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.
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
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.
Parallel
Exoskeleton
DeviceThis 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.
Rehabilitation physical therapy
Other interventionThe 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)
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.
10-Meter Walk Test (10MWT)
The time required for the subject to walk 10 meters will be measured to calculate gait speed. This test provides a simple and reliable method for objectively assessing gait ability and functional mobility.
Guardian Satisfaction Assessment
Acceptability, usability, and perceived effectiveness of robot-assisted gait training will be assessed from the caregiver's perspective using a 7-point Likert scale. The minimum value is 1 and the maximum value is 7 . 1-point means "Not helpful at all", and 7-point means "Very helpful". The mean score across all items will be used as the total score. Individual item results will be reported separately, and internal consistency will be evaluated.
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