Robotic Exoskeleton Gait Training for Children With Cerebral Palsy

NCT ID: NCT07049523

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-03-01

Brief 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

Detailed Description

Cerebral palsy (CP) remains the most common motor disability in childhood, affecting approximately 17 million people worldwide, with an estimated 2-3 per 1,000 live births. In China alone, the number of children with CP is estimated to exceed 6 million, with approximately 40,000 new cases occurring each year. Notably, a substantial proportion of these children are classified as Gross Motor Function Classification System (GMFCS) levels IV or V, indicating they are either non-ambulatory or severely limited in voluntary movement (Li et al., 2018). Children with GMFCS levels IV and V often exhibit pronounced spasticity, limited voluntary muscle control, and severe deficits in selective motor control. Muscle fibers in these children show altered histological features including reduced cross-sectional area, increased collagen deposition, and impaired oxidative capacity. These pathological characteristics further exacerbate limitations in force generation and movement efficiency. These children experience profound impairments in mobility, postural control, and independence, presenting critical challenges for their physical and psychological development.

As the investigators recently reported in a systematic review, current physical rehabilitation strategies for children with CP are derived from studies involving ambulatory children (GMFCS I-III), while the severely affected population (GMFCS IV-V) remains underrepresented in the literature. The absence of walking ability in these children precludes participation in many conventional physiotherapeutic or strength-based programs, resulting in stagnated motor development and a cascade of secondary complications including muscle atrophy, contractures, and social exclusion. In addition to clinical burdens, non-ambulatory children with CP present significant lifelong economic challenges for families and healthcare systems. Estimates suggest that the lifetime cost of care for a single individual with CP can exceed $1.6 million USD in high-income countries, with costs related to direct medical care, assistive equipment, caregiving, and loss of productivity. In China, the economic burden is compounded by disparities in access to rehabilitation services and limited insurance coverage for long-term care.

Recent advancements in robotics and wearable technologies have opened new avenues for restoring movement in neurologically impaired individuals. Robotic exoskeletons and powered orthoses offer the potential to provide task-specific, repetitive, and intensive gait training while minimizing therapist workload. Such devices have shown promise in adult populations with spinal cord injury and stroke, and early-stage trials have extended these technologies to pediatric neuromuscular disorders, including CP. However, empirical data on the feasibility, safety, and efficacy of prolonged robotic gait training in children with GMFCS IV and V classifications are virtually nonexistent.

This protocol outlines a prospective 6-month intervention trial aimed at evaluating the effectiveness of robotic exoskeleton gait training on motor and psychological outcomes in children with severe CP. Through this study, the investigators aim to establish initial empirical evidence for the feasibility and potential benefits of exoskeleton-assisted rehabilitation in children who are traditionally excluded from active gait training. The investigators hypothesize that children with GMFCS level IV CP will demonstrate measurable improvements in motor function, mobility, and subjective well-being. This trial addresses a major gap in pediatric neurorehabilitation and may provide a critical foundation for scaling up robotic interventions in underserved clinical populations.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regular rehabilitation

Participants assigned to the regular rehabilitation (control) group will continue receiving their usual care as determined by their caregivers. Usual care may include activities such as home-based stretching, passive range-of-motion exercises, school-based physiotherapy, or outpatient therapy. There will be no restrictions on care choices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Robotic-assisted gait training

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Aged under 6 years or over 12 years;
• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Normal University

OTHER

Sponsor Role: lead

Responsible Party

Yang Zhang

Principle scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Zhou, PhD

Role: STUDY_DIRECTOR

Hunan Normal University, College of Physical Education

Central Contacts

Yang Zhang, PhD

Role: CONTACT

yzhang68@crimson.ua.edu

727-252-9687

Dinghua Liu, MS

Role: CONTACT

8618807486231

Other Identifiers

2025-506

Identifier Type: -

Identifier Source: org_study_id