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
COSMO ROBOTICS CO., Ltd
30 participants
Apr 13, 2026
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
Plain Language Summary
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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
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.
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)
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NCT07539389