STUDY PROTOCOL article
Front. Neurol.
Sec. Neurorehabilitation
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1651913
This article is part of the Research TopicNew methods in neurorehabilitationView all 19 articles
Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children with Spastic Cerebral Palsy
Provisionally accepted- 1College of Sport Education, Shanghai University of Sport, Shanghai, China
- 2College of Physical Education, Hunan Normal University, Changsha, China
- 3College of Arts and Science, Hubei Normal University, Huangshi, China
- 4Independent person, Windermere, FL, United States
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
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-minute sessions, three times per week for 24 weeks. Primary outcomes include Gross Motor Function Item Set and walking capacity (1-minute 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. Trial Registration: ClinicalTrials.gov (NCT07049523), registered on July 2, 2025.
Keywords: Fascicle length, Muscle Volume, Motor development, Gait, Rehabilitation
Received: 22 Jun 2025; Accepted: 03 Oct 2025.
Copyright: © 2025 Xia, Wen, Mi and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Zhixiang Wen, 457254754@qq.com
Na Mi, 302990032@qq.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.