokomat, and the experimental intervention in nine studies was the electromechanical‐assisted device Gait Trainer; a detailed description of devices used in studies can be found in Table 2.

Frequency (in terms of therapy provided per week) of treatment ranged from two or three times a week, in Tanaka 2012, to five times a week (Table 2). Intensity (in terms of duration of experimental therapy provided) of treatment ranged from 20 minutes, in Werner 2002, to 60 minutes, in Forrester 2014. In many studies, details of the interventions were unclear or incomplete, for example details about the intensity of the experimental treatment were unclear in some studies (Table 2). Except for Tanaka 2012 and Picelli 2016, the gait training time did not differ between control and experimental groups in the included studies. Eleven included studies used a follow‐up assessment after the study ended (Buesing 2015; Chua 2016; Dias 2006; Hidler 2009; Hornby 2008; Peurala 2005; Peurala 2009; Pohl 2007; Schwartz 2006; Stein 2014; Waldman 2013). Most studies investigated improvement in walking function as a primary outcome for analysis and used the Functional Ambulation Category (FAC) or comparable scales to assess independent walking. Furthermore, frequently investigated outcomes included assessment of walking function using gait velocity in metres per second. A more detailed description of the primary and secondary outcomes for each trial can be found in the Characteristics of included studies table.

We found the highest dropout rates for all reasons at the end of the treatment phase to be 23%, in Hornby 2008, and 29%, in Kyung 2008. Seventeen trialists reported no dropouts at scheduled follow‐up (Analysis 1.7; Table 2).

Excluded studies

We excluded 24 studies (see Characteristics of excluded studies and Figure 1 for further information).

Ongoing studies and studies awaiting assessment

We identified 16 ongoing studies (see Characteristics of ongoing studies). Thirteen studies for which we were unable to make contact with the trialists are still awaiting assessment (see Characteristics of studies awaiting classification).

Risk of bias in included studies

The risk of bias in included studies is described in greater detail in Characteristics of included studies and Figure 2.


Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

We wrote to the trialists of all included studies and studies awaiting assessment to request clarification of design features or for missing information to complete the quality ratings. We sent the correspondence via email or letter, followed by reminders every month if we received no response. Most trialists provided at least some of the requested data, but we were not able to obtain all of the required data.

Two review authors (JM, MP) used the 'Risk of bias' assessment tool to independently assess the methodological quality of the studies for the domains random sequence generation, allocation concealment, blinding of outcome assessment, and incomplete outcome data for all of the included trials except two (Pohl 2007; Werner 2002), which two other review authors (BE, JK) rated in an interview with the trialists. The review authors discussed all disagreements and sought arbitration by another review author (JK or BE) if necessary.

Allocation

Of the 36 included studies, 20 described adequate random sequence generation, and 17 described adequate allocation concealment.

Blinding

Of the 36 included studies, 6 reported blinding of the primary outcome assessment.

Incomplete outcome data

Of the 36 included studies, 14 reported incomplete outcome data (attrition bias).

Selective reporting

For the majority of studies, particularly the older trials, we did not find study protocols. Where study protocols were available, there was no evidence of selective reporting of outcomes relevant to this review.

Other potential sources of bias

Five out of 36 included trials used a cross‐over design with random allocation to the order of treatment sequences (Brincks 2011; Cho 2015; Saltuari 2004; Tanaka 2012; Werner 2002). We analysed only the first intervention period as a parallel‐group trial in this review. All other included studies used a parallel‐group design with true randomisation to group allocation.

Three studies used two experimental groups and one control group (Geroin 2011; Peurala 2005; Tong 2006), and one study used one experimental group and two control groups (Peurala 2009). In the former three studies (Geroin 2011; Peurala 2005; Tong 2006), additional functional electrical stimulation of leg muscles (or transcranial stimulation of the brain in Geroin 2011) during gait training was applied in one of the treatment groups. Because functional electrical stimulation or transcranial stimulation of the brain was done as an adjunct during electromechanical‐assisted gait training, and because the results in these experimental groups did not differ significantly, we combined the results of both experimental groups into one (collapsed) group and compared this with the results from the control group. In one study, an electromechanical‐assisted device was used in the experimental group and was compared with two control groups that did not use a device (Peurala 2009). Because we were interested in the effects of electromechanical‐ and robotic‐assisted gait‐training devices for improving walking after stroke, we combined the results of both control groups without devices into one (collapsed control) group and compared this with results of the one experimental group.

Effects of interventions

See: Summary of findings for the main comparison Electromechanical‐ and robotic‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke

Independent walking at the end of the intervention phase, all electromechanical devices used

Thrity‐six trials with a total of 1472 participants measured independent walking at study end, but for 21 included trials, no effect estimate (odds ratio (OR)) was feasible because no events (e.g. no participant reached the ability to walk) or only events (e.g. all participants regained walking) were reported (Analysis 1.1) (Deeks 2011).

The use of electromechanical devices in gait rehabilitation for people after stroke increased the chance of walking independently (OR 1.94, 95% confidence interval (CI) 1.39 to 2.71; P < 0.001; level of heterogeneity I² = 8%; moderate‐quality evidence; summary of findings Table for the main comparison). However, 15 out of 36 studies investigated at least some participants who were already independent in walking at the start of the study. A further nine studies included participants who were dependent and independent walkers, and 12 studies included only non‐ambulatory participants (Analysis 4.1). Of the total population of 1472 participants, approximately 39% were independent and approximately 59% were dependent walkers at the start of the study.

Recovery of independent walking at follow‐up after study end

Six trials with a total of 496 participants measured recovery of independent walking with follow‐up after the study end (Chua 2016; Hidler 2009; Hornby 2008; Peurala 2009; Pohl 2007; Tong 2006), but for two included trials (with 125 participants), no effect estimate (OR) was feasible because no events (e.g. no participant reached ability to walk) or only events (e.g. all participants regained walking) were reported (Analysis 1.2). The use of electromechanical devices for gait rehabilitation of people after stroke did not increase the chance of walking independently at follow‐up after study end (OR 1.93, 95% CI 0.72 to 5.13; P = 0.19; level of heterogeneity I² = 79%; moderate‐quality evidence). However, some included trials investigated participants who were already independent in walking at the start of the study. We could draw no definitive conclusion regarding a longer‐lasting effect of the use of electromechanical devices.

Walking velocity (metres per second) at the end of the intervention phase

Twenty‐four trials with a total of 985 participants provided data for walking velocity (m/s) at study end (Analysis 1.3). The use of electromechanical devices for gait rehabilitation did not significantly increase walking velocity. The pooled mean difference (MD) (random‐effects model) for walking velocity was 0.04 m/s (95% CI 0.00 to 0.09; P = 0.08; level of heterogeneity I² = 65%; low‐quality evidence). Participants who were unable to walk were regarded as having a walking velocity of zero metres per second.

Walking velocity (metres per second) at follow‐up

Nine trials with a total of 578 participants provided data for walking velocity (m/s) at follow‐up after study end (Buesing 2015; Chua 2016; Hidler 2009; Hornby 2008; Kyung 2008; Noser 2012; Pohl 2007; Stein 2014; Tong 2006). The use of electromechanical devices for gait rehabilitation did not significantly increase the walking velocity at follow‐up after study end. The pooled MD (random‐effects model) for walking velocity was 0.07 m/s (95% CI ‐0.05 to 0.19; P = 0.26; level of heterogeneity I² = 80%; moderate‐quality evidence; Analysis 1.4). Participants who were unable to walk were regarded as having a walking velocity of zero metres per second. We could draw no definitive conclusion regarding a longer‐lasting effect of the use of electromechanical devices for walking velocity.

Walking capacity (metres walked in 6 minutes) at the end of the intervention phase

Twelve trials with a total of 594 participants provided data for walking capacity (metres walked in 6 minutes) at study end (Chua 2016; Hidler 2009; Hornby 2008; Noser 2012; Peurala 2005; Picelli 2016; Pohl 2007; Saltuari 2004; Stein 2014; Waldman 2013; Watanabe 2014; Westlake 2009). The use of electromechanical devices in gait rehabilitation did not increase the walking capacity of people after stroke. The pooled MD (random‐effects model) for walking capacity was 5.84 metres walked in 6 minutes (95% CI ‐16.73 to 28.40; P = 0.61; level of heterogeneity I² = 53%; very low‐quality evidence; Analysis 1.5).

Walking capacity (metres walked in 6 minutes) at follow‐up

Seven trials with a total of 463 participants provided data for walking capacity (metres walked in 6 minutes) at follow‐up after study end (Chua 2016; Hidler 2009; Hornby 2008; Noser 2012; Pohl 2007; Stein 2014; Waldman 2013). The use of electromechanical devices for gait rehabilitation did not increase walking capacity at follow‐up after study end. The pooled MD (random‐effects model) for walking capacity was ‐0.82 metres walked in 6 minutes (95% CI ‐32.17 to 30.53; P = 0.96; level of heterogeneity I² = 58%; very low‐quality evidence; Analysis 1.6).

Death from all causes until the end of the intervention phase

Only three larger trials reported any deaths during the intervention period (Chua 2016; Hidler 2009; Pohl 2007). In Pohl 2007 one participant in the control group died as the result of aspiration pneumonia, and one participant in the treatment group died due to recurrent stroke. In Hidler 2009, the group in which the death occurred was not stated. We therefore used a worst‐case (conservative) scenario and counted the one death for the experimental group. In the study of Chua 2016 the deaths occurred after the treatment period. The use of electromechanical devices for gait rehabilitation of non‐ambulatory people after stroke did not increase the risk of participants dying during the intervention period (risk difference (random‐effects model) 0.00, 95% CI ‐0.01 to 0.02; P = 0.77; level of heterogeneity I² = 0%; moderate‐quality evidence; Analysis 1.8).

Adverse outcomes: acceptability of electromechanical‐assisted gait‐training devices during the intervention phase in terms of dropouts

All trialists provided information about participants who dropped out from all causes during the trial period, but for 17 of the 36 included trials, no events/dropouts were reported (Analysis 1.7). The use of electromechanical devices for gait rehabilitation of non‐ambulatory people after stroke did not increase the risk of participants dropping out (OR (random‐effects model) 0.67, 95% CI 0.43 to 1.05; P = 0.08; level of heterogeneity I² = 24%; low‐quality evidence). The reasons for dropouts and all adverse events are described in detail for each trial in Table 2.

Regaining independent walking ability: planned sensitivity analysis by trial methodology

To examine the robustness of the results, we specified variables in a sensitivity analysis that we believed could influence the size of the observed effect (adequate sequence generation process, adequate concealed allocation, blinded assessors for the primary outcome, incomplete outcome data, and excluding the largest study). As stated above, for some of the included trials, no effect estimate (OR) was feasible (Analysis 2.1).

Studies with adequate sequence generation process

We included 20 trials with a total of 949 participants with an adequate sequence generation process (Figure 2). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.80, 95% CI 1.06 to 3.08; P = 0.03; level of heterogeneity I² = 38%).

Studies with adequate concealed allocation

We included 17 trials with a total of 831 participants with adequate concealed allocation (Figure 2). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.87, 95% CI 1.12 to 3.12; P = 0.02; level of heterogeneity I² = 37%).

Studies with blinded assessors for the primary outcome

Sixteen trials with a total of 762 participants had blinded assessors for the primary outcome (Figure 2). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.81, 95% CI 1.10 to 2.98; P = 0.02; level of heterogeneity I² = 31%).

Studies with complete outcome data

Fourteen trials with a total of 590 participants adequately described complete outcome data (Figure 2). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 2.23, 95% CI 1.16 to 4.29; P = 0.02; level of heterogeneity I² = 29%).

Excluding the largest study (Pohl 2007)

After excluding the largest study (Pohl 2007), 35 trials with a total of 1317 participants remained in this analysis. The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.65, 95% CI 1.17 to 2.34; P = 0.005; level of heterogeneity I² = 0%).

Subgroup analysis comparing participants in the acute and chronic phases of stroke

Independent walking at the end of the intervention phase, all electromechanical devices used

In our planned subgroup analysis comparing independent walking at the end of the intervention phase in people in the acute and chronic phases of stroke, we attempted to assign all included studies to one of two subgroups (acute and chronic phases).

Twenty trials with a total of 1143 participants investigated people in the acute or subacute phase, defined as less than or equal to three months after stroke (Analysis 3.1). As stated in the comparisons above, for some of the included trials no effect estimate (OR) was feasible (Analysis 3.1). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.90, 95% CI 1.38 to 2.63; P < 0.001; level of heterogeneity I² = 5%).

Sixteen trials with a total of 461 participants investigated people in the chronic phase, defined as more than three months after stroke (Analysis 3.1). The use of electromechanical devices for gait rehabilitation of people after stroke did not increase the chance of walking independently (OR (random‐effects model) 1.20, 95% CI 0.40 to 3.65; P = 0.74; level of heterogeneity I² = 29%).

In a formal subgroup analysis, we did not find statistically significant differences in regaining independent walking between participants treated in the acute/subacute phase compared with participants treated in the chronic phase after stroke (Chi² = 0.61, df = 1; P = 0.44).

Post hoc sensitivity analysis by ambulatory status at study onset

Independent walking at the end of the intervention phase

To examine the robustness of the results and to explore the relationship between the main effect and walking status at the start of the study, we compared independent walking rates at the end of the intervention phase by ambulatory status at start of study.

Ambulatory participants at start of study

Fifteen trials with a total of 500 participants investigated independent walkers (Analysis 4.1). As stated in the comparisons above, for some of the included trials, no effect estimate (OR) was feasible; the conclusions are therefore based on one trial. The use of electromechanical devices for gait rehabilitation of people after stroke did not increase the chance of walking independently (OR (random‐effects model) 1.38, 95% CI 0.45 to 4.20; P = 0.57; level of heterogeneity I² = not applicable).

Ambulatory and non‐ambulatory participants at start of study

Nine trials with a total of 340 participants investigated a mixed population of dependent and independent walkers (Analysis 4.1). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.90, 95% CI 1.11 to 3.25; P = 0.02; level of heterogeneity I² = 0%).

Non‐ambulatory participants at start of study

Twelve trials with a total of 632 participants investigated dependent walkers (Analysis 4.1). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 1.90, 95% CI 1.04 to 3.48; P = 0.04; level of heterogeneity I² = 45%).

In a subgroup analysis, we did not find statistically significant differences between people who were dependent or independent walkers at the start of the study in regaining independent walking (Chi² = 0.28, df = 2; P = 0.87).

Walking speed at the end of the intervention phase

To examine the robustness of the results and to explore the relationship between walking velocity and ambulatory status at the start of the study, we compared achieved walking velocity at the end of the intervention phase by ambulatory status at the start of the study.

Ambulatory participants at start of study

Ten trials with a total of 317 participants investigated independent walkers at the start of the study and provided data for walking velocity (m/s) at study end (Analysis 4.2). The use of electromechanical devices for gait rehabilitation did not significantly increase walking velocity. The pooled MD (random‐effects model) for walking velocity was ‐0.02 m/s (95% CI ‐0.10 to 0.06; P = 0.66; level of heterogeneity I² = 59%).

Ambulatory and non‐ambulatory participants at start of study

Five trials with a total of 146 participants investigated dependent and independent walkers at the start of the study and provided data for walking velocity (m/s) at study end (Analysis 4.2). The use of electromechanical devices for gait rehabilitation did not significantly increase walking velocity. The pooled MD (random‐effects model) for walking velocity was 0.03 m/s (95% CI ‐0.05 to 0.11; P = 0.44; level of heterogeneity I² = 0%).

Non‐ambulatory participants at start of study

Nine trials with a total of 522 participants investigated dependent walkers at the start of the study and provided data for walking velocity (m/s) at study end (Analysis 4.2). The use of electromechanical devices for gait rehabilitation significantly increased walking velocity. The pooled MD (random‐effects model) for walking velocity was 0.10 m/s (95% CI 0.03 to 0.17; P = 0.006; level of heterogeneity I² = 73%).

In a subgroup analysis, we did not find statistically significant differences in regaining independent walking between participants who were dependent or independent walkers at the start of the study (Chi² = 4.55, df = 2; P = 0.10).

Post hoc sensitivity analysis by type of electromechanical device

Independent walking at the end of the intervention phase

To examine the robustness of the results and to explore the relationship between independent walking and type of electromechanical device, we compared achieved independent walking rates at the end of the intervention phase by type of electromechanical device.

End‐effector devices

Eleven trials with a total of 598 participants used an end‐effector device as the experimental intervention (Table 2). As stated in the comparisons above, for some of the included trials, no effect estimate (OR) was feasible (Analysis 5.1). The use of electromechanical devices for gait rehabilitation of people after stroke did not increase the chance of walking independently (OR (random‐effects model) 1.90, 95% CI 0.99 to 3.63; P = 0.05; level of heterogeneity I² = 50%).

Exoskeleton devices

Sixteen trials with a total of 585 participants used an exoskeleton device as the experimental intervention (Table 2). The use of electromechanical devices for gait rehabilitation of people after stroke increased the chance of walking independently (OR (random‐effects model) 2.05, 95% CI 1.21 to 3.50; P = 0.008; level of heterogeneity I² = 0%).

We did not find statistically significant differences in regaining independent walking between participants treated with end‐effector or exoskeleton devices (Chi² = 0.04, df = 1; P = 0.85).

Mobile devices

Three trials with a total of 106 participants used powered mobile devices as the experimental intervention (Table 2), but the effects on walking ability were not estimable.

Ankle devices

Two trials with a total of 63 participants used ankle devices while sitting as the experimental intervention (Table 2), but the effects on walking ability were not estimable.

We did not find statistically significant differences in regaining independent walking by type of electromechanical device (end‐effector, exoskeleton, mobile or ankle device)(Chi² = 0.04, df = 1; P = 0.85).

Walking speed at the end of the intervention phase

To examine the robustness of the results and to explore the relationship between independent walking and type of electromechanical device, we compared the walking speed at the end of the intervention phase by type of electromechanical device.

End‐effector devices

Nine trials with a total of 519 participants used an end‐effector device as the experimental intervention and provided data for walking velocity (m/s) at study end (Analysis 5.2). The use of electromechanical devices for gait rehabilitation significantly increased walking velocity. The pooled MD (random‐effects model) for walking velocity was 0.11 m/s (95% CI 0.04 to 0.18; P = 0.003; level of heterogeneity I² = 73%).

Exoskeleton devices

Twelve trials with a total of 360 participants used an exoskeleton device as the experimental intervention and provided data for walking velocity (m/s) at study end (Analysis 5.2). The use of electromechanical devices for gait rehabilitation did not increase walking velocity. The pooled MD (random‐effects model) for walking velocity was ‐0.02 m/s (95% CI ‐0.08 to 0.04; P = 0.60; level of heterogeneity I² = 44%).

In a formal subgroup analysis, we found statistically significant differences in improvement in walking velocity between participants treated with an end‐effector device or an exoskeleton device (Chi² = 6.79, df = 1; P = 0.009; I² = 85.3%).

Mobile devices

Three trials with a total of 106 participants used powered mobile devices as the experimental intervention and provided data for walking velocity (m/s) at study end (Analysis 5.2). The use of electromechanical devices for gait rehabilitation did not increase walking velocity. The pooled MD (random‐effects model) for walking velocity was 0.02 m/s (95% CI ‐0.11 to 0.15; P = 0.78; level of heterogeneity I² = 0%).

Ankle devices

One trial with 39 participants used an ankle mobile device as the experimental intervention and provided data for walking velocity (m/s) at study end (Analysis 5.2). The use of electromechanical devices for gait rehabilitation increased walking velocity. The MD (random‐effects model) for walking velocity was 0.04 m/s (95% CI 0.01 to 0.07; P = 0.02; level of heterogeneity not applicable).

In a subgroup analysis, we did not find statistically significant differences in improvement in walking velocity by type of electromechanical device (end‐effector, exoskeleton, mobile or ankle device)(Chi² = 6.56, df = 3; P = 0.09; I² = 54.3%).

Walking capacity at the end of the intervention phase

To examine the robustness of the results and to explore the relationship between independent walking and type of electromechanical device, we compared the walking capacity at the end of the intervention phase by type of electromechanical device.

End‐effector devices

Four trials with a total of 328 participants used an end‐effector device as the experimental intervention and provided data for walking capacity (metres) at study end (Analysis 5.3). The use of electromechanical devices for gait rehabilitation significantly increased walking capacity. The pooled MD (random‐effects model) for walking capacity was 27.5 m (95% CI 3.63 to 51.36; P = 0.02; level of heterogeneity I² = 4%).

Exoskeleton devices

Five trials with a total of 186 participants used an exoskeleton device as the experimental intervention and provided data for walking capacity (metres) at study end (Analysis 5.3). The use of electromechanical devices for gait rehabilitation did not increase walking capacity. The pooled MD (random‐effects model) for walking capacity was ‐15.64 m (95% CI ‐46.34 to 15.05; P = 0.32; level of heterogeneity I² = 51%).

In a formal subgroup analysis, we found statistically significant differences in improvement in walking capacity between participants treated with an end‐effector device or an exoskeleton device (Chi² = 4.73, df = 1; P = 0.03; I² = 78.9%).

Mobile devices

Two trials with a total of 56 participants used powered mobile devices as the experimental intervention and provided data for walking capacity (metres) at study end (Analysis 5.3). The use of electromechanical devices for gait rehabilitation did not increase walking capacity. The pooled MD (random‐effects model) for walking capacity was 20.06 m (95% CI ‐39.52 to 79.63; P = 0.51; level of heterogeneity I² = 0%).

Ankle devices

One trial with 24 participants used an ankle mobile device as the experimental intervention and provided data for walking capacity (metres) at study end (Analysis 5.3). The use of electromechanical devices for gait rehabilitation did not increase walking capacity. The MD (random‐effects model) for walking capacity was 8.0 m (95% CI ‐83.03 to 99.03; P = 0.86; level of heterogeneity not applicable).

In a subgroup analysis, we did not find statistically significant differences in improvement in walking capacity between participants treated by type of electromechanical device (end‐effector, exoskeleton, mobile or ankle device) (Chi² = 4.81, df = 3; P = 0.19; I² = 37.7%).

Discussion

Summary of main results

The aim of this review was to evaluate the effects of electromechanical‐ and robotic‐assisted gait‐training devices (with body weight support) for improving walking after stroke. We sought to estimate the likelihood or chance of becoming independent in walking as a result of these interventions, which is a main rehabilitation goal for people who have had a stroke (Bohannon 1988; Bohannon 1991).

We included 36 trials with a total of 1472 participants and found evidence that the use of electromechanical‐assisted devices in combination with physiotherapy in rehabilitation settings may improve walking function after stroke.

Furthermore, adverse events, dropouts, and deaths do not appear to be more frequent in participants who received electromechanical‐ or robotic‐assisted gait training, which indicates that the use of electromechanical‐assisted gait‐training devices was safe and acceptable to most participants included in the trials analysed by this review.

The exclusion of certain patient groups, such as people over 80 years of age, people with unstable cardiovascular conditions, people with cognitive and communication deficits, and people with a limited range of motion in the lower limb joints at the start of the intervention, may limit the general applicability of the findings. However, using the results from the primary outcomes, it is possible to explore the apparent effectiveness of electromechanical‐assisted devices for regaining walking ability. Of 761 participants in the treatment group, 412 (54%) were walking independently at the end of the intervention phase. We used the primary outcome of independently walking at the end of the intervention phase for all included participants (OR 1.94) to calculate the number needed to treat for an additional beneficial outcome (NNTB). Together with our control event rate of 45% (325 out of 711 control participants were independently walking), we calculated an NNTB of 7 (95% CI 6 to 8) (Sackett 1996). This means that every seventh dependency in walking ability after stroke could be avoided with the use of electromechanical‐assisted devices. However, the optimum amount of electromechanical‐assisted gait training (optimal frequency, optimal duration in the use of assistive technologies and timing of application) remains unclear.

It appears that people in the acute and subacute phases after stroke profit more than people treated more than three months poststroke from this type of therapy (Analysis 3.1). This means that people may benefit more from electromechanical‐ and robotic‐assisted gait training in the first three months after stroke than after three months poststroke.

We argue that 582 (39%) of the 1472 included participants were independently walking at baseline (see Description of studies and the Characteristics of included studies table). Because people who are already ambulatory cannot regain or recover independent walking, our effect estimate could have been influenced by performance bias. We therefore performed two further sensitivity analyses by ambulatory status at the start of the study (Analysis 4.1 and Analysis 4.2).

We found that studies that included mainly dependent walkers (i.e. participants who were non‐ambulatory at the start of the study) were more likely to report that these participants were able to walk at study end and to reach greater walking velocities at the end of the intervention phase compared with participants who were already ambulatory at the start of the study (Analysis 4.1; Analysis 4.2). This means that ambulatory people do not benefit from electromechanical‐ and robotic‐assisted gait training.

We found that the ability to walk at study end was not dependent on the type of device used in the studies (Analysis 5.1). However, walking velocities at the end of the intervention phase were higher when end‐effector devices were used compared with participants who received training by an exoskeleton device (Analysis 5.2), meaning that the type of device used could play a role in improving walking function after stroke. This is in line with the former version of this review from 2013, Mehrholz 2013, and another review that compared the effects of different types of devices on walking ability after stroke (Mehrholz 2012a). However, in the absence of a direct empirical comparison between electromechanical‐assisted gait‐training devices, this point warrants further investigation.

Overall completeness and applicability of evidence

In all systematic reviews the risk of publication bias is present. However, we performed an extensive search for relevant literature in electronic databases and handsearched conference abstracts. Additionally, we contacted and asked authors, trialists, and experts in the field for other unpublished and ongoing trials.

Upon visual inspection, we did not detect graphical evidence of publication bias (see Figure 3 and Figure 4).


Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.1 Independent walking at the end of intervention phase, all electromechanical devices used.

Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.1 Independent walking at the end of intervention phase, all electromechanical devices used.


Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.3 Walking velocity (metres per second) at the end of intervention phase.

Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.3 Walking velocity (metres per second) at the end of intervention phase.

Given that we found several ongoing studies of substantial size, it is possible that these ongoing studies could potentially impact our overall conclusion when they are included in the review (see Characteristics of ongoing studies).

It is not clear whether the observed differences between experimental and control groups depend on the intensity of therapy, in terms of repetitions of gait practice. Time devoted to therapy is a crude measure of intensity. A 30‐minute therapy session could include no walking practice or high‐intensity walking practice with many steps taken. Reviews of the effectiveness of arm robotic therapy suggest that the positive benefit of robotic therapy may be lost when the intensity of practice is matched between experimental and control groups (Mehrholz 2012b). However, the numbers of repetitions in the experimental and control groups were not exactly counted in any of the included studies. Further studies should therefore ascertain whether the benefits described here are still apparent when the intensity of gait practice (e.g. step repetitions) is exactly matched between groups.

It should be mentioned that we do not know yet whether these devices provide any cost benefit. Further studies should investigate, under the premise that gait practice is matched in terms of objective measures of intensity, the long‐term costs of regaining walking ability and the cost‐effectiveness of these devices.

Quality of the evidence

There was heterogeneity between the trials in terms of trial design (two arms, three arms, parallel‐group or cross‐over trial, duration of follow‐up, and selection criteria for participants), characteristics of the therapy interventions (especially duration of the intervention), and participant characteristics (length of time since stroke onset and stroke severity at baseline). We noted methodological differences in the mechanisms of randomisation and in the allocation concealment methods used, as well as in the blinding of primary outcomes and the presence or use of intention‐to‐treat analysis.

After examining the effects of methodological quality on the odds of independence in walking, we found that the benefits were relatively robust when we removed trials with an inadequate sequence generation process, inadequate concealed allocation, no blinded assessors for the primary outcome, and incomplete outcome data (Analysis 2.1). However, we found that the odds of independence in walking were slightly lower after the largest included study (Pohl 2007, N = 155) was removed, but a statistically significant and clinically relevant benefit for participants is still observed.

Although the methodological quality of the included trials seemed generally good to moderate (Figure 2), trials investigating electromechanical‐ and robotic‐assisted gait‐training devices are subject to potential methodological limitations. These include inability to blind the therapist and participants, so‐called contamination (provision of the intervention to the control group), and co‐intervention (when the same therapist unintentionally provides additional care to either treatment or comparison group). All these potential methodological limitations introduce the possibility of performance bias. However, as discussed previously, this was not supported in our sensitivity analyses by methodological quality.

The quality of the evidence for automated electromechanical‐ and robotic‐assisted gait‐training devices for improving walking after stroke was moderate. The quality of the evidence was low for walking speed, very low for walking capacity, and low for adverse events and people discontinuing treatment.

Potential biases in the review process

In all systematic reviews the risk of publication bias is present. However, we performed an extensive search for relevant literature in electronic databases and handsearched conference abstracts. Additionally, we contacted and asked authors, trialists, and experts in the field for other unpublished and ongoing trials.

Upon visual inspection, we did not detect graphical evidence of publication bias (see Figure 3 and Figure 4).

Given that we found several ongoing studies of substantial size, it is possible that these ongoing studies could potentially impact our overall conclusion (see Characteristics of ongoing studies).

Agreements and disagreements with other studies or reviews

The most recent and relevant review describes the effects of new so‐called powered mobile solutions (Louie 2016). We included three studies of mobile devices in this update. When pooling these results, we did not find significant improvements in walking speed and walking capacity; this result is in agreement with the recent review of Louie 2016. Additionally, there are two new studies describing the effects of ankle robots (Forrester 2014; Waldman 2013) to improve walking were described. When pooling these studies, we did not find significant improvements in walking speed and walking capacity. We are not aware of any systematic review about this type of devices so far.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.1 Independent walking at the end of intervention phase, all electromechanical devices used.
Figures and Tables -
Figure 3

Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.1 Independent walking at the end of intervention phase, all electromechanical devices used.

Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.3 Walking velocity (metres per second) at the end of intervention phase.
Figures and Tables -
Figure 4

Funnel plot of comparison: 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.3 Walking velocity (metres per second) at the end of intervention phase.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 1 Independent walking at the end of intervention phase, all electromechanical devices used.
Figures and Tables -
Analysis 1.1

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 1 Independent walking at the end of intervention phase, all electromechanical devices used.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 2 Recovery of independent walking at follow‐up after study end.
Figures and Tables -
Analysis 1.2

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 2 Recovery of independent walking at follow‐up after study end.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 3 Walking velocity (metres per second) at the end of intervention phase.
Figures and Tables -
Analysis 1.3

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 3 Walking velocity (metres per second) at the end of intervention phase.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 4 Walking velocity (metres per second) at follow‐up.
Figures and Tables -
Analysis 1.4

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 4 Walking velocity (metres per second) at follow‐up.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 5 Walking capacity (metres walked in 6 minutes) at the end of intervention phase.
Figures and Tables -
Analysis 1.5

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 5 Walking capacity (metres walked in 6 minutes) at the end of intervention phase.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 6 Walking capacity (metres walked in 6 minutes) at follow‐up.
Figures and Tables -
Analysis 1.6

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 6 Walking capacity (metres walked in 6 minutes) at follow‐up.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 7 Acceptability of electromechanical‐assisted gait training devices during intervention phase: dropouts.
Figures and Tables -
Analysis 1.7

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 7 Acceptability of electromechanical‐assisted gait training devices during intervention phase: dropouts.

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 8 Death from all causes until the end of intervention phase.
Figures and Tables -
Analysis 1.8

Comparison 1 Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 8 Death from all causes until the end of intervention phase.

Comparison 2 Planned sensitivity analysis by trial methodology, Outcome 1 Regaining independent walking ability.
Figures and Tables -
Analysis 2.1

Comparison 2 Planned sensitivity analysis by trial methodology, Outcome 1 Regaining independent walking ability.

Comparison 3 Subgroup analysis comparing participants in acute and chronic phases of stroke, Outcome 1 Independent walking at the end of intervention phase, all electromechanical devices used.
Figures and Tables -
Analysis 3.1

Comparison 3 Subgroup analysis comparing participants in acute and chronic phases of stroke, Outcome 1 Independent walking at the end of intervention phase, all electromechanical devices used.

Comparison 4 Post hoc sensitivity analysis: ambulatory status at study onset, Outcome 1 Recovery of independent walking: ambulatory status at study onset.
Figures and Tables -
Analysis 4.1

Comparison 4 Post hoc sensitivity analysis: ambulatory status at study onset, Outcome 1 Recovery of independent walking: ambulatory status at study onset.

Comparison 4 Post hoc sensitivity analysis: ambulatory status at study onset, Outcome 2 Walking velocity: ambulatory status at study onset.
Figures and Tables -
Analysis 4.2

Comparison 4 Post hoc sensitivity analysis: ambulatory status at study onset, Outcome 2 Walking velocity: ambulatory status at study onset.

Comparison 5 Post hoc sensitivity analysis: type of device, Outcome 1 Different devices for regaining walking ability.
Figures and Tables -
Analysis 5.1

Comparison 5 Post hoc sensitivity analysis: type of device, Outcome 1 Different devices for regaining walking ability.

Comparison 5 Post hoc sensitivity analysis: type of device, Outcome 2 Different devices for regaining walking speed.
Figures and Tables -
Analysis 5.2

Comparison 5 Post hoc sensitivity analysis: type of device, Outcome 2 Different devices for regaining walking speed.

Comparison 5 Post hoc sensitivity analysis: type of device, Outcome 3 Different devices for regaining walking capacity.
Figures and Tables -
Analysis 5.3

Comparison 5 Post hoc sensitivity analysis: type of device, Outcome 3 Different devices for regaining walking capacity.

Summary of findings for the main comparison. Electromechanical‐ and robotic‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke

Electromechanical‐ and robotic‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke

Patient or population: walking after stroke
Setting: inpatient and outpatient setting
Intervention: electromechanical‐ and robotic‐assisted gait training plus physiotherapy
Comparison: physiotherapy (or usual care)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with physiotherapy (or usual care)

Risk with electromechanical‐ and robotic‐assisted gait training plus physiotherapy

Independent walking at the end of intervention phase, all electromechanical devices used
Assessed with FAC

Study population

OR 1.94
(1.39 to 2.71)

1472
(36 RCTs)

⊕⊕⊕⊝
MODERATE 1

457 per 1000

615 per 1000
(530 to 693)

Recovery of independent walking at follow‐up after study end
Assessed with FAC

Study population

OR 1.93
(0.72 to 5.13)

496
(6 RCTs)

⊕⊕⊕⊝
MODERATE 1

551 per 1000

703 per 1000
(469 to 863)

Walking velocity (metres per second) at the end of intervention phase
Assessed with timed measures of gait
Scale: 0 to infinity

The mean walking velocity (metres per second) at the end of intervention phase was 0.

MD 0.04 higher
(0 to 0.09 higher)

985
(24 RCTs)

⊕⊕⊝⊝
LOW 1 2

Walking velocity (metres per second) at follow‐up
Assessed with timed measures of gait
Scale: 0 to infinity

The mean walking velocity (metres per second) at follow‐up was 0.

MD 0.07 higher
(0.05 lower to 0.19 higher)

578
(9 RCTs)

⊕⊕⊕⊝
MODERATE 1

Walking capacity (metres walked in 6 minutes) at the end of intervention phase
Assessed with timed measures of gait
Scale: 0 to infinity

The mean walking capacity (metres walked in 6 minutes) at the end of intervention phase was 0.

MD 5.84 higher
(16.73 lower to 28.40 higher)

594
(12 RCTs)

⊕⊝⊝⊝
VERY LOW 1 3 4

Walking capacity (metres walked in 6 minutes) at follow‐up

The mean walking capacity (metres walked in 6 minutes) at follow‐up was 0.

MD 0.82 lower
(32.17 lower to 30.53 higher)

463
(7 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 4

Acceptability of electromechanical‐assisted gait‐training devices during intervention phase
Assessed with number of dropouts

Study population

OR 0.67
(0.43 to 1.05)

1472
(36 RCTs)

⊕⊕⊝⊝
LOW 1 5

131 per 1000

92 per 1000
(61 to 136)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; FAC: Functional Ambulation Category; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded due to several ratings of 'unclear' and 'high' risk of bias.
2Downgraded due to statistical heterogeneity and no overlap of several confidence intervals.
3Downgraded because the 95% confidence interval includes no effect and the upper confidence limit crosses the minimal important difference.
4Downgraded due to funnel plot asymmetry.
5Downgraded because the total number of events (157) is less than 300 (a threshold rule‐of‐thumb value).

Figures and Tables -
Summary of findings for the main comparison. Electromechanical‐ and robotic‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke
Table 1. Participant characteristics in studies

Study ID

Experimental:

age, mean (SD)

Control:

age, mean (SD)

Experimental:

time poststroke

Control:

time poststroke

Experimental:

sex

Control:

sex

Experimental:

side paresis

Control:

side paresis

Aschbacher 2006

57 years

65 years

≤ 3 months

≤ 3 months

2 female

4 female

Not stated

Not stated

Bang 2016

54 years

54 years

12 months

13 months

5 male, 4 female

4 male, 5 female

4 right, 5 left

4 right, 5 left

Brincks 2011

61 (median) years

59 (median) years

56 (median) days

21 (median) days

5 male, 2 female

4 male, 2 female

5 right, 2 left

1 right, 5 left

Buesing 2015

60 years

62 years

7 years

5 years

17 male, 8 female

16 male, 9 female

13 right, 12 left

12 right, 13 left

Chang 2012

56 (12) years

60 (12) years

16 (5) days

18 (5) days

13 male, 7 female

10 male, 7 female

6 right, 14 left

6 right, 11 left

Cho 2015

55 (12) years

55 (15) years

15 months

13 months

Not stated

Not stated

6 right, 4 left (4 both)

3 right, 1 left (3 both)

Chua 2016

62 (10) years

61 (11) years

27 (11) days

30 (14) days

35 male, 18 female

40 male, 13 female

24 right, 29 left

21 right, 32 left

Dias 2006

70 (7) years

68 (11) years

47 (64) months

48 (30) months

16 male, 4 female

14 male, 6 female

Not stated

Not stated

Fisher 2008

Not stated

Not stated

Less than 12 months

Less than 12 months

Not stated

Not stated

Not stated

Not stated

Forrester 2014

63 years

60 years

12 days

11 days

Not stated

Not stated

9 right, 9 left

7 right, 9 left

Geroin 2011

63 (7) years

61 (6) years

26 (6) months

27 (6) months

14 male, 6 female

9 male, 1 female

Not stated

Not stated

Han 2016

68 (15) years

63 (11) years

22 (8) days

18 (10) days

Not stated

Not stated

20 right, 10 left

14 right, 12 left

Hidler 2009

60 (11) years

55 (9) years

111 (63) days

139 (61) days

21 male, 12 female

18 male, 12 female

22 right, 11 left

13 right, 17 left

Hornby 2008

57 (10) years

57 (11) years

50 (51) months

73 (87) months

15 male, 9 female

15 male, 9 female

16 right, 8 left

16 right, 8 left

Husemann 2007

60 (13) years

57 (11) years

79 (56) days

89 (61) days

11 male, 5 female

10 male, 4 female

12 right, 4 left

11 right, 3 left

Kim 2015

54 (13) years

50 (16) years

80 (60) days

120 (84) days

9 male, 4 female

10 male, 3 female

8 right, 5 left

10 right, 3 left

Kyung 2008

48 (8) years

55 (16) years

22 (23) months

29 (12) months

9 male, 8 female

4 male, 4 female

9 right, 8 left

4 right, 4 left

Mayr 2008

Not stated

Not stated

Between 10 days and 6 months

Between 10 days and 6 months

Not stated

Not stated

Not stated

Not stated

Morone 2011

62 (11) years

62 (14) years

19 (11) days

20 (14) days

15 male, 9 female

13 male, 11 female

13 right, 11 left

15 right, 9 left

Noser 2012

67 (9) years

64 (11) years

1354 days

525 days

7 male, 4 female

6 male, 4 female

Not stated

Not stated

Ochi 2015

62 (8) years

66 (12) years

23 (7) days

26 (8) days

11 male, 2 female

9 male, 4 female

6 right, 7 left

5 right, 8 left

Peurala 2005

52 (8) years

52 (7) years

2.5 (2.5) years

4.0 (5.8) years

26 male, 4 female

11 male, 4 female

13 right, 17 left

10 right, 5 left

Peurala 2009

67 (9) years

68 (10) years

8 (3) days

8 (3) days

11 male, 11 female

18 male, 16 female

11 right, 11 left

14 right, 20 left

Picelli 2016

62 (10) years

65 (3) years

6 (4) years

6 (4) years

7 male, 4 female

9 male, 2 female

Not stated

Not stated

Pohl 2007

62 (12) years

64 (11) years

4.2 (1.8) weeks

4.5 (1.9) weeks

50 male, 27 female

54 male, 24 female

36 right, 41 left

33 right, 45 left

Saltuari 2004

62 (13) years

60 (19) years

3.6 (4.6) months

1.9 (0.8) months

4 male, 4 female

2 male, 6 female

Not stated

Not stated

Schwartz 2006

62 (9) years

65 (8) years

22 (9) days

24 (10) days

21 male, 16 female

20 male, 10 female

17 right, 20 left

8 right, 22 left

Stein 2014

58 (11) years

57 (15) years

49 (39) months

89 (153) months

Not stated

Not stated

Not stated

Not stated

Tanaka 2012

63 (10) years

60 (9) years

55 (37) months

65 (67) months

10 male, 2 female

9 right, 3 left

Tong 2006

71 (14) years

64 (10) years

2.5 (1.2) weeks

2.7 (1.2) weeks

19 male, 11 female

12 male, 8 female

13 right, 17 left

7 right, 13 left

Ucar 2014

56 years

62 years

Not stated

Not stated

Not stated

Not stated

Not stated

Not stated

Van Nunen 2012

53 (10) years

2.1 (1.3) months

16 male, 14 female

Not stated

Not stated

Waldman 2013

51 (8) years

53 (7) years

41 (20) months

30 (22) months

Not stated

Not stated

Not stated

Not stated

Watanabe 2014

67 (17) years

76 (14) years

59 (47) days

51 (34) days

7 male, 4 female

4 male, 7 female

6 right, 5 left

5 right, 6 left

Werner 2002

60 (9) years

60 (9) years

7.4 (2.0) weeks

6.9 (2.1) weeks

8 male, 7 female

5 male, 10 female

8 right, 7 left

8 right, 7 left

Westlake 2009

59 (17) years

55 (14) years

44 (27) months

37 (20) months

6 male, 2 female

7 male, 1 female

4 right, 4 left

3 right, 5 left

SD: standard deviation

Figures and Tables -
Table 1. Participant characteristics in studies
Table 2. Demographics of studies including dropouts and adverse events

Criteria

Stroke severity

Electromechanical device used

Duration of study intervention

Aetiology (ischaemic/haemorrhage)

Intensity of treatment per day

Description of the control intervention

Dropouts

Reasons for dropout

and adverse events in the experimental group

Reasons for dropout and adverse

events in the control group

Source of information

Aschbacher 2006

Not stated

Lokomat

3 weeks

Not stated

30 minutes, 5 times a week

Described as task‐oriented physiotherapy, 5 times a week for 3 weeks (2.5 hours a week)

4 of 23

Not stated

Not stated

Unpublished information in the form of a conference presentation

Bang 2016

Unclear

Lokomat

4 weeks

13/5

60 minutes, 5 times a week (20 sessions)

Described as treadmill training without body weight support

0 of 18

Published information

Brincks 2011

Mean FIM, 92 of 126 points

Lokomat

3 weeks

Not stated

Not stated

Physiotherapy

0 of 13

Unpublished and published information provided by the authors.

Buesing 2015

Unclear

Wearable exoskeleton Stride Management Assist system (SMA)

6 to 8 weeks

Unclear

3 times per week for a maximum of 18 sessions

Functional task‐specific training (intensive overground training and mobility training)

0 of 50

Published information

Chang 2012

Not stated

Lokomat

10 days

Not stated

30 minutes daily for 10 days

Conventional gait training by physical therapists (with equal therapy time and same amount of sessions as experimental group)

3 of 40

Not described by group

(3 participants dropped out:

1 due to aspiration pneumonia, and 2 were unable to co‐operate fully with the experimental procedure)

Unpublished and published information provided by the authors.

Cho 2015

Mean Modified Barthel Index, 36 points

Lokomat

8 weeks (2 phases, cross‐over after 4 weeks)

4/14 (2 both)

30 minutes, 3 times a week for 4 weeks

Bobath (neurophysiological exercises, inhibition of spasticity and synergy pattern)

0 of 20

Published information

Chua 2016

Mean Barthel Index, 49 points

Gait Trainer

8 weeks

Not stated

Not stated

Physiotherapy including 25 minutes of stance/gait, 10 minutes cycling, 10 minutes tilt table standing

20 of 106

2 death, 3 refusal, 1 medical problem, 1 transport problem

(1 pain as adverse event)

1 death, 6 refusal, 3 medical problem, 1 administrative problem

(no adverse events)

Published information

Dias 2006

Mean Barthel Index, 75 points

Gait Trainer

4 weeks

Not stated

40 minutes, 5 times a week

Bobath method, 5 times a week for 5 weeks

0 of 40

Unpublished and published information provided by the authors.

