Intensive cycling exercise for stroke recovery
The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
This study is testing whether using a special cycling machine can help stroke survivors recover better during their outpatient rehab compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06585943 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of forced aerobic exercise (FE) on motor recovery in stroke survivors during outpatient rehabilitation. It aims to compare the effectiveness and cost-effectiveness of FE, which involves mechanically assisted cycling, against traditional rehabilitation methods. The study will assess both the neural and biochemical mechanisms behind the recovery facilitated by FE, as well as its potential to improve outcomes for a significant portion of stroke survivors who currently experience residual disabilities. By rigorously testing this approach, the trial seeks to advance clinical practices in stroke rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-85 who are 3-9 months post-stroke with specific motor function scores indicating residual hemiparesis.
Not a fit: Patients with recent cardiac issues, multiple strokes, or those currently undergoing other therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance motor recovery for stroke survivors while reducing rehabilitation costs.
How similar studies have performed: Previous studies have shown promising results with forced aerobic exercise in animal models, but this approach is relatively novel in human stroke rehabilitation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Susan Linder, PT, DPT, PhD — The Cleveland Clinic
- Study coordinator: Courtney Miller, PT, DPT
- Email: millerc5@ccf.org
- Phone: 216 509-7012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.