Actively Recruiting
I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
Led by The Cleveland Clinic · Updated on 2025-10-16
66
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- 3 to 9 months after a first ischemic or hemorrhagic stroke confirmed by imaging
- Fugl-Meyer motor score between 19 and 55 in the affected upper extremity
- Fugl-Meyer motor score less than 34 in the affected lower extremity showing residual weakness
- Able to walk at least 20 meters with no more than contact guard assistance
You will not qualify if you...
- Hospitalization for myocardial infarction, heart failure, or heart surgery within the past 3 months
- Cardiac arrhythmia or hypertrophic cardiomyopathy
- History of multiple strokes
- Currently undergoing physical or occupational therapy or enrolled in another interventional study
- Severe aortic stenosis
- Untreated deep vein thrombosis or pulmonary embolism
- Unstable angina or uncontrolled hypertension
- Implanted pacemaker or defibrillator
- Shortness of breath at rest
- Neurologic conditions other than stroke
- Recent illicit drug or alcohol misuse or significant mental health illness
- Significant contractures
- Anti-spasticity injections within 3 months before enrollment
- Skull hardware or prior brain surgery affecting EEG measures
- Other contraindications to exercise or EEGs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
C
Courtney Miller, PT, DPT
CONTACT
D
Donayja Harris, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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