NCT06585943Recruiting
I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 18 Sept 2024
- Primary completion date
- Oct 2028
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Stroke
- NCT number
- NCT06585943
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 18 Sept 2024 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- actively undergoing physical or occupational therapy or enrolled in another interventional study
- skull hardware (e.g. screws/plates) or prior craniotomies that could shunt current flow altering EEG measures
Other illness
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
- cardiac arrhythmia
- history of multiple strokes
- untreated deep vein thrombosis or pulmonary embolus
- unstable angina
- uncontrolled hypertension
- clinically significant neurologic condition/diagnosis other than stroke
- recent history of elicit drug or alcohol misuse or significant mental health illness
Other
- hypertrophic cardiomyopathy
- severe aortic stenosis
- implanted pacemaker or defibrillator
- dyspnea at rest
- significant contractures
- anti-spasticity injection within 3 months of enrollment
- other contraindication to exercise or EEGs
Criteria the registry did not label
- 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:
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.