Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke
Study Details
Study Description
Brief Summary
The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.
An observer-blind randomised clinical trial. Subjects will be within 3 months of first stroke with some voluntary movement in the paretic lower limb. A power calculation estimated the sample size as 300. Research Physiotherapists, blinded to measurement, will recruit subjects, allocate subjects to one of the three intervention groups using sequentially numbered sealed envelopes containing previously randomised allocated intervention cards and provide interventions. The Research Assessors, blinded to intervention allocation will undertake all measurements. Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1) or functional strength training (experimental 2) will be provided for one hour, four times a week, for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting. Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are maximum torque around the knee joint, and gait velocity. The secondary outcomes include movement analysis, functional ability, corticospinal transmission (transcranial magnetic stimulation) and health related quality of life (Euroqol). The primary analysis will be analysis of covariance. A multiple comparison procedure (Gabriel's test) will be used to compare each pair of treatments. Euroqol data will be used to estimate the relative costs of the interventions and to calculate the incremental cost per QUALY gained. Every effort will be made to invite patients for assessment at outcome and follow-up even if they have withdrawn from therapy to allow the intention-to-treat principle to be applied.
Study Design
Outcome Measures
Primary Outcome Measures
- Maximum torque around the knee joint []
- gait velocity []
Secondary Outcome Measures
- Modified Rivermead Mobility Index []
- Lower limb kinematics during standing up []
- Lower limb kinematics during sitting down []
- Lower limb kinematics during walking []
- timing and pattern of muscle activation during functional activity []
- EuroQuol for health related quality of life []
- Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS []
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects in this study will:
-
be aged over 50 years.
-
be between one week and three months after stroke when recruited to the study;
-
have been independently mobile indoors, with or without aids, before the stroke;
-
have some voluntary movement in the paretic lower limb i.e. score above 28/100 on the lower limb section of the Motricity Index43;
-
demonstrate adequate orientation and communication (be able to complete a one-stage command using the non-paretic upper limb e.g. point at the ceiling).
In addition those who agree to participate in TMS measurement will have no contraindications to TMS.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Epsom and St Helier NHS Trust | Carshalton | Surrey | United Kingdom | SM5 1AA |
| 2 | Ashford and St Peter's Hospitals NHS Trust | Chertsey | Surrey | United Kingdom | KT16 0PZ |
| 3 | Mayday University Hospital NHS Trust | Thornton Heath | Surrey | United Kingdom | CR7 7YE |
| 4 | St George's Hospital NHS Trust | London | United Kingdom | SW17 0RE |
Sponsors and Collaborators
- St George's, University of London
- The Health Foundation
Investigators
- Study Chair: Valerie M Pomeroy, PhD, St George's University London, UK
- Principal Investigator: Emma V Cooke, MSc, St George's University London, UK
- Study Director: Raymond C Tallis, FMedSci, University of Manchester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Health Foundation 224/1960
- Health Foundation 224/1960