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Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322192
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : June 10, 2015
The Health Foundation
Information provided by:
St George's, University of London

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
Stroke Behavioral: Conventional UK Physical therapy Behavioral: Increased intensity of UK conventional physical therapy Behavioral: UK conventional physical therapy plus functional strength training 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke
Study Start Date : January 2004
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  1. Maximum torque around the knee joint
  2. gait velocity

Secondary Outcome Measures :
  1. Modified Rivermead Mobility Index
  2. Lower limb kinematics during standing up
  3. Lower limb kinematics during sitting down
  4. Lower limb kinematics during walking
  5. timing and pattern of muscle activation during functional activity
  6. EuroQuol for health related quality of life
  7. Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322192

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United Kingdom
Epsom and St Helier NHS Trust
Carshalton, Surrey, United Kingdom, SM5 1AA
Ashford and St Peter's Hospitals NHS Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ
Mayday University Hospital NHS Trust
Thornton Heath, Surrey, United Kingdom, CR7 7YE
St George's Hospital NHS Trust
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
The Health Foundation
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00322192    
Other Study ID Numbers: Health Foundation 224/1960
Health Foundation 224/1960
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: May 2006
Keywords provided by St George's, University of London:
Stroke rehabilitation
Physical Therapy
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases