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Sponsors and Collaborators: |
St George's, University of London The Health Foundation |
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Information provided by: | St George's, University of London |
ClinicalTrials.gov Identifier: | NCT00322192 |
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 | Intervention | Phase |
---|---|---|
Stroke |
Behavioral: Conventional UK Physical therapy Behavioral: Increased intensity of UK conventional physical therapy Behavioral: UK conventional physical therapy plus functional strength training |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke |
Estimated Enrollment: | 300 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects in this study will:
In addition those who agree to participate in TMS measurement will have no contraindications to TMS.
Contact: Valerie M Pomeroy, PhD | +44(0)20 8725 5327 | v.pomeroy@sgul.ac.uk |
United Kingdom | |
St George's Hospital NHS Trust | Recruiting |
London, United Kingdom, SW17 0RE | |
Principal Investigator: Valerie M Pomeroy, PhD | |
Sub-Investigator: Emma V Cooke, MSc | |
United Kingdom, Surrey | |
Epsom and St Helier NHS Trust | Recruiting |
Carshalton, Surrey, United Kingdom, SM5 1AA | |
Principal Investigator: Valerie M Pomeroy, PhD | |
Sub-Investigator: Emma V Cooke, MSc | |
Mayday University Hospital NHS Trust | Active, not recruiting |
Thornton Heath, Surrey, United Kingdom, CR7 7YE | |
Ashford and St Peter's Hospitals NHS Trust | Recruiting |
Chertsey, Surrey, United Kingdom, KT16 0PZ | |
Principal Investigator: Valerie M Pomeroy, PhD | |
Sub-Investigator: Emma V Cooke, MSc |
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, UK |
Study ID Numbers: | Health Foundation 224/1960, Health Foundation 224/1960 |
Study First Received: | May 4, 2006 |
Last Updated: | May 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00322192 |
Health Authority: | United Kingdom: Research Ethics Committee |
Stroke rehabilitation Physical Therapy |
Cerebral Infarction Asthenia Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |