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

NCT07539389 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-20

No results posted yet for this study

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)

Interventions

DEVICE

Exoskeleton

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.

OTHER

Rehabilitation 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)

Sponsors & Collaborators

  • COSMO ROBOTICS CO., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539389 on ClinicalTrials.gov