Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy

NCT07539389 | Recruiting

• 1 other identifier: EXO-CIP-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy (CP) is a common cause of gait impairment in children, leading to limitations in mobility and daily activities. Although conventional physical therapy is widely used, it has limitations in delivering consistent and intensive training. Robot-assisted gait training (RAGT) has emerged as a promising approach to provide repetitive, high-intensity, and task-specific training, with potential benefits in gait function and motor performance. The Bambini Kids exoskeleton is a pediatric robotic device designed to assist lower-limb movements, including hip, knee, and ankle joints, to facilitate more natural gait patterns. This study aims to evaluate the safety and clinical performance of Bambini Kids in children with cerebral palsy and to generate clinical evidence to support its use in real-world rehabilitation settings.

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure 88 (GMFM-88)

  The Gross Motor Function Measure (GMFM) is a standardized observational assessment tool used to evaluate changes in gross motor function over time in children with cerebral palsy, consisting of a total of 88 items. Functional performance is assessed across five domains: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping. The score for each domain is calculated and expressed as a percentage.

  Outcomes will be assessed at week 0, week 2, and week 4 for both treatment group and control group.

Secondary Outcomes (2)

• 10-Meter Walk Test (10MWT)

  Outcomes will be assessed at week 0, week 2, and week 4 for both treatment group and control group.

• Guardian Satisfaction Assessment

  Outcomes will be assessed at week 4 for both treatment group and control group.

Study Arms (2)

Exoskeleton group

EXPERIMENTAL

Apply robot-assisted gait training (RAGT) for three sessions per week, a total of 12 sessions.

Device: Exoskeleton

Conventional Therapy group

ACTIVE COMPARATOR

Apply conventional therapy for three sessions per week, a total of 12 sessions.

Other: Rehabilitation physical therapy

Interventions

Exoskeleton DEVICE

This device is a powered exoskeleton intended to be worn on lower limbs affected by paralysis or weakness. It is designed to directly actuate the user's lower limb joints via integrated motors to assist or enable gait. The subject will have intervention of robot-assisted gait training (RAGT) using Bambini Kids (Cosmo Robotics Co., Ltd) for three sessions per week, 30 minutes per session, for 4 weeks.

Also known as: Bambini Kids

Exoskeleton group

Rehabilitation physical therapy OTHER

The subject will have intervention of one-on-one gait rehabilitation therapy with physical therapist for the same duration as treatment group (three sessions per week, 30 minutes per session, for 4 weeks)

Conventional Therapy group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects eligible for participation in this clinical investigation shall meet all of the following criteria.
• Patient diagnosed with Cerebral Palsy
• Age from 2 to 10 years old
• Classified as Levels II to IV according to GMFCS
• Manual Muscle Testing, MMT score of 0 to 4
• Modified Ashworth Scale, MAS score of 3 and under
• Subjects with sufficient cognitive function to comply with study procedures
• Subjects with adequate upper limb function required for device use and study procedures
• Subjects who meet the physical requirements for use of the medical device as defined by the manufacturer

You may not qualify if:

• Subjects meeting any of the following criteria are not eligible for participation in the clinical investigation.
• Subjects who do not meet the criteria of age, height, weight, body dimensions, or joint range of motion
• Subjects with skin lesions, pressure sores, infections, or other conditions at area where device touches and makes difficult to use device
• Classified as Levels V according to GMFCS
• Subjects with severe spasticity (MAS \> 3), or those at risk of significant worsening of spasticity after training.
• Subjects unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension)
• Subjects with significant cardiovascular disease or a history of myocardial infarction within the past 6 months
• Subjects with medical conditions that are contraindications for use of the medical device as defined by the manufacturer.
• Subjects for whom weight-bearing, standing, or gait training is medically contraindicated (e.g., fractures, severe osteoporosis, severe joint deformity, or joint instability)
• Subjects who have received treatments affecting muscle tone within the past 4 months, such as botulinum toxin injections or baclofen pump implantation
• Subjects who experience adverse events or undesirable side effects during the clinical investigation that make continued participation difficult
• Subjects whom the investigator judges to be unsuitable for participation or continuation in the clinical investigation.

Sponsors & Collaborators

• COSMO ROBOTICS CO., Ltd: lead

Study Sites (1)

Asan Medical center

Songpa, Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Seung Hak Lee, Associate Professor

CONTACT

82 + 02) 3010-3795; seunghak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

KR (1)