Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
COSMO ROBOTICS CO., Ltd
Summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP). The main questions it aims to answer are: * Is the Bambini Teens exoskeleton device safe and feasible as a gait training intervention for children with cerebral palsy, without resulting in a significant incidence of device-related serious adverse events? * Is it feasible for physical therapists to use the Bambini Teens exoskeleton as a gait training intervention for children with cerebral palsy, meaning participants will successfully complete the training sessions? * Will participants' mobility, specifically their self-selected walking speed, improve after receiving gait training using the Bambini Teens exoskeleton compared to baseline measