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Robotic Exoskeleton Gait Training for Children With Cerebral Palsy
Sponsor: Hunan Normal University
Summary
The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV. The main questions it aims to answer are: Can robotic gait training improve gross motor function and walking ability in children with GMFCS level IV CP? Does robotic training enhance joint range of motion, muscle morphology, and psychological satisfaction in this population? Researchers will compare a robotic gait training group to a usual care group to see if the robotic intervention leads to better physical and psychological outcomes. Participants will: Be randomly assigned to receive either robotic gait training or continue their usual care for 6 months Complete three 45-minute training sessions per week (robotic group only) Undergo physical and psychological assessments at the beginning, midpoint, and end of the study Have their gross motor function, walking ability, joint flexibility, muscle structure, and quality of life measured using validated tools
Official title: Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic Cerebral Palsy
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-10-01
Completion Date
2027-03-01
Last Updated
2025-07-08
Healthy Volunteers
No
Conditions
Interventions
Robotic-assisted gait training
The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. This device integrates real-time motion sensing, adaptive control algorithms, and customizable joint actuation to deliver precise and individualized gait training for children with minimal voluntary motor control. The system allows for the modulation of key gait parameters including joint angles, step length, and walking speed, and incorporates both postural correction and dynamic support harnessing to maintain safety and alignment throughout the session. Robotic sessions will be conducted three times per week over a period of 24 weeks, with each session lasting approximately 45 minutes. All sessions will be conducted at a designat