The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Courtney Miller, PT, DPT
millerc5@ccf.org
216 509-7012
Backup
Donayja Harris, BS
harrisD47@ccf.org
216 445-2007
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2029-04
Participants
Target number of participants: 66
Treatments
Active_comparator: Forced Rate Exercise + Rehabilitation
The forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to \>75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).
Active_comparator: Rehabilitation
The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov