NCT06585943 I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
| NCT ID | NCT06585943 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2024-09-18 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Susan Linder, PT, DPT, PhD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06585943 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585943 currently recruiting?
Yes, NCT06585943 is actively recruiting participants. Contact the research team at millerc5@ccf.org for enrollment information.
Where is the NCT06585943 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06585943 clinical trial?
NCT06585943 is sponsored by The Cleveland Clinic. The principal investigator is Susan Linder, PT, DPT, PhD at The Cleveland Clinic. The trial plans to enroll 66 participants.
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