CUped Exercise Therapy to Improve Lower Limb Movement and Walking After Stroke Using a Robotic Split-Crank Pedaling Device

What this Trial Is About

Researchers are evaluating a novel exercise therapy called CUped to help stroke survivors recover movement in their lower limbs and improve walking ability. Stroke often causes persistent movement problems and few survivors regain independent walking. CUped targets key movement impairments after stroke using a robotic device to encourage use of the affected leg and reduce compensatory movements. This study aims to test CUpeds safety, acceptability, tolerance, and therapeutic effects, providing data to support a future randomized controlled trial. Participants will complete 24 exercise sessions using the CUped device, which involves pedaling with both legs on a split-crank apparatus where motors assist or resist limbs to maintain proper movement timing. Each session includes up to 12 bouts of bilateral uncoupled pedaling, followed by one bout of overground walking training. The exercise is done while sitting to allow high repetition practice and focuses on restoring muscle output, timing, and coordination. Researchers will monitor exercise dose and response throughout the 6-8 week training period. During the study, participants will undergo assessments before, during, and after training to measure paretic limb use and coordination during walking and pedaling. Safety will be tracked through adverse event monitoring and session attendance. Muscle activity and physiological responses such as heart rate and blood pressure will also be measured. The study involves 27 visits including pretest, midtest, posttest, and training sessions, aiming to establish whether CUped is safe, well tolerated, and can elicit therapeutic benefits for stroke survivors.

CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation