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Robotic Exoskeleton Gait Training for Children With Cerebral Palsy 36
Clinical Trial NCT07049523 is an interventional study for Cerebral Palsy and is currently not yet recruiting. Enrollment is planned to begin on 1 October 2025 and continue until the study accrues 36 participants. Led by Hunan Normal University, this study is expected to complete by 1 March 2027. The latest data from ClinicalTrials.gov was last updated on 8 July 2025.
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...
Show MoreDetailed 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 Sys...Show More
Official Title
Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic Cerebral Palsy
Conditions
Cerebral PalsyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2025-506
NCT ID Number
Start Date (Actual)
2025-10-01
Last Update Posted
2025-07-08
Completion Date (Estimated)
2027-03-01
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
fascicle length
muscle volume
motor development
gait
rehabilitation
muscle volume
motor development
gait
rehabilitation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionRegular 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. | N/A |
ExperimentalRobotic-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. | 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...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Gross Motor Function Measure - Item Set (GMFM-IS) | Gross motor function will be evaluated using the Gross Motor Function Measure - Item Set (GMFM-IS), a validated short-form tool derived from the full GMFM-66, appropriate for assessing changes in children with CP (Russell et al., 2010). It focuses on key motor tasks across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. In this study, trained evaluators will observe children as they perform selected motor tasks from the GMFM-IS. Each task will be scored on a 4-point ordinal scale: 0 = does not initiate; 1 = initiates (\<10% of the task); 2 = partially completes (10-99%); 3 = completes the task independently. The assessment will take place in a quiet, controlled environment with standardized instructions and safety precautions. Scores will be entered into the Gross Motor Ability Estimator software to generate interval-level total scores, allowing for sensitive tracking of changes in motor function over time. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
1-minute walk test | To assess functional walking capacity, participants will undergo the 1-minute walk test, performed on a marked 20-meter indoor course. Children will be instructed to walk as quickly and safely as possible without running, and the total distance covered in 60 seconds will be recorded. For participants who require orthoses or walkers, such assistive devices will be permitted during testing, consistent with real-world functionality. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Passive ankle joint range of motion | Passive ankle joint range of motion (ROM) will be measured using an isokinetic dynamometer. Each child will be seated with the knee fully extended, the ankle joint aligned with the dynamometer's rotational axis, and the foot securely fixed to a footplate. Passive dorsiflexion and plantar flexion will be conducted through full available range to determine ROM and passive torque. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Muscle morphological properties | Muscle morphological properties of the lower limbs will be assessed via ultrasonography using a 6-12 MHz linear transducer (Meinianda BX-5, Zibo, China). Images will be acquired for the rectus femoris, quadriceps femoris, and medial gastrocnemius on both lower limbs. Standardized anatomical landmarks will be used for probe placement, and muscle thickness and muscle fascicle length will be quantified offline by blinded assessors. | Baseline (week 0) and post-intervention (week 24) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pediatric Quality of Life Inventory | Psychological satisfaction and treatment engagement will be evaluated using the Pediatric Quality of Life Inventory (PedsQL™ 3.0 NMM), which is validated for children with chronic motor impairments (Iannaccone et al., 2009). This instrument includes child self-report and parent-proxy versions and assesses multiple dimensions including physical functioning, communication, and emotional well-being. Higher scores represent better perceived quality of life and satisfaction with daily function. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Years
Eligible Sexes
All
- 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.
- 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.
Hunan Normal UniversityStudy Responsible Party
Yang Zhang, Principal Investigator, Principle scientist, Hunan Normal University
Study Central Contact
Contact: Yang Zhang, PhD, 727-252-9687, [email protected]
Contact: Dinghua Liu, MS, 8618807486231
No location data.