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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Conventional UK Physical therapy
Increased intensity of UK conventional physical therapy
UK conventional physical therapy plus functional strength training
Sponsored by
St George's, University of London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke rehabilitation, Physical Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Epsom and St Helier NHS Trust
  • Ashford and St Peter's Hospitals NHS Trust
  • Mayday University Hospital NHS Trust
  • St George's Hospital NHS Trust

Outcomes

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

Full Information

First Posted
May 4, 2006
Last Updated
June 8, 2015
Sponsor
St George's, University of London
Collaborators
The Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00322192
Brief Title
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

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St George's, University of London
Collaborators
The Health Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke rehabilitation, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Conventional UK Physical therapy
Intervention Type
Behavioral
Intervention Name(s)
Increased intensity of UK conventional physical therapy
Intervention Type
Behavioral
Intervention Name(s)
UK conventional physical therapy plus functional strength training
Primary Outcome Measure Information:
Title
Maximum torque around the knee joint
Title
gait velocity
Secondary Outcome Measure Information:
Title
Modified Rivermead Mobility Index
Title
Lower limb kinematics during standing up
Title
Lower limb kinematics during sitting down
Title
Lower limb kinematics during walking
Title
timing and pattern of muscle activation during functional activity
Title
EuroQuol for health related quality of life
Title
Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie M Pomeroy, PhD
Organizational Affiliation
St George's University London, UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emma V Cooke, MSc
Organizational Affiliation
St George's University London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond C Tallis, FMedSci
Organizational Affiliation
University of Manchester
Official's Role
Study Director
Facility Information:
Facility Name
Epsom and St Helier NHS Trust
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Ashford and St Peter's Hospitals NHS Trust
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Mayday University Hospital NHS Trust
City
Thornton Heath
State/Province
Surrey
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
St George's Hospital NHS Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27107979
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.
Results Reference
derived

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

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