Evaluating SHAJA-R Exoskeleton Training for Improving Walking After Stroke Compared to Conventional Therapy

What this Trial Is About

Researchers are investigating the safety, reliability, and short-term effects of gait training using the SHAJA unilateral hip exoskeleton in adults who have had a stroke. This clinical trial aims to determine if SHAJA-based training improves walking speed and endurance better than conventional gait training. The study also evaluates the devices safety and reliability during rehabilitation. Participants will be randomly assigned to two groups. One group will first complete six sessions of SHAJA-assisted gait training followed by six sessions of conventional gait training, while the other group will do the opposite sequence. Each gait training session involves overground walking for 30 to 40 minutes, either with the SHAJA exoskeleton or without it. The trial includes two treatment periods and multiple assessment visits. During the study, participants will have five evaluation sessions to measure walking speed, endurance, gait characteristics, balance, and muscle strength. Assessments include the 10 Metre Walk Test, Walk Test, Timed-Up-and-Go test, and various clinical scales. Researchers will monitor for device-related issues and adverse events from before training until about three months afterward. The total follow-up lasts approximately 14 weeks after the initial evaluation.

Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton