Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 19, 2026
Date Accepted: Jun 16, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparative Efficacy of a Pediatric Walking Rehabilitation Robot Combined With rTMS in the Treatment of Children With Spastic Cerebral Palsy: A Prospective Observational Study Design Protocol
ABSTRACT
Background:
Cerebral palsy (CP) is a prevalent neurodevelopmental disorder in children with special needs, 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 non-invasive neuromodulation technique, has shown potential in modulating cortical excitability and improving motor function in children with CP.
Objective:
This study aims to evaluate the clinical efficacy of a pediatric gait rehabilitation robot combined with rTMS in children with spastic CP.
Methods:
This prospective observational study will enroll 108 children with spastic CP who meet the inclusion criteria. We will equally assign participants to an observation group (robot-assisted gait training combined with rTMS) or a control group (conventional rehabilitation therapy). Interventions will be delivered five times per week for 8 weeks. Outcomes will be assessed at baseline, 4 weeks, and 8 weeks using 3D gait analysis, neuromuscular electromyography, the Gross Motor Function Measure-88 (GMFM-88), and the Modified Ashworth Scale (MAS). Comparative analyses will be conducted to evaluate the effectiveness 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:
Approved by Ethics Committee (YJ-2025-020-01) and supported by S2024094/CDS2018Z005, 108 children with spastic cerebral palsy (CP) will be recruited from Jan. 2025. Outcomes assessed at baseline, Weeks 4 and 8 via 3D gait analysis, electromyography (EMG), GMFM-88, MAS; data collection ends Dec. 2027, analyzed with SPSS v26.0.
Conclusions:
This study evaluates the efficacy of a pediatric gait rehabilitation robot combined with rTMS for children with spastic CP. Positive findings could establish a safe, non-invasive multimodal protocol to improve motor function and gait performance, reduce muscle spasticity, and provide a new evidence-based option for pediatric spastic CP rehabilitation. Clinical Trial: Chinese Clinical Trial Registry: ChiCTR2500105823.
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