Evaluating a New Robot-Assisted Gait Training Device for Adults With Chronic Stroke Between 6 Months and 3 Years After Onset

What this Trial Is About

Walking rehabilitation after a stroke is most effective within the first three months, but many patients beyond six months can still improve their walking ability. Researchers are studying a new end-effector exoskeleton robot system called HIWIN MRG-P110 to see how usable and effective it is for gait training in patients who are 6 months to 3 years post-stroke. This randomized, single-blind study will enroll 60 stroke survivors with limited walking ability to test this new device. Participants will be randomly assigned to one of two groups an active-assistive mode group, where the robot helps but encourages voluntary movement, or a fully passive mode group, where the robot moves the legs without active assistance. Both groups will receive 15 treatment sessions over 5 weeks using the HIWIN MRG-P110 device. The study will compare improvements in walking and balance as well as brain activity changes measured by functional near-infrared spectroscopy. During the study, participants will complete walking tests before treatment, immediately after the last session, and again 3 months later. Researchers will assess gait, balance, and brain function to evaluate the robots effects. Participants must attend all treatment sessions and follow-up assessments. The study lasts about 3 months, including treatment and follow-up, with careful monitoring of safety and progress throughout.

The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors