- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037908
Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States
- VAMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- David Wolff, Ph.D. Special Assistant to the Director, Program Analysis and Review Section (PARS) VA Rehabilitation Research & Development Service
- Danielle M Kerkovitch, Ph.D., Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2405R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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