No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 – 90
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for stroke survivors who want to improve their physical and mental function. Participants will combine aerobic exercise with physical rehabilitation to see how it helps their recovery.
Are You a Good Fit for This Trial?
Rules you outCongestive heart failureCOPDDVTSeizures
You may be able to join if
I had a stroke at least 6 months ago.
I can lift my affected arm at least 20 degrees.
I have some arm movement but still need help.
I am between 50 and 90 years old.
I can communicate with the therapists.
I can complete an exercise test.
I scored at least 3 blocks on the Box & Block test.
You may not be able to join if
I have a brainstem or cerebellum lesion.
I have another neurological disease affecting my movement.
I have an orthopedic condition that affects my reaching ability.
I have pain in my affected arm that interferes with reaching.
I cannot understand or follow 3-step directions.
I have severe cognitive impairment.
I cannot read English.
I have severe hypertension.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ou…
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.
Trial Locations
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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 …
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.
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