Status:
RECRUITING
Exercise Primed Stroke Rehabilitation
Lead Sponsor:
VA Office of Research and Development
Conditions:
Stroke
Eligibility:
All Genders
50-90 years
Phase:
EARLY_PHASE1
Brief Summary
Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persi...
Detailed Description
The purpose of this project is to examine the 'priming' effect of aerobic exercise (AEx) on a motor rehabilitation intervention for chronic stroke survivors. Aerobic exercise (AEx) promotes numerous f...
Eligibility Criteria
Inclusion
- experienced unilateral stroke at least 6 months prior;
- voluntarily shoulder flexion of the affected arm 20 degrees with simultaneous elbow extension 10 degrees;
- moderate arm movement impairment (UE Fugl-Meyer Assessment \> 21 but \< 52 points;
- passive range of motion in paretic shoulder, elbow, wrist, thumb and fingers within 20 degrees of normal;
- 50-90 years of age;
- ability to communicate as per the therapists' judgement at baseline testing;
- ability to complete and pass an exercise tolerance test; 8) Box \& Block test score of at least 3 blocks in 60 seconds with the affected arm.
Exclusion
- lesion in brainstem/cerebellum as these may interfere with visual-perceptual/cognitive skills needed for motor re-learning;
- presence of other neurological disease that may impair motor learning skills;
- orthopedic condition or impaired corrected vision that alters reaching ability (e.g., prior rotator cuff tear without full recovery);
- paretic arm pain that interferes with reaching;
- unable to understand or follow 3-step directions;
- severe cognitive impairment (MoCA score 17);
- severe aphasia;
- inability to read English,
- history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
- Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest;
- History of COPD or oxygen dependence;
- History of DVT or pulmonary embolism within 6 months;
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
- UBACC score \< 15; and for brain stimulation procedures only:
- electronic or metallic implants;
- history of seizures;
- women of child bearing potential.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04877444
Start Date
July 1 2021
End Date
January 31 2027
Last Update
January 9 2026
Active Locations (1)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703