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Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis

Primary Purpose

Cerebrovascular Accident, Hemiparesis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Strength training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Stroke, Hemiparesis, Upper limb function, Strength training

Eligibility Criteria

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

Post stroke

Sites / Locations

  • VAMC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00037908
Brief Title
Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis
Official Title
Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
Our overall goal is to develop therapeutic interventions to improve upper-limb motor function in hemiparetic persons based on an improved understanding of the mechanisms responsible for its loss and recovery. We intend to rigorously evaluate the efficacy of these interventions with clinical trials, and to study the mechanisms by which these interventions affect motor recovery. In this proposal, we will use a controlled, randomized, double blind clinical trial to study the effects of shoulder and elbow strength training in subjects in the subacute phase of recovery following stroke.
Detailed Description
Hypotheses: The specific hypotheses that we will test in this proposal all refer to persons with post-stroke hemiparesis in the subacute phase of recovery (completed all out-patient therapy programs, but still less than 6 months post-CVA). a) Standard functional rehabilitation combined with strength training in the form of high-intensity resistance exercise results in greater gains in elbow and shoulder strength than standard functional rehabilitation alone. b) This increased strength is not accompanied by increased hypertonia. c) This increased strength is not accompanied by significant muscular hypertrophy. Standard functional rehabilitation combined with strength training results in greater improvements in motor function than functional rehabilitation alone. Strength training results in improved control of elbow trajectory tracking movements and shoulder-elbow reaching movements. Specific Objectives To perform a controlled, randomized, double-blind clinical trial to test the effects of high-intensity resistance exercise at the shoulder and elbow. Two interventions will be compared: standard functional rehabilitation (SFR), and standard functional rehabilitation combined with high-intensity resistance exercise (strength training) (SFR+STR). We will study persons with post-stroke hemiparesis in the subacute phase of recovery, i.e. having completed all outpatient therapy programs, but still less than 6 months post-CVA. Outcome measures will include strength (maximal voluntary isovelocity joint torque), hypertonia (onset threshold of the stretch reflex, Modified Ashworth Scale), standard clinical assessment of activities of daily living (Barthel Index, Functional Independence Measure), and upper extremity motor function (Fugl-Meyer exam, Functional Test of the Hemiparetic Upper Extremity). To study the neuromuscular mechanisms associated with improvements in strength and motor control that result from these interventions. Strength changes will be investigated by measuring muscle hypertrophy, hyperreflexia, and passive stiffness. Changes in control of upper extremity movements will be investigated by measuring motor performance and muscle activation patterns in trajectory tracking and reaching tasks. Our long term goal is to develop therapeutic interventions to improve upper-limb motor function in persons with post-stroke hemiparesis. Improved motor function involves not only increased strength at the shoulder and elbow, but also increased strength and dexterity at the wrist and hand. The proposed study will establish a foundation by demonstrating the positive effects of strength training in persons with hemiparesis. Then, in future studies, we can investigate the effects of specific interventions at the hand and wrist and investigate physiologic mechanisms subserving change in neuromuscular function following strength training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Hemiparesis
Keywords
Stroke, Hemiparesis, Upper limb function, Strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Strength training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Post stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wolff, Ph.D. Special Assistant to the Director
Organizational Affiliation
Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Danielle M Kerkovitch, Ph.D.
Organizational Affiliation
Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
Facility Information:
Facility Name
VAMC
City
Palo Alto
State/Province
California
Country
United States

12. IPD Sharing Statement

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Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis

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