A Phase I/II Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton to Improve Gait in Children With Movement Disorders

What this Trial Is About

Researchers are investigating whether a robotic device worn on the legs can improve walking ability in children aged 3 to 17 years who have gait disorders involving the knee joint due to cerebral palsy, spina bifida, muscular dystrophy, or incomplete spinal cord injury. The study aims to assess the effectiveness of this wearable robot in improving knee extension and overall gait function compared to standard therapy. This trial is a randomized crossover design conducted by the National Institutes of Health Clinical Center. Participants will undergo three 12-week phases. One phase involves continuing their usual therapy, another phase includes using a customized robotic exoskeleton in a lab setting with different modes to assist or challenge walking, and the third phase allows participants to take the exoskeleton home for daily use — walking at least one hour per day, five days per week. The exoskeleton is tailored to each child through leg scanning, and its use will be monitored for safety and compliance. Throughout the study, participants will have their walking ability assessed using physical exams, movement recordings with body markers, and tests of muscle strength and motor function before and after each phase. Researchers will measure knee joint angle during walking as the primary outcome, along with changes in muscle activity, gait speed, and gross motor function. Follow-up assessments will continue six weeks post-intervention to observe lasting effects. The total study participation spans 36 weeks.

Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders