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Entrenamiento asistido por aparatos electromecánicos para caminar después de un accidente cerebrovascular

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DOI:
https://doi.org/10.1002/14651858.CD006185.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 10 mayo 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Accidentes cerebrovasculares

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Jan Mehrholz

    Correspondencia a: Department of Public Health, Dresden Medical School, Technical University Dresden, Dresden, Germany

    [email protected]

    [email protected]

  • Simone Thomas

    Wissenschaftliches Institut, Klinik Bavaria Kreischa, Kreischa, Germany

  • Cordula Werner

    Medicalpark, Schlaganfallzentrum Berlin, 13507 Berlin ‐ Tegel, Germany

  • Joachim Kugler

    Department of Public Health, Dresden Medical School, Technical University Dresden, Dresden, Germany

  • Marcus Pohl

    Neurological Rehabilitation, Helios Klinik Schloss Pulsnitz, Pulsnitz, Germany

  • Bernhard Elsner

    Department of Public Health, Dresden Medical School, Technical University Dresden, Dresden, Germany

Contributions of authors

Jan Mehrholz (JM) contributed to the conception and the design of the protocol and drafted the protocol. He searched electronic databases and conference proceedings, screened titles and abstracts of references identified by the search, selected and assessed trials, extracted trial and outcome data, guided the analysis and interpretation of data, and contributed to and approved the final manuscript of the review.

Simone Thomas (ST) evaluated and extracted trial data, assessed the methodological quality of selected trials, contributed to the interpretation of data, and contributed to and approved the final manuscript of the review.

Cordula Werner (CW) screened the titles and abstracts of references identified by the search; located, selected, and assessed trials; extracted trial and outcome data; assessed the methodological quality of selected trials; contributed to the interpretation of data; and contributed to and approved the final manuscript of the review.

Joachim Kugler (JK) evaluated and extracted trial and outcome data, assessed the methodological quality of selected trials, contributed to the interpretation of data, and contributed to and approved the final manuscript of the review.

Marcus Pohl (MP) contributed to the conception and design of the review, drafted the protocol, and assessed the methodological quality of selected trials. Together with JM, he contacted trialists about unpublished data and entered the data, carried out statistical analysis, helped with the interpretation of the data, drafted the review, and approved the final manuscript of the review.

Bernhard Elsner (BE) searched electronic databases and conference proceedings, screened titles and abstracts of references identified by the search, selected and assessed trials, guided analysis and the interpretation of the data, and contributed to and approved the final manuscript of the review.

Sources of support

Internal sources

  • Klinik Bavaria Kreischa, Wissenschaftliches Institut, Germany.

  • Technical University Dresden, Lehrstuhl Public Health, Germany.

  • SRH Fachhochschule Gera, Lehrstuhl Therapiewissenschaften, Germany.

External sources

  • No sources of support supplied

Declarations of interest

Bernhard Elsner: none known.

Simone Thomas: none known.

Joachim Kugler: none known.

Marcus Pohl was author of one included trial (Pohl 2007).

Jan Mehrholz was co‐author of one included trial (Pohl 2007).

Cordula Werner was an author of two included trials (Pohl 2007; Werner 2002), and of one excluded trial (Hesse 2001).

These review authors (MP, JM, CW) did not participate in quality assessment and data extraction of these studies.

Acknowledgements

We thank Brenda Thomas for help with developing the search strategy and for providing us with relevant trials and systematic reviews from CINAHL, AMED, SPORTDiscus, and Inspec; Hazel Fraser for providing us with relevant information about trials and systematic reviews from the Cochrane Stroke Group Trials Register; and Gabi Voigt for conducting research and for providing us with many helpful studies. We thank Stanley Fisher, Carmen Krewer, Jorge Lians, Andreas Mayer, Stefan Hesse, Joseph Hidler, George Hornby, Yun‐Hee Kim, Zeev Meiner, Sinnika Peurala, Leopold Saltuari, Isabella Schwartz, Raymond Tong, John Brincks, Michael van Nunen, and Naoki Tanaka for providing additional information or unpublished data for their trials.

Version history

Published

Title

Stage

Authors

Version

2020 Oct 22

Electromechanical‐assisted training for walking after stroke

Review

Jan Mehrholz, Simone Thomas, Joachim Kugler, Marcus Pohl, Bernhard Elsner

https://doi.org/10.1002/14651858.CD006185.pub5

2017 May 10

Electromechanical‐assisted training for walking after stroke

Review

Jan Mehrholz, Simone Thomas, Cordula Werner, Joachim Kugler, Marcus Pohl, Bernhard Elsner

https://doi.org/10.1002/14651858.CD006185.pub4

2013 Jul 25

Electromechanical‐assisted training for walking after stroke

Review

Jan Mehrholz, Bernhard Elsner, Cordula Werner, Joachim Kugler, Marcus Pohl

https://doi.org/10.1002/14651858.CD006185.pub3

2007 Oct 17

Electromechanical‐assisted training for walking after stroke

Review

Jan Mehrholz, Cordula Werner, Joachim Kugler, Marcus Pohl

https://doi.org/10.1002/14651858.CD006185.pub2

2006 Oct 18

Electromechanical‐assisted training for walking after stroke

Protocol

Jan Mehrholz, Cordula Werner, Joachim Kugler, Marcus Pohl

https://doi.org/10.1002/14651858.CD006185

Differences between protocol and review

In our protocol we stated that we would use the PEDro Scale to assess the methodological quality of the included trials. However, Chapter 8 of the latest edition of the Cochrane Handbook for Systematic Reviews of Interventions suggests that scales that yield a summary score should be avoided (Higgins 2011a). In accordance with this suggestion, we no longer used the PEDro Scale to assess the methodological quality of the included trials, instead using the Cochrane 'Risk of bias' tool to analyse trial methodology.

In our protocol we planned to quantify heterogeneity with the I² statistic and to use a cutoff of I² = 50% for all comparisons. Additonally, we planned to calculate the overall effects using a random‐effects model instead of a fixed‐effect model when we found substantial heterogeneity. However, in this update we calculated the overall effects using a random‐effects model, irrespective of the level of heterogeneity.

In this review update we expanded our post‐hoc sensitivity analysis: type of device (Analysis 5.1; Analysis 5.2; Analysis 5.3) by introducing a new subgroup of studies using mobile and ankle devices and adding a new comparison in Analysis 5 (Analysis 5.3 Different devices for regaining walking capacity).

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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.
Figuras y tablas -
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).

Figuras y tablas -
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

Figuras y tablas -
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

Figuras y tablas -
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]

Figuras y tablas -
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]

Figuras y tablas -
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]

Figuras y tablas -
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]

Figuras y tablas -
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]

Figuras y tablas -
Comparison 5. Post hoc sensitivity analysis: type of device