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