No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for people who have had a stroke 3 to 9 months ago and want to improve their movement. Participants will engage in a special exercise program to help recovery in their arms and legs.
Are You a Good Fit for This Trial?
Rules you outHeart failureSevere aortic stenosis
You may be able to join if
I have had a stroke within the last 3 to 9 months.
I can move my affected arm but need help.
I can walk at least 20 meters with some assistance.
I am between 18 and 85 years old.
You may not be able to join if
I have had a heart attack or heart surgery in the past 3 months.
I have serious heart problems like arrhythmia.
I have had multiple strokes.
I am currently in physical or occupational therapy.
I have untreated deep vein thrombosis or a pulmonary embolism.
I have unstable angina or uncontrolled high blood pressure.
I have a significant mental health issue or substance misuse.
I have significant physical limitations like contractures.
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.
Traditional rehabilitation approaches are time and personnel intensive and costly, and leave \~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochem…
Traditional rehabilitation approaches are time and personnel intensive and costly, and leave \~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance.
Trial Locations
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Eligibility Criteria
Sixty-six individuals with chronic stroke able to provide informed consent who meet the following criteria for inclusion will be recruited from the Cleveland Clinic:
1. 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
2. Fugl-Meyer motor…
Sixty-six individuals with chronic stroke able to provide informed consent who meet the following criteria for inclusion will be recruited from the Cleveland Clinic:
1. 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
2. Fugl-Meyer motor score 19-55 in the involved UE
3. Fugl-Meyer score \<34 in the involved LE demonstrating residual hemiparesis
4. Ambulatory ≥ 20 meters with no more than contact guard assistance
5. 18-85 years of age
Exclusion criteria include:
1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
2. cardiac arrhythmia
3. hypertrophic cardiomyopathy
4. history of multiple strokes
5. actively undergoing physical or occupational therapy or enrolled in another interventional study
6. severe aortic stenosis
7. untreated deep vein thrombosis or pulmonary embolus
8. unstable angina
9. uncontrolled hypertension
10. implanted pacemaker or defibrillator
11. dyspnea at rest
12. clinically significant neurologic condition/diagnosis other than stroke
13. recent history of elicit drug or alcohol misuse or significant mental health illness
14. significant contractures
15. anti-spasticity injection within 3 months of enrollment
16. skull hardware (e.g. screws/plates) or prior craniotomies that could shunt current flow altering EEG measures
17. other contraindication to exercise or EEGs
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