About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Exoskeleton
- Rehabilitation physical therapy
Treatment groups
Locations
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