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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00037908
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 24, 2002
First Posted Date  ICMJE May 27, 2002
Last Update Posted Date January 21, 2009
Study Start Date  ICMJE October 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis
Official Title  ICMJE Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis
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).

  1. 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.

  2. Standard functional rehabilitation combined with strength training results in greater improvements in motor function than functional rehabilitation alone.
  3. Strength training results in improved control of elbow trajectory tracking movements and shoulder-elbow reaching movements.

Specific Objectives

  1. 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).
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebrovascular Accident
  • Hemiparesis
Intervention  ICMJE Procedure: Strength training
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Post stroke
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037908
Other Study ID Numbers  ICMJE B2405R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: David Wolff, Ph.D. Special Assistant to the Director Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service
Investigator: Danielle M Kerkovitch, Ph.D. Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
PRS Account VA Office of Research and Development
Verification Date May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP