Does functional electrical stimulation improve activity and participation after stroke?
Six electronic databases will be searched with pre-determined search terms. Data bases will be the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), CINHAL (EBESCO), EMBASE (Ovid), the Physiotherapy Evidence Database (PEDRO), and Occupational Therapy Systematic Evaluation of Effectiveness database (OTseeker).
Reference list of eligible studies, will be examined to identify potential studies that were not identified through the initial search process. There will be no language restrictions.
This review will include randomised controlled trials and quasi randomised controlled trials.
Condition or domain being studied
Survivors of stroke.
Population will include adults of age 18 plus. Only human subjects will be included. 80% of participants in studies will have had a stroke, and the remaining 20% of participants will have a stroke like condition.
The intervention of interest is functional electrical stimulation. Functional electrical stimulation for this review is defined as electrical stimulation that is applied during a task to improve the performance of that task.
Criteria established to define functional electric stimulation for this review:
• The stimulator must be external to the body with electrodes placed onto the skin.
• The stimulation must produce a muscle contraction that causes movement to either upper or lower limb
• Subject will have active involvement with a therapeutic task whilst device is activated.
• The intervention must include the practice of task or activities (eg, walking, standing up, reaching for or the manipulation of items) for the majority of the intervention rather than the practice of isolated movements.
Studies that use a mix of interventions within the study design will be allowed, however, functional electrical stimulation must be the primary therapeutic intervention. Studies will be excluded if the functional electrical stimulation is used only as an orthosis.
Studies will be included if the intervention group is compared with another group such as placebo, usual care or an alternative therapy. Studies will not be included if the comparison group is predominantly another functional electrical stimulation based protocol.
Primary outcomes will be measures that reflect the domains of activity or participation of the international classification of functioning.
Data extraction, (selection and coding)
1. Author will screen eligibility based on title and abstract using predetermined criteria. All obviously ineligible studies will be immediately excluded. For all the remaining studies, full text, will be retrieved. Reports regarding the same study will be linked together to ensure that the data from that study, will only be included once in review and analysis.
2. Authors will then review eligibility of these full texts. Authors of studies may be contacted to collect any relevant missing data or clarify details of the study to ensure inclusion of study. If a disagreement regarding inclusion of a study into the review occurs, this will be resolved by the two authors reviewing eligibility, to discuss the issue. If not resolved, a third party will be involved in the discussion. If still not resolved, the author of the study in question will be contacted in an attempt to resolve disagreement. If still not resolved, the disagreement will be noted in the review. Authors reviewing inclusion criteria will not be masked to the study details, i.e. author, data or institution.
Data Extraction will be carried out by two review authors independently. Data will be collected from the eligible studies by using a predetermined data collection form and risk of bias tool. This data extraction form will record information regarding study, participants, interventions, outcome measures, continuous and dichotomous data, missing data that requires follow up and miscellaneous data of importance to this review such as funding sources.
Risk of bias (quality) assessment
One author will assess the risk of bias of each study, using the PEDro scale scores from the physiotherapy Evidence Database (www.pedro.org.au). If no score is available, the scale score will be calculated by two people independently. If disagreement occurs, discussion will occur to reach agreement. All studies that meet the eligibility criteria, irrespective of level of quality, will be included into this review. However, only studies determined to be of quality of a PEDro score greater than 4, will be eligible to be included in the meta-analysis.
Strategy for data synthesis
Data will be entered into REVMAN software.
Treatment effect for continuous data will be calculated using one of two methods.
1. If the same outcome measures are used, we will calculate mean difference and 95% CI.
2. If different outcome measures are used, we will calculate standardised mean difference and 95% CI.
Treatment effect for dichotomous data will be calculated using risk difference and 95% CI.
Heterogeneity will be examined by visual inspection of forest plot, Chi-squared test and I-squared statistic. Sensitivity analysis will occur after the initial meta-analyses are completed. If more than 10 studies are included in the meta-analysis, a funnel plot test will occur to determine if small studies had an effect on the overall outcome.
Analysis of subgroups or subsets
Sub group analysis may occur on following groups if sufficient data available:
1. Upper limb as compared to lower limb outcomes.
2. Number of days after stroke.
3. Number of muscles stimulated by the functional electrical stimulation.
Systematic review will be published in a peer reviewed journal. Presentation of work will occur at scientific conferences.
Contact details for further information
Outpatient Rehabilitation Services
PO Box 126
Organisational affiliation of the review
Latrobe University, Bendigo Health, Alfred Health, University of Sydney
Mr Owen Howlett, Latrobe University and Bendigo Health Dr Natasha Lannin, Latrobe University and Alfred Health Dr Louise Ada, University of Sydney Dr Carol McKinstry, Latrobe University
Anticipated or actual start date
08 October 2012
Anticipated completion date
08 October 2013
Conflicts of interest
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Electric Stimulation Therapy; Gait Disorders, Neurologic; Humans; Stroke; Walking
Date of registration in PROSPERO
10 October 2012
Date of publication of this revision
10 October 2012
Stage of review at time of this submission
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.