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I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT06585943

Registry updated: 2026-09-16

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Description

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.

Interventions

Forced Rate Exercise + Rehab (Behavioral)
The FE+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to \>75 RPM. Target heart rate zone will be set to 60-80% of HR reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).
Rehabilitation (Behavioral)
The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).

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 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

Conditions

Stroke

Locations

Cleveland Clinic — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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