I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
This study is looking at whether a special type of exercise called Forced Rate Exercise (FE) combined with rehabilitation can help people recover better after a stroke. FE involves cycling where the machine helps you pedal faster than you might on your own. Researchers want to see if this approach improves movement in your arms and legs more than traditional rehabilitation alone. They also want to understand how FE works in the body and if it's a cost-effective treatment. You may be able to join if you are 18 to 85 years old, had a stroke 3-9 months ago, and meet certain criteria for arm movement. The study plans to enroll 66 people.
- Study design
- This interventional study plans to enroll 66 participants, comparing two groups: one receiving Forced Rate Exercise plus rehabilitation, and another receiving rehabilitation alone.
- What's involved
- If you join, you would participate in either Forced Rate Exercise sessions with rehabilitation or rehabilitation sessions. Your arm movement, walking speed, and blood samples will be measured at the start, after 12 weeks of treatment, and 6 months later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the end of treatment to assess arm movement and walking speed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
At a glance
Conditions
NCT06585943
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Susan Linder, PT, DPT, PhD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Upper Extremity Fugl-Meyer Motor AssessmentBaseline to end of treatment at 12 weeks and end of treatment + 6 months
Impairment-based measure of the upper extremity post-stroke.
- Gait VelocityBaseline to end of treatment at 12 weeks and end of treatment + 6 months
Gait velocity obtained using motion capture.
- Plasma IGF-1Before and after first and 24th treatment session
Blood biomarker for neuroplasticity
- Serum BDNFBefore and after first and 24th treatment session
Blood biomarker for neuroplasticity
- electroencephalogramsBaseline and end of treatment at 12 weeks
Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas during active/passive UE and LE movements
- electroencephalogramsBaseline and end of treatment at 12 weeks
Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas under each cycling condition
- electroencephalogramsBaseline and end of treatment at 12 weeks
Electroencephalograms will be obtained to quantify inter-area communication and direction of information flow.
- Incremental cost-effectiveness ratiobaseline to end of treatment at 12 weeks and baseline to end of treatment + 6 months
Incremental cost-effectiveness ratio (ICER) expressed as cost per quality of life years (QALY) will be computed using a healthcare perspective.
- Stroke Impact ScaleBaseline to end of treatment at 12 weeks and end of treatment + 6 months
Self-reported quality of life measure, normalized to a score from 0-100 with higher scores indicative of better self-reported quality of life