Clinical trial NCT00322192: Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke
Official title: The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke rehabilitation
Physical Therapy
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: The Health Foundation
First posted: 2006-05-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum torque around the knee joint
measure: gait velocity
Secondary outcomes:
measure: Modified Rivermead Mobility Index
measure: Lower limb kinematics during standing up
measure: Lower limb kinematics during sitting down
measure: Lower limb kinematics during walking
measure: timing and pattern of muscle activation during functional activity
measure: EuroQuol for health related quality of life
measure: Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS
Other outcomes:
Locations:
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier NHS Trust
state: Surrey
city: Chertsey
country: United Kingdom
facility: Ashford and St Peter's Hospitals NHS Trust
state: Surrey
city: Thornton Heath
country: United Kingdom
facility: Mayday University Hospital NHS Trust
state: Surrey
city: London
country: United Kingdom
facility: St George's Hospital NHS Trust
Study officials:
affiliation: St George's University London, UK
name: Valerie M Pomeroy, PhD
role: STUDY_CHAIR
affiliation: St George's University London, UK
name: Emma V Cooke, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Raymond C Tallis, FMedSci
role: STUDY_DIRECTOR
References:
citation: 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.