IRB Study Number 23-1262
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Neurological Institute
Description
Traditional rehabilitation approaches are time and personnel intensive and costly, and leave ~75% of stroke survivors with residual disability. This is a prospective, single-center, parallel group, rater-blind, pragmatic randomized 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 determine 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.
Inclusion Criteria
- 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
- Fugl-Meyer motor score 19-55 in the involved UE
- Fugl-Meyer score <34 in the involved LE demonstrating residual hemiparesis
- Ambulatory ≥ 20 meters with no more than contact guard assistance
- 18-85 years of age
Exclusion Criteria
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
- cardiac arrhythmia
- hypertrophic cardiomyopathy
- history of multiple strokes
- actively undergoing physical or occupational therapy or enrolled in another interventional study
- severe aortic stenosis
- untreated deep vein thrombosis or pulmonary embolus
- unstable angina
- uncontrolled hypertension
- implanted pacemaker or defibrillator
- dyspnea at rest
- clinically significant neurologic condition/diagnosis other than stroke
- recent history of elicit drug or alcohol misuse or significant mental health illness
- significant contractures
- anti-spasticity injection within 3 months of enrollment
- skull hardware (e.g. screws/plates) or prior craniotomies that could shunt current flow altering EEG measures
- other contraindication to exercise or EEGs
