Protocol for the "stand the future" trial: robotic exoskeleton gait training for non-ambulatory children with spastic
Beier Xia1, Na Mi2, Zhixiang Wen3
1College of Sport Education, Shanghai University of Sport, Shanghai, China.
Insights
This study investigates robotic gait training for children with severe cerebral palsy (CP) (GMFCS level IV). The 6-month trial aims to improve mobility and function in this underserved population.
Area of Science:
- Pediatric Rehabilitation
- Assistive Technology
- Neurology
Background:
- Children with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV experience significant mobility impairments.
- Current rehabilitation programs often exclude these children due to the severity of their condition, highlighting a gap in care.
- Robotic-assisted gait training presents a potential solution for functional improvement in this population, but evidence is limited.
Purpose of the Study:
- To evaluate the effects of a 6-month robotic gait training intervention on children with GMFCS level IV CP.
- To assess improvements in gross motor function, walking capacity, joint range of motion, muscle morphology, and psychological satisfaction.
- To provide empirical evidence for the efficacy of robotic gait training in a severely impaired pediatric population.
Main Methods:
- A two-arm, parallel-group, randomized controlled trial enrolling 36 children (aged 6-12 years) with GMFCS level IV CP.
- Participants were randomized to either robotic gait training (RoboCT system) or usual care.
- Intervention involved 24 weeks of training, 3 times/week for 45 minutes per session. Primary outcomes included the Gross Motor Function Item Set and 1-min walk test.
Main Results:
- Primary outcomes (Gross Motor Function Item Set, 1-min walk test) and secondary outcomes (ankle range of motion, muscle morphology, psychological satisfaction) will be analyzed using linear mixed-effects models.
- Results will be reported in a subsequent publication.
- This trial is one of the first to examine long-term robotic gait training in children with GMFCS level IV CP.
Conclusions:
- Findings may inform evidence-based rehabilitation strategies for children with severe CP.
- This research could improve access to technology-supported interventions for this highly underserved group.
- The study protocol provides a framework for future research in pediatric robotic rehabilitation.
Purpose:
Children with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV face profound mobility limitations and are often excluded from intensive gait rehabilitation programs due to the severity of their impairments. Robotic-assisted gait training offers a promising avenue for functional improvement in this underserved population, yet empirical evidence remains scarce. This protocol describes a trial designed to evaluate the effects of a 6-month robotic gait training intervention on gross motor function, walking capacity, joint range of motion, muscle morphology, and psychological satisfaction in children with GMFCS level IV CP. Results will be reported in a subsequent publication following trial completion.
Methods:
This two-arm, parallel-group, randomized controlled trial will enroll 36 children aged 6-12 years with GMFCS level IV CP. Participants will be randomized 1:1 to either the intervention group (robotic gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot) or the control group (usual care as determined by family preference). The intervention group will receive 45-min sessions, three times per week for 24 weeks. Primary outcomes include Gross Motor Function Item Set and walking capacity (1-min walk test). Secondary outcomes include passive ankle joint range of motion, lower-limb muscle morphology via ultrasound, and psychological satisfaction. Linear mixed-effects models will evaluate group-by-time effects under an intention-to-treat framework.
Discussion:
This will be one of the first trials to explore long-term robotic gait training in children with GMFCS level IV CP. Findings may inform evidence-based rehabilitation approaches and improve access to technology-supported interventions in this highly underserved population.
Clinical Trial Registration:
ClinicalTrials.gov, NCT07049523.
