Robotic Exoskeleton Gait Training for Children With Cerebral Palsy

NCT07049523 | Not Yet Recruiting

• 1 other identifier: 2025-506
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cerebral Palsy

Keywords

fascicle length; muscle volume; motor development; gait; rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (1)

• Pediatric Quality of Life Inventory

  Baseline (week 0), mid-point (week 12), and post-intervention (week 24)

Study Arms (2)

Regular rehabilitation

NO INTERVENTION

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.

Robotic-assisted gait training

EXPERIMENTAL

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.

Device: Robotic-assisted gait training

Interventions

Robotic-assisted gait training 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

Robotic-assisted gait training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Normal University: lead

Related Publications (1)

• Xia B, Mi N, Wen Z, Zhang Y. Protocol for the "stand the future" trial: robotic exoskeleton gait training for non-ambulatory children with spastic cerebral palsy. Front Neurol. 2025 Oct 15;16:1651913. doi: 10.3389/fneur.2025.1651913. eCollection 2025.

  PMID: 41170334 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bo Zhou, PhD

  Hunan Normal University, College of Physical Education

  STUDY DIRECTOR

Central Study Contacts

Yang Zhang, PhD

CONTACT

727-252-9687; yzhang68@crimson.ua.edu

Dinghua Liu, MS

CONTACT

8618807486231

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle scientist

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share