Intensive cycling exercise for stroke recovery
Official title: The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
Run by The Cleveland Clinic · NCT06585943 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | September 18, 2024 |
| Main results expected | October 2028 |
| Study ends | April 2029 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT06585943 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 18-85 who are 3-9 months post-stroke with specific motor function scores indicating residual hemiparesis.
✕Probably not a fit
Patients with recent cardiac issues, multiple strokes, or those currently undergoing other therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with forced aerobic exercise in animal models, but this approach is relatively novel in human stroke rehabilitation.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
-
Dual-task balance training plus computer-based cognitive training after stroke
In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.