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RECRUITING
NCT06585943
NA

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-09-18

Completion Date

2029-04

Last Updated

2025-10-16

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Forced Rate Exercise + Rehab

The FE+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to \>75 RPM. Target heart rate zone will be set to 60-80% of 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).

BEHAVIORAL

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).

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States