MedTrace Logo

Robotic Exoskeleton Gait Training for Children With Cerebral Palsy

NCT07049523 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-08

No results posted yet for this study

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

Conditions

  • Cerebral Palsy

Interventions

DEVICE

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

Sponsors & Collaborators

  • Hunan Normal University

    lead OTHER

Principal Investigators

  • Bo Zhou, PhD · Hunan Normal University, College of Physical Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-03-01
Completion
2027-03-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049523 on ClinicalTrials.gov