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

June 8, 2015 updated by: St George's, University of London

The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • St George's Hospital NHS Trust
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • Epsom and St Helier NHS Trust
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Ashford and St Peter's Hospitals NHS Trust
      • Thornton Heath, Surrey, United Kingdom, CR7 7YE
        • Mayday University Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Maximum torque around the knee joint
gait velocity

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 5, 2006

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Health Foundation 224/1960

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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