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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322192
• Other study ID #: Health Foundation 224/1960
• Secondary ID: Health Foundatio
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2006
• Last updated: June 8, 2015
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2006
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Conventional UK Physical therapy

• Increased intensity of UK conventional physical therapy

• UK conventional physical therapy plus functional strength training

Locations

Country	Name	City	State
United Kingdom	Epsom and St Helier NHS Trust	Carshalton	Surrey
United Kingdom	Ashford and St Peter's Hospitals NHS Trust	Chertsey	Surrey
United Kingdom	St George's Hospital NHS Trust	London
United Kingdom	Mayday University Hospital NHS Trust	Thornton Heath	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
St George's, University of London	The Health Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum torque around the knee joint
Primary	gait velocity
Secondary	Modified Rivermead Mobility Index
Secondary	Lower limb kinematics during standing up
Secondary	Lower limb kinematics during sitting down
Secondary	Lower limb kinematics during walking
Secondary	timing and pattern of muscle activation during functional activity
Secondary	EuroQuol for health related quality of life
Secondary	Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS