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Cochrane Database of Systematic Reviews Protocol - Intervention

Telerehabilitation services for stroke

Authors' declarations of interest

Version published: 12 December 2012 Version history

https://doi.org/10.1002/14651858.CD010255

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view the current version 31 January 2020
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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The primary objective of this review is to determine:

  1. whether the use of telerehabilitation leads to improved ability to perform activities of daily living among stroke survivors when compared with in‐person rehabilitation. In‐person rehabilitation occurs when the clinician and patient are at the same physical location and rehabilitation is provided face‐to‐face either in an inpatient, clinic or home setting;

  2. whether the use of telerehabilitation leads to improved ability to perform activities of daily living among stroke survivors when compared with no rehabilitation.

The secondary objective is to determine whether use of telerehabilitation leads to greater independence in self‐care and domestic life, mobility, health‐related quality of life, upper limb function, cognitive function or functional communication when compared with in‐person rehabilitation and no rehabilitation. Additionally, we aim to report on the presence of adverse events, cost‐effectiveness, feasibility and levels of user satisfaction with the intervention.

Background

Description of the condition

Stroke is one of the most common causes of death and acquired disability worldwide (Donnan 2008). Survivors of stroke commonly experience a range of symptoms affecting motor function, speech, swallowing, vision, sensation and cognition and recovery can be slow and incomplete (Langhorne 2011). Approximately half of stroke survivors access some form of rehabilitation on discharge from acute services (National Stroke Foundation 2011; National Institutes of Health 2012). Rehabilitation programs are often lengthy and resource intensive (AROC 2011; Canadian Stroke Network 2011). Therefore, determining the most effective and efficient ways to deliver stroke rehabilitation services is a priority (Langhorne 2002). 

Description of the intervention

Telerehabilitation is the provision of rehabilitation services to patients at a remote location using information and communication technologies (Brennan 2009). Communication between the client and the rehabilitation professional may occur using a variety of technologies such as the telephone, Internet‐based video conferencing, sensors and virtual reality programs (Rogante 2010). Telerehabilitation consultations may include assessment, diagnosis, goal setting, therapy, education and monitoring (Russell 2009).

Stemming from the broader approach of telehealth, telerehabilitation has been described as an alternative method of delivering conventional rehabilitation services rather than a subspecialty (Winters 2002). The approach is relatively new with the first related literature published in the late 1990s. Increasing interest in the use of telerehabilitation (Brochard 2010) has prompted professional bodies to draft position statements regarding its use (American Speech‐Language‐Hearing Association 2005; Wakeford 2005). These statements have emphasised the need to ensure that quality, ethical and legal standards are met when treatment is provided remotely rather than in person.

There are now many examples in the literature that demonstrate the scope of telerehabilitation. For example, home assessments to determine the need for modifications were completed remotely by occupational therapists using a combination of still photography, telephone calls and videoconferencing technology (Sanford 2004). Physiotherapists provided a safe and effective therapy program for people following total knee replacement using videoconferencing (Russell 2004) and speech pathologists have demonstrated the feasibility of assessing motor speech disorders via the Internet (Hill 2006).

How the intervention might work

Telerehabilitaton has been described simply as an alternative method of providing rehabilitation. Therefore, in theory, the mechanisms leading to recovery should mirror those associated with conventional rehabilitation programs. It is now well established that organised, interdisciplinary stroke care reduces the likelihood of institutional care and long‐term disability and increases independence in activities of daily living (Kalra 2007). Improvements in function following rehabilitation programs have been attributed to a combination of physiological recovery, neuroplasticity and compensation (Kwakkel 2004).

One of the key advantages of telerehabilitation is that it provides the opportunity for people who are isolated to access rehabilitation services. This feature is particularly beneficial in vast countries such as Canada and Australia where a significant proportion of the population live at a distance from nearby specialised rehabilitation centres. People in rural and remote areas are unlikely to have access to rehabilitation teams with expertise in stroke, and may not have access to rehabilitation clinicians at all. Eliminating the need for travel may also benefit people with severely restricted mobility who have difficulty or are unable to travel to rehabilitation centres.

Telerehabilitation services may also be used to complement and enhance the quality of current rehabilitation services. Stroke survivors have expressed concerns regarding the lack of long‐term support available and ongoing unmet rehabilitation needs (McKevitt 2011). It is possible that the use of telerehabilitation may help to address these gaps by supporting patients to resume life roles on discharge from inpatient facilities.

