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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-10
SponsorCOSMO ROBOTICS CO., Ltd

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

30 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Asan Medical centerRecruiting05505, Songpa, SeoulSouth Korea

Sponsors and collaborators