Fisher 2008

Not stated

AutoAmbulator

24 sessions

Not stated

Minimum of 3 sessions a week up to 5 sessions; number of minutes in each session unclear

"Standard" physical therapy, 3 to 5 times a week for 24 consecutive sessions

0 of 20

14 adverse events,

no details provided

11 adverse events,

no details provided

Unpublished and published information provided by the authors.

Forrester 2014

Mean FIM walk 1 point

Anklebot

8 to 10 sessions (with ca. 200 repetitions)

Not stated

60 minutes, 8 to 10 sessions

Stretching of the paretic ankle

5 of 34

Total of 5 dropouts in both groups (1 medical complication, 1 discharge prior study end, 2 time poststroke > 49 days, 1 non‐compliance)

Published information provided by the authors.

Geroin 2011

Mean European Stroke Scale, 80 points

Gait Trainer

2 weeks

Not stated

50 minutes, 5 times a week

Walking exercises according to the Bobath approach

0 of 30

Unpublished and published information provided by the authors.

Han 2016

Not stated

Lokomat

4 weeks

33/23

30 minutes, 5 times a week

Neurodevelopmental techniques for balance and mobility

4 0f 60

4 unclear reasons

Published information provided by the authors.

Hidler 2009

Not stated

Lokomat

8 to 10 weeks (24 sessions)

47/16

45 minutes, 3 days a week

Conventional gait training, 3 times a week for 8 to 10 weeks (24 sessions), each session lasted 1.5 hours

9 of 72

Not described by group

(9 withdrew or were removed because of poor attendance or a decline in health, including 1 death, which according to the authors was unrelated to study)

Unpublished and published information provided by the authors.

Hornby 2008

Not stated

Lokomat

12 sessions

22/26

30 minutes, 12 sessions

Therapist‐assisted gait training, 12 sessions, each session lasted 30 minutes

14 of 62

4 participants dropped out (2 discontinued secondary

to leg pain during training, 1 experienced pitting oedema, and

1 had travel limitations)

10 participants dropped out

(4 discontinued secondary to leg pain, 1 experienced an injury outside therapy, 1 reported fear of

falling during training, 1 presented with significant hypertension,

1 had travel limitations, and

2 experienced

subjective exercise intolerance)

Published information provided by the authors.

Husemann 2007

Median Barthel Index, 35 points

Lokomat

4 weeks

22/8

30 minutes, 5 times a week

Conventional physiotherapy, 30 minutes per day for 4 weeks

2 of 32

1 participant enteritis

1 participant pulmonary embolism

Information as provided by the authors

Kim 2015

Mean Barthel Index, 20 points

Walkbot

4 weeks

13/13

30 minutes, 5 times a week

Conventional physiotherapy (bed mobility, stretching, balance training, strengthening, symmetry training, treadmill training)

4 of 30

1 rib fracture, 3 decline in health condition

Information as provided by the authors

Kyung 2008

Not stated

Lokomat

4 weeks

18/7

45 minutes, 3 days a week

Conventional physiotherapy, received equal time and sessions of conventional gait training

10 of 35

1 participant dropped out for

private reasons (travelling);

adverse events not described

9 participants refused after randomisation (reasons not provided); adverse events not described

Unpublished and published information provided by the authors.

Mayr 2008

Not stated

Lokomat

8 weeks

Not stated

Not stated

Add‐on conventional physiotherapy, received equal time and sessions of conventional gait training

13 of 74

4 participants dropped out (reasons not provided); adverse events not described

9 participants dropped out (reasons not provided)

Unpublished and published information provided by the authors.

Morone 2011

Canadian Neurological Scale, 6 points

Gait Trainer

4 weeks

41/7

40 minutes, 5 times a week

Focused on trunk stabilisation, weight transfer to the paretic leg, and walking between parallel
bars or on the ground. The participant was helped by 1 or 2 therapists and walking aids if necessary.

21 of 48

12 (hypotension, referred weakness, knee pain, urinary infection, uncontrolled blood pressure, fever, absence of physiotherapist)

9 (hypotension, referred weakness, knee pain, ankle pain, uncontrolled blood pressure, fever, absence of physiotherapist)

Information as provided by the authors

Noser 2012

Not stated

Lokomat

Unclear

Not stated

Not stated

Not stated

1 of 21

No dropouts;

2 serious adverse events

(1 skin breakdown as a result of therapy,

1 second stroke during the post‐treatment phase)

1 dropout due to protocol violation;

2 serious adverse events

(1 sudden drop in blood pressure at participant's home leading to brief hospitalisation,

1 sudden chest pain before therapy leading to brief hospitalisation)

Information as provided by the authors

Ochi 2015

Not stated

Gait‐assistance robot (consisting of 4 robotic arms for the thighs and legs, thigh cuffs, leg apparatuses, and a treadmill)

4 weeks

10/16

20 minutes, 5 times a week for 4 weeks, in addition to rehabilitation treatment

Range‐of‐motion exercises, muscle strengthening, rolling over and sit‐to‐stand and activity and gait exercises

0 of 26

Published information

Peurala 2005

Scandinavian Stroke Scale, 42 points

Gait Trainer

3 weeks

25/20

20 minutes, 5 times a week for 3 weeks, in addition to rehabilitation treatment

Walking overground;

all participants practised gait for 15 sessions over 3 weeks (each session lasting 20 minutes)

0 of 45

Published information

Peurala 2009

Not stated

Gait Trainer

3 weeks

42/14

20 minutes, 5 times a week for 3 weeks, in addition to rehabilitation treatment

Overground walking training; in the other control group, 1 or 2 physiotherapy sessions daily but not at the same intensity as in the other groups

9 of 56

5 dropouts

(2 situation worsened after 1 to 2 treatment days;

1 had 2 unsuccessful attempts in device;

1 had scheduling problems;

1 felt protocol too demanding)

4 dropouts

(1 felt protocol too demanding;

2 situation worsened after 1 to 2 treatment days;

1 death)

Published information

Picelli 2016

Not stated

G‐EO System Evolution

Experimental group (G‐EO) 30 minutes a day for 5 consecutive days

Not stated

5 days in addition to botulinum toxin injection of calf muscles

None

0 of 22

Published information

Pohl 2007

Mean Barthel Index, 37 points

Gait Trainer

4 weeks

124/31

20 minutes, 5 times a week

Physiotherapy every weekday for 4 weeks

11 of 155

2 participants refused therapy,

1 increased cranial pressure,

1 relapsing pancreas tumour,

1 cardiovascular unstable

4 participants refused therapy, 1 participant died, 1 myocardial infarction

Published information

Saltuari 2004

Not stated

Lokomat

2 weeks

13/3

A‐B‐A study: in phase A, 30 minutes, 5 days a week

Physiotherapy every weekday for 3 weeks (phase B)

0 of 16

None

None

Unpublished and published information provided by the authors.

Schwartz 2006

Mean NIHSS, 11 points

Lokomat

6 weeks

49/67

30 minutes, 3 times a week

Physiotherapy with additional gait training 3 times a week for 6 weeks

6 of 46

2 participants with leg wounds,

1 participant with recurrent stroke,

1 refused therapy

1 participant with recurrent stroke,

1 with pulmonary embolism

Unpublished and published information provided by the authors.

Stein 2014

Not stated

Bionic leg device (AlterG)

6 weeks

Not stated

1 hour, 3 times a week for 6 weeks

Group exercises

0 of 24

Published information

Tanaka 2012

Mean FIM, 79 points

Gait Master4

4 weeks

Not stated

20 minutes, 2 or 3 times a week (12 sessions)

Non‐intervention (non‐training)

0 of 12

Published information

Tong 2006

Mean Barthel Index, 51 points

Gait Trainer

4 weeks

39/11

20 minutes, 5 times a week

Conventional physiotherapy alone, based on Bobath concept

4 of 50

None

2 participants discharged before study end,

1 participant readmitted to an acute ward,

1 participant deteriorating condition

Published information

Ucar 2014

Not stated

Lokomat

2 weeks

Not stated

30 minutes, 5 times a week

Conventional physiotherapy at home (focused on gait)

0 of 22

Published information

Van Nunen 2012

Not stated

Lokomat

8 weeks

Not stated

30 minutes, twice a week

Overground therapy

0 of 30

Unpublished and published information provided by the author.

Waldman 2013

Not stated

Portable rehab robot (ankle device)

6 weeks

Not stated

3 times a week, 18 sessions

Stretching the plantar flexors and active exercises for ankle mobility and strength

0 of 24

Published information

Watanabe 2014

Not stated

Single‐leg version of the Hybrid Assistive Limb (HAL)

4 weeks

11/11

20 minutes, 12 sessions

Aimed to improve walking speed, endurance, balance, postural stability, and symmetry

10 of 32

4 withdrew,

1 epilepsy,

1 technical reasons

2 pneumonia,

2 discharged

Published information

Werner 2002

Mean Barthel Index, 38 points

Gait Trainer

2 weeks

13/12

20 minutes, 5 times a week

Gait therapy including treadmill training with body weight support

0 of 30

None

None

Published information

Westlake 2009

Not stated

Lokomat

4 weeks (12 sessions)

8/8

30 minutes, 3 times a week

12 physiotherapy sessions including manually guided gait training (3 times a week over 4 weeks)

0 of 16

None

None

Published information

FIM: Functional Independence Measure
NIHSS: National Institutes of Health Stroke Scale

Figures and Tables -
Table 2. Demographics of studies including dropouts and adverse events
Comparison 1. Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Independent walking at the end of intervention phase, all electromechanical devices used Show forest plot

36

1472

Odds Ratio (M‐H, Random, 95% CI)

1.94 [1.39, 2.71]

2 Recovery of independent walking at follow‐up after study end Show forest plot

6

496

Odds Ratio (M‐H, Random, 95% CI)

1.93 [0.72, 5.13]

3 Walking velocity (metres per second) at the end of intervention phase Show forest plot

24

985

Mean Difference (IV, Random, 95% CI)

0.04 [‐0.00, 0.09]

4 Walking velocity (metres per second) at follow‐up Show forest plot

9

578

Mean Difference (IV, Random, 95% CI)

0.07 [‐0.05, 0.19]

5 Walking capacity (metres walked in 6 minutes) at the end of intervention phase Show forest plot

12

594

Mean Difference (IV, Random, 95% CI)

5.84 [‐16.73, 28.40]

6 Walking capacity (metres walked in 6 minutes) at follow‐up Show forest plot

7

463

Mean Difference (IV, Random, 95% CI)

‐0.82 [‐32.17, 30.53]

7 Acceptability of electromechanical‐assisted gait training devices during intervention phase: dropouts Show forest plot

36

1472

Odds Ratio (M‐H, Random, 95% CI)

0.67 [0.43, 1.05]

8 Death from all causes until the end of intervention phase Show forest plot

36

1472

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.02]

Figures and Tables -
Comparison 1. Electromechanical‐ and robotic‐assisted gait training plus physiotherapy versus physiotherapy (or usual care)
Comparison 2. Planned sensitivity analysis by trial methodology

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Regaining independent walking ability Show forest plot

36

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 All studies with adequate sequence generation process

20

949

Odds Ratio (M‐H, Random, 95% CI)

1.80 [1.06, 3.08]

1.2 All studies with adequate concealed allocation

17

831

Odds Ratio (M‐H, Random, 95% CI)

1.87 [1.12, 3.12]

1.3 All studies with blinded assessors for primary outcome

16

762

Odds Ratio (M‐H, Random, 95% CI)

1.81 [1.10, 2.98]

1.4 All studies without incomplete outcome data

14

590

Odds Ratio (M‐H, Random, 95% CI)

2.23 [1.16, 4.29]

1.5 All studies excluding the largest study Pohl 2007

35

1317

Odds Ratio (M‐H, Random, 95% CI)

1.65 [1.17, 2.34]

Figures and Tables -
Comparison 2. Planned sensitivity analysis by trial methodology
Comparison 3. Subgroup analysis comparing participants in acute and chronic phases of stroke

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Independent walking at the end of intervention phase, all electromechanical devices used Show forest plot

36

Odds Ratio (IV, Random, 95% CI)

Subtotals only

1.1 Acute phase: less than or equal to 3 months after stroke

20

1143

Odds Ratio (IV, Random, 95% CI)

1.90 [1.38, 2.63]

1.2 Chronic phase: more than 3 months after stroke

16

461

Odds Ratio (IV, Random, 95% CI)

1.20 [0.40, 3.65]

Figures and Tables -
Comparison 3. Subgroup analysis comparing participants in acute and chronic phases of stroke
Comparison 4. Post hoc sensitivity analysis: ambulatory status at study onset

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recovery of independent walking: ambulatory status at study onset Show forest plot

36

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Studies that included independent walkers

15

500

Odds Ratio (M‐H, Random, 95% CI)

1.38 [0.45, 4.20]

1.2 Studies that included dependent and independent walkers

9

340

Odds Ratio (M‐H, Random, 95% CI)

1.90 [1.11, 3.25]

1.3 Studies that included dependent walkers

12

632

Odds Ratio (M‐H, Random, 95% CI)

1.90 [1.04, 3.48]

2 Walking velocity: ambulatory status at study onset Show forest plot

24

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Studies that included independent walkers

10

317

Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.10, 0.06]

2.2 Studies that included dependent and independent walkers

5

146

Mean Difference (IV, Random, 95% CI)

0.03 [‐0.05, 0.11]

2.3 Studies that included dependent walkers

9

522

Mean Difference (IV, Random, 95% CI)

0.10 [0.03, 0.17]

Figures and Tables -
Comparison 4. Post hoc sensitivity analysis: ambulatory status at study onset
Comparison 5. Post hoc sensitivity analysis: type of device

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Different devices for regaining walking ability Show forest plot

32

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 All studies using end‐effector devices

11

598

Odds Ratio (M‐H, Random, 95% CI)

1.90 [0.99, 3.63]

1.2 All studies using exoskeleton devices

16

585

Odds Ratio (M‐H, Random, 95% CI)

2.05 [1.21, 3.50]

1.3 All studies using mobile devices

3

106

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 All studies using ankle devices

2

63

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2 Different devices for regaining walking speed Show forest plot

24

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 All studies using end‐effector devices

9

519

Mean Difference (IV, Random, 95% CI)

0.11 [0.04, 0.18]

2.2 All studies using exoskeleton devices

12

360

Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.08, 0.04]

2.3 All studies using mobile devices

3

106

Mean Difference (IV, Random, 95% CI)

0.02 [‐0.11, 0.15]

2.4 All studies using ankle devices

1

39

Mean Difference (IV, Random, 95% CI)

0.04 [0.01, 0.07]

3 Different devices for regaining walking capacity Show forest plot

12

594

Mean Difference (IV, Random, 95% CI)

5.84 [‐16.73, 28.40]

3.1 All studies using end‐effector devices

4

328

Mean Difference (IV, Random, 95% CI)

27.50 [3.64, 51.36]

3.2 All studies using exoskeleton devices

5

186

Mean Difference (IV, Random, 95% CI)

‐15.64 [‐46.34, 15.05]

3.3 All studies using mobile devices

2

56

Mean Difference (IV, Random, 95% CI)

20.06 [‐39.52, 79.63]

3.4 All studies using ankle devices

1

24

Mean Difference (IV, Random, 95% CI)

8.0 [‐83.03, 99.03]

Figures and Tables -
Comparison 5. Post hoc sensitivity analysis: type of device