NCT07539389 Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy

Eligibility & Interventions

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This trial targets 30 participants in total. It began in 2026-04-13 with a primary completion date of 2026-12-31.

Brief 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 Criteria

Inclusion Criteria: 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 Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for participation in the clinical investigation. * 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. * Subjects unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension) * Subjects with significant cardiovascular disease or a history of myocardial infarction within the past 6 months * Subjects with medical conditions that are contraindications for use of the medical device as defined by the manufacturer. * Subjects for whom weight-bearing, standing, or gait training is medically contraindicated (e.g., fractures, severe osteoporosis, severe joint deformity, or joint instability) * Subjects who have received treatments affecting muscle tone within the past 4 months, such as botulinum toxin injections or baclofen pump implantation * Subjects who experience adverse events or undesirable side effects during the clinical investigation that make continued participation difficult * Subjects whom the investigator judges to be unsuitable for participation or continuation in the clinical investigation.

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