Robotic Exoskeleton Gait Training for Children With Cerebral Palsy
Megadott ok: The study was terminated due to regulatory conflicts.
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A vizsgálat adatai
- Ki végzi
- Hunan Normal University
- Azonosító
- NCT07049523
- A regiszteradat frissítve
- 2026. június 22.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic Cerebral Palsy
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
Bevonási feltételek: No history of heart disease or family history of heart disease; Children classified as GMFCS level IV; Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living; Medically stable and able to sit upright for at least 30 minutes; Able to understand simple verbal or visual instructions.
Kizáró feltételek: Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment; Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy); Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities; Aged under 6 years or over 12 years.