Comparative Outcomes of a Pediatric Walking Rehabilitation Robot Combined With Repetitive Transcranial Magnetic Stimulation in Children With Spastic Cerebral Palsy: Protocol for a Prospective Observational Study.

BACKGROUND: Cerebral palsy (CP) is a prevalent neurodevelopmental disorder in children, often leading to long-term motor impairments. Rehabilitation robotics has emerged as a promising approach in pediatric neurorehabilitation, offering precise and repetitive motor training. Repetitive transcranial magnetic stimulation (rTMS), a noninvasive neuromodulation technique, has shown potential in modulating cortical excitability and improving motor function in children with CP. OBJECTIVE: This study aims to evaluate the association between a combined intervention using a pediatric gait rehabilitation robot and rTMS in children with spastic CP. METHODS: This prospective observational study will enroll 108 children with spastic CP who meet the inclusion criteria. Participants will be allocated to either an intervention group (robot-assisted gait training combined with rTMS) or a comparison group (conventional rehabilitation therapy) based on their guardians' preference after standardized information provision. The assignment is nonrandomized and will be documented prospectively. Interventions will be delivered 5 times per week for 8 weeks. Outcomes will be assessed at baseline, week 4, and week 8 using 3D gait analysis, neuromuscular electromyography, the Gross Motor Function Measure-88, and the Modified Ashworth Scale. Comparative analyses will be conducted to evaluate the outcomes of the combined intervention relative to standard rehabilitation. Findings are expected to provide evidence supporting integrated neuromodulation and robotic therapy in pediatric CP rehabilitation. RESULTS: This study was funded in 2024. Study recruitment began in January 2025, and as of June 2026, enrollment is ongoing; exact recruitment numbers are being verified with the research coordinator. This study has been approved by the ethics committee (YJ-2025-020-01) and supported by grants S2024094 and CDS2018Z005. Outcomes will be assessed at baseline, week 4, and week 8 via 3D gait analysis, electromyography, Gross Motor Function Measure-88, Modified Ashworth Scale. Data collection is expected to be complete in December 2027, and the data will be analyzed with SPSS. The results are expected to be published in spring 2028. CONCLUSIONS: This study evaluates the comparative outcomes associated with a pediatric gait rehabilitation robot combined with rTMS for children with spastic CP. Positive findings would suggest a preliminary association between the multimodal protocol and better motor function (including improved gait performance and reduced muscle spasticity), without implying causality. Such results would provide a new evidence-based option for pediatric spastic CP rehabilitation. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2500105823; https://www.chictr.org.cn/showproj.html?proj=274950. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/93798.