RecruitingNot ApplicableNCT07539389

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

Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training in Children With Cerebral Palsy: A Randomized Clinical Trial


Sponsor

COSMO ROBOTICS CO., Ltd

Enrollment

30 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Exoskeleton and Rehabilitation physical therapy for people with cerebral palsy (cp). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExoskeleton

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.

OTHERRehabilitation physical therapy

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)


Locations(1)

Asan Medical center

Songpa, Seoul, South Korea

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NCT07539389


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