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

Launched by THE CLEVELAND CLINIC · Sep 3, 2024

Keywords

ClinConnect Summary

The I-Score clinical trial is studying a new way to help people recover from strokes using forced aerobic exercise, which means using a machine to assist with exercise to improve movement in arms and legs. Traditional rehab methods can be time-consuming and expensive, and many stroke survivors still struggle with disabilities afterward. This trial aims to see if this new approach can help improve recovery more effectively and at a lower cost than standard rehabilitation.

To participate in the trial, individuals must be between 18 and 85 years old, have had a stroke 3 to 9 months ago, and have some movement ability with their arms and legs. Participants should be able to walk at least 20 meters with minimal help. The trial is currently recruiting participants, and those who join can expect to engage in specially designed exercise sessions while researchers monitor their progress. It's a chance to contribute to stroke recovery research that could benefit many people in the future.

Gender

ALL

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