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Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Conventional UK physical therapy
Increased intensity of UK conventional physical therapy (PT)
UK conventional PT 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: Be between one week and three months after stroke when recruited to the study Have some voluntary muscle activity in the paretic upper limb Exclusion Criteria: Obvious unilateral visuospatial neglect Upper limb movement deficits attributable to non-stroke pathology

Sites / Locations

  • St George's Hospital NHS Trust

Outcomes

Primary Outcome Measures

Action Research Arm Test (ARAT)
Nine Hole Peg Test (9HPT)

Secondary Outcome Measures

peak torque around the elbow joint in elbow flexion and extension
grip force
pinch force
smoothness of movement during turning a cranked wheel
reciprocal inneveration of biceps and triceps during turning of a cranked wheel.

Full Information

First Posted
August 3, 2006
Last Updated
June 5, 2015
Sponsor
St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00360789
Brief Title
Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke
Official Title
The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (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

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 pilot clinical trial (Phase II). Subjects will be within 3 months of first stroke with some voluntary movement in the paretic upper limb. A Research Physiotherapist, blinded to measurement, will recruit subjects, allocate subjects to one of three intervention groups using sequentially numbered sealed envelopes containing previously allocated intervention cards and provide interventions. Ten participants will be recruited to each group therefore the trial will recuit 30 participants. The Research Assessor, 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, five 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 the Action Research Arm Test (ARAT)and the Nine Hole Peg Test (9HPT). The secondary outcomes are peak torque around the elbow joint in elbow flexion and extension, grip force, pinch force, smoothness of movement during turning a cranked wheel and reciprocal inniveration of biceps and triceps during turning of a cranked wheel. Data will be analysed using descriptive statistics and the estimation of standard deviations will be used to inform a power calculation to estimate sample size for a Phase II randomised controlled trial.

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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (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 (PT)
Intervention Type
Behavioral
Intervention Name(s)
UK conventional PT plus functional strength training
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Title
Nine Hole Peg Test (9HPT)
Secondary Outcome Measure Information:
Title
peak torque around the elbow joint in elbow flexion and extension
Title
grip force
Title
pinch force
Title
smoothness of movement during turning a cranked wheel
Title
reciprocal inneveration of biceps and triceps during turning of a cranked wheel.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be between one week and three months after stroke when recruited to the study Have some voluntary muscle activity in the paretic upper limb Exclusion Criteria: Obvious unilateral visuospatial neglect Upper limb movement deficits attributable to non-stroke pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie M Pomeroy, PhD
Organizational Affiliation
St George's, University of London
Official's Role
Study Chair
Facility Information:
Facility Name
St George's Hospital NHS Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

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Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke

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