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

NCT ID: NCT00322192

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2006-12-31

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

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Conventional UK Physical therapy

Intervention Type: BEHAVIORAL

Increased intensity of UK conventional physical therapy

Intervention Type: BEHAVIORAL

UK conventional physical therapy plus functional strength training

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Health Foundation

OTHER

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Principal Investigators

Valerie M Pomeroy, PhD

Role: STUDY_CHAIR

St George's University London, UK

Emma V Cooke, MSc

Role: PRINCIPAL_INVESTIGATOR

St George's University London, UK

Raymond C Tallis, FMedSci

Role: STUDY_DIRECTOR

University of Manchester

Locations

St George's Hospital NHS Trust

London, London, United Kingdom

Epsom and St Helier NHS Trust

Carshalton, Surrey, United Kingdom

Ashford and St Peter's Hospitals NHS Trust

Chertsey, Surrey, United Kingdom

Mayday University Hospital NHS Trust

Thornton Heath, Surrey, United Kingdom

Countries

United Kingdom

References

Kerr A, Clark A, Cooke EV, Rowe P, Pomeroy VM. Functional strength training and movement performance therapy produce analogous improvement in sit-to-stand early after stroke: early-phase randomised controlled trial. Physiotherapy. 2017 Sep;103(3):259-265. doi: 10.1016/j.physio.2015.12.006. Epub 2016 Feb 11.

Reference Type: DERIVED

PMID: 27107979 (View on PubMed)

Other Identifiers

Health Foundation 224/1960

Identifier Type: -

Identifier Source: secondary_id

Health Foundation 224/1960

Identifier Type: -

Identifier Source: org_study_id