NCT04877444 Exercise Primed Stroke Rehabilitation
| NCT ID | NCT04877444 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | VA Office of Research and Development |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-07-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 persistent physical and mental difficulties such as reduced physical and cognitive function and depression. Developing innovative treatments that address these problems is necessary to improve long-term outcomes for stroke survivors. Aerobic exercise (AEx) can improve physical and cognitive function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to an intervention. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple aspects of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention the investigators aim to advance the rehabilitative care of Veteran stroke survivors.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Ryan E Ross, PhD
PRINCIPAL INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Frequently Asked Questions
Who can join the NCT04877444 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04877444 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04877444 currently recruiting?
Yes, NCT04877444 is actively recruiting participants. Contact the research team at Ryan.Ross2@va.gov for enrollment information.
Where is the NCT04877444 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT04877444 clinical trial?
NCT04877444 is sponsored by VA Office of Research and Development. The principal investigator is Ryan E Ross, PhD at Ralph H. Johnson VA Medical Center, Charleston, SC. The trial plans to enroll 40 participants.
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