Clinical study on the safety and feasibility of AiWalker-K for lower limbs exercise rehabilitation in children with cerebral palsy

Background Robotic-assisted gait training (RAGT) devices are effective for children with cerebral palsy (CP). Many RAGT devices have been created and put into clinical rehabilitation treatment. Therefore, we aimed to investigate the safety and feasibility of a new RAGT for children with CP. Methods This study is a cross-over design with 23 subjects randomly divided into two groups. The occurrence of adverse events and changes in heart rate and blood pressure were recorded during each AiWalker-K training. Additionally, Gross Motor Function Measure-88 (GMFM-88), Pediatric Balance Scale (PBS), 6 Minutes Walking Test (6MWT), Physiological Cost Index, and Edinburgh Visual Gait Score (EVGS) were used to assess treatment, period, carry-over, and follow-up effects in this study. Results Adverse events included joint pain, skin pain, and injury. Heart rate and blood pressure were higher with the AiWalker-K compared to the rest (P Conclusions Under the guidance of experienced medical personnel, AiWalker-K can be used for rehabilitation in children with CP.