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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by St George's, University of London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Health Foundation
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00322192
First received: May 4, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Maximum torque around the knee joint
  • gait velocity

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: January 2004
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322192

Contacts
Contact: Valerie M Pomeroy, PhD +44(0)20 8725 5327 v.pomeroy@sgul.ac.uk

Locations
United Kingdom
Epsom and St Helier NHS Trust Recruiting
Carshalton, Surrey, United Kingdom, SM5 1AA
Principal Investigator: Valerie M Pomeroy, PhD         
Sub-Investigator: Emma V Cooke, MSc         
Ashford and St Peter's Hospitals NHS Trust Recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Principal Investigator: Valerie M Pomeroy, PhD         
Sub-Investigator: Emma V Cooke, MSc         
Mayday University Hospital NHS Trust Active, not recruiting
Thornton Heath, Surrey, United Kingdom, CR7 7YE
St George's Hospital NHS Trust Recruiting
London, United Kingdom, SW17 0RE
Principal Investigator: Valerie M Pomeroy, PhD         
Sub-Investigator: Emma V Cooke, MSc         
Sponsors and Collaborators
St George's, University of London
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00322192     History of Changes
Other Study ID Numbers: Health Foundation 224/1960, Health Foundation 224/1960
Study First Received: May 4, 2006
Last Updated: May 4, 2006
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:
Stroke rehabilitation
Physical Therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 01, 2014