Furthermore, there are ways in which the use of telerehabilitation may result in cost savings. Reduced travel time (for clinicians who visit patients in their own home) may mean that clinicians are able to fit more consultations into one day. In addition, it may be possible to discharge patients from inpatient rehabilitation facilities earlier and offer telerehabilitation as a way of continuing the rehabilitation program.  

Despite its apparent advantages, the challenges associated with telerehabilitation are well documented (Theodoros 2008). One of the key issues facing clinicians is how to conduct assessments or provide interventions that are typically "hands on", for example, the assessment of muscle strength. The inability to conduct hands‐on assessment or treatment means that therapists need to modify current techniques, for example utilising family members or teaching the client ways to perform the intervention independently (Russell 2009).

Furthermore, clinicians and patients may not possess the technical expertise to establish systems and troubleshoot information and communication technologies. It has been recommended that service providers ensure that technical requirements are met (such as having adequate bandwidth), provide access to technical support and provide training to all users (clinicians and patients). Concerns have also been raised about the security of data transfer and how to maintain patient confidentiality (American Telemedicine Association 2010).

Why it is important to do this review

Changes in the demographics of the population mean that the burden of stroke is projected to increase (Feigin 2003). New approaches that are demonstrated to be clinically and cost effective will be required. Increasing interest in telerehabilitation suggests that this area will continue to grow (Brochard 2010). Furthermore, clinical guidelines for stroke now recommend telerehabilitation for people without access to centre‐based rehabilitation services (Canadian Stroke Network 2006). However, the establishment of telerehabilitation services may be expensive due to the costs of the equipment, training and ongoing technical support. It is therefore important to determine whether establishment of telerehabilitation services may result in the desired outcomes.

Previous systematic reviews have examined the effectiveness of telerehabilitation after stroke (Kairy 2009; Johansson 2011). Kairy et al reviewed the evidence for telerehabilitation for a range of diagnostic groups (Kairy 2009). The literature search was completed in 2007 and included both experimental and observational studies. Four studies involving patients with stroke were included, all of which were observational. The authors reported that despite some studies reporting positive effects, more research was required to provide definitive information. A more recent review looked specifically at telerehabilitation following stroke and identified nine relevant studies, of which four were randomised controlled trials (Johansson 2011). Once again, the authors reported that while the approach showed promise and was associated with high levels of patient satisfaction, there was insufficient evidence to guide practice and there was no evidence regarding the cost‐effectiveness of telerehabilitation. There were several limitations associated with these reviews including limited search terms and sources. Given the potential of telerehabilitation to improve access and quality of rehabilitation services and reduce costs, a review using Cochrane methodology appears warranted.  

Objectives

The primary objective of this review is to determine:

  1. whether the use of telerehabilitation leads to improved ability to perform activities of daily living among stroke survivors when compared with in‐person rehabilitation. In‐person rehabilitation occurs when the clinician and patient are at the same physical location and rehabilitation is provided face‐to‐face either in an inpatient, clinic or home setting;

  2. whether the use of telerehabilitation leads to improved ability to perform activities of daily living among stroke survivors when compared with no rehabilitation.

The secondary objective is to determine whether use of telerehabilitation leads to greater independence in self‐care and domestic life, mobility, health‐related quality of life, upper limb function, cognitive function or functional communication when compared with in‐person rehabilitation and no rehabilitation. Additionally, we aim to report on the presence of adverse events, cost‐effectiveness, feasibility and levels of user satisfaction with the intervention.

Methods

Criteria for considering studies for this review

Types of studies

We will only include randomised controlled trials (RCTs). We will consider cross‐over trials as RCTs according to The Cochrane Collaboration's guidelines (Higgins 2011). Studies will compare telerehabilitation with in‐person rehabilitation or no rehabilitation. We will provide a narrative description of studies that compare two different methods of delivering telerehabilitation services without an alternative group. In addition, where possible, we will compare studies where different doses of telerehabilitation are evaluated. We will include studies that use telerehabilitation plus usual care compared with usual care alone.

Types of participants

All study participants will have a clinical diagnosis of stroke as defined by the World Health Organization (a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin) (WHO 1989). We will include people with all types of stroke, at all levels of severity and at all stages post stroke (acute, subacute or chronic). We will also include patients with subarachnoid haemorrhage. We will exclude studies with participants of mixed aetiology (for example, stroke and traumatic brain injury) unless data are available for stroke survivors only. No age limits will be set; however, we will acknowledge the inclusion of any participants who are younger than 18 years.

Types of interventions

We will include Interventions if they match the following definition of telerehabilitation: "the delivery of rehabilitation services via information and communication technologies" (Brennan 2009). Clinically, this term encompasses a range of rehabilitation services that include assessment, prevention, intervention, supervision, education, consultation and counselling (American Telemedicine Association 2010). Programs must last for more than one session. Interactive and communication technologies may include the telephone, Internet, virtual reality, monitoring via sensors or wearable devices and virtual reality programs. We will include rehabilitation programs that use either "store and forward" methods of communication, or real‐time interaction. Interventions may be provided by one or more health disciplines (for example, we will include studies involving only speech therapy). We will include rehabilitation programs that use a combination of telerehabilitation and in‐person rehabilitation to conduct assessment or intervention provided that the greater proportion of intervention is provided via telerehabilitation. We will not include the use of telerehabilitation where the purpose is to provide education or support for health professionals rather than patient care. We will include studies comparing telerehabilitation with no intervention or an alternative intervention.

Types of outcome measures

Primary outcomes

The primary outcome of interest is independence in activities of daily living. In the review, this will encompass the self‐care, mobility and domestic life activity and participation domains from the International Classification of Functioning, Disability and Health (WHO 2010). This may include assessment tools scored by the health professional such as the Functional Independence Measure or Barthel Index or questionnaires completed by the study participant (for example, the Nottingham Extended Activities of Daily Living Index).

Secondary outcomes

  1. Self‐care and domestic life

  2. Mobility (for example, Timed Up and Go test, walking speed, functional ambulation category)

  3. Patient satisfaction with the intervention

  4. Self‐reported health‐related quality of life  

  5. Upper limb function (for example, Action Research Arm Test, Wolf Motor Function Test, Fugl‐Meyer Upper Extremity measure)  

  6. Cognitive function (global measures such as the Mini Mental State Examination, or specific measures such as tests of attention or executive functioning)

  7. Functional communication

  8. Cost‐effectiveness (as measured by comparing the costs and outcomes of each intervention approach)

  9. Adverse events

We will only pool outcome measures in meta‐analyses if they are clinically comparable. For example, we will combine different measures of mobility.  

We will also comment on the feasibility of telerehabilitation for use with stroke patients by reporting on participant eligibility criteria and recruitment methods from the individual studies.

Search methods for identification of studies

See the 'Specialized register' section in the Cochrane Stroke Group module. We will search for relevant trials in all languages and arrange translation of trial reports published in languages other than English.

Electronic searches

We will search the Cochrane Stroke Group Trials Register and the Cochrane Effective Practice and Organisation of Care (EPOC) Group Trials Register. In addition, we will search the following electronic bibliographic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, latest issue), MEDLINE (1950 to present) (Appendix 1), EMBASE (1980 to present), AMED (1985 to present), CINAHL (1982 to present), PsycINFO (1840 to present), PsycBITE (Psychological Database for Brain Impairment Treatment Efficacy, www.psycbite.com/), OTseeker (www.otseeker.com), Physiotherapy Evidence Database (www.pedro.org.au), REHABDATA (www.naric.com/research/rehab/), and Health Technology Assessment Database (HTA) (www.crd.york.ac.uk/crdweb/). We developed the MEDLINE search strategy with the help of the Cochrane Stroke Group Trials Search Co‐ordinator and have used a combination of controlled vocabulary and text word terms. We will adapt this strategy for the other databases.

To identify further published, unpublished and ongoing trials, we will:

  1. search the following ongoing trials registers: Current Controlled Trials (www.controlled‐trials.com), National Institute of Health Clinical Trials Database (www.clinicaltrials.gov), Stroke Trials Registry (www.strokecenter.org/trials/), EU Clinical Trials Register (www.clinicaltrialsregister.eu), WHO International Clinical Trials Registry Platform (www.who.int/ictrp/en/), Australian New Zealand Clinical Trials Registry (www.anzctr.org.au/);

  2. use the Cited Reference Search within Science Citation Index (SCI) and Social Science Citation Index (SSCI) to track relevant references;

  3. scan the reference lists of all identified studies and reviews;

  4. search Dissertation Abstracts and contact the key researchers in the area and international telemedicine organisations;

  5. search the UK Telemedicine and E‐health Information Service (www.teis.port.ac.uk/);

  6. scan the abstracts of non‐English language studies if they are available in English;

  7. search the proceedings of the American Telemedicine Association International Meetings and International Congress on Telehealth and Telecare;

  8. search the grey literature using Open Grey (www.opengrey.eu) and Google Scholar (http://scholar.google.com).

Data collection and analysis

Selection of studies

Two review authors (KL and DS) will independently review titles and abstracts of the records identified from the electronic searches and exclude obviously irrelevant studies. We will obtain the full text of the remaining studies and two review authors (KL and SG) will select studies for inclusion based on the inclusion criteria of the review. If these authors are unsure regarding the inclusion of a particular study a third review author (MC) will make the final decision. We will contact trial authors for further details when required. We will document the reasons for exclusion.

Data extraction and management

Two review authors will independently extract study data and record information on a pre‐designed data extraction form. We will extract the following study details:

  1. citation details: title, authors, source and year of publication;

  2. participant inclusion and exclusion criteria;

  3. participant details: age, gender, location of stroke, time since onset of stroke, level of disability;

  4. recruitment details: number of people screened, eligible, recruited and randomised, withdrawals;

  5. methodological quality: we will use The Cochrane Collaboration's tool for assessing risk of bias;

  6. intervention details: description of procedures, personnel involved, duration, dose, comparison intervention;

  7. outcome measures: measures used, by whom and when they were administered, how they were administered (in person or via information and communication technologies).

We will contact trial authors for missing information where required. We will resolve differences by discussion or a third review author if necessary.

Assessment of risk of bias in included studies

Two review authors will independently assess the risk of bias of included studies using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). The tool comprises assessment of the following possible sources of bias: random sequence generation; allocation concealment; blinding of participants, personnel and outcome assessors; incomplete outcome data; selective reporting; and any other potential sources of bias. We will compare each study against the tool and assess it as "low risk", "high risk" or "unclear risk" of bias depending on whether they meet the criteria for each aspect of the tool. A third review author will resolve any disagreements.   

Measures of treatment effect

Two review authors will independently assign outcome measures to the domain assessed (activities of daily living, participant satisfaction, health‐related quality of life, mobility, upper limb function, cognitive function, functional communication). If more than one outcome measure is used in the same domain from the same study, we will include the measure most frequently used across included studies.

If possible, we will conduct separate analyses between short‐term (less than three months after intervention) and long‐term (three months or more) outcomes.

We will calculate risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes. We will calculate mean differences (MD) or standardised mean differences (SMD) and 95% CI for continuous outcomes as appropriate.  

Unit of analysis issues

The unit of randomisation in these trials is the individual patient. For three‐armed trials in which telerehabilitation is compared with in‐person or no rehabilitation, we will enter half the sample size for the telerehabilitation group. Thus, each alternative intervention will be included in a separate comparison and the number of participants in the telerehabilitation group will be divided equally between the comparisons; the telerehabilitation group mean and standard deviation will remain unchanged.

Dealing with missing data

We will contact trial authors for missing data. We will convert available data where possible (for example, when data are reported as standard error) using the procedures detailed in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will conduct intention‐to‐treat analyses where possible as recommended by the Cochrane Handbook for Systematic Reviews of Interventions. Where drop‐outs are clearly identified, we will use the denominator of participants contributing data at the relevant outcome assessment.

Assessment of heterogeneity

We will pool results to present an overall estimate of the treatment effect using a random‐effects model. We will assess heterogeneity by visual inspection of the forest plot along with consideration of the Chi2 test for heterogeneity and the I2 statistic (Higgins 2011).

Assessment of reporting biases

We will reduce the impact of publication bias by searching clinical trial registers for studies. In addition, we will investigate whether selective reporting has occurred by comparing study protocols and the methods section of papers with the results. If there are sufficient data, we will attempt to assess small sample bias by preparing a funnel plot.

Data synthesis

We will conduct a meta‐analysis using a random‐effects model with 95% CI using RevMan 5.1 (RevMan 2011). We will explore heterogeneity as detailed below.

Subgroup analysis and investigation of heterogeneity

If there are a sufficient number of comparable studies (four or more), we will perform subgroup analyses to determine whether outcomes vary according to time since onset of stroke, severity of stroke, the frequency of intervention (occasions of service per week), the intensity of intervention (total hours of intervention), the intervention approach (for example, speech therapy or upper limb retraining), the mode of delivery (for example, telephone versus video conferencing and real‐time communication versus "store and forward") and whether the intervention is provided by a multidisciplinary team or by one discipline.

Sensitivity analysis

We will perform sensitivity analyses based on the methodological quality of studies (allocation concealment, blinding of outcome assessor, intention‐to‐treat analysis) to assess the impact of risk of bias in the included studies. We will also conduct a sensitivity analysis to determine differences between using a fixed‐effect and random‐effects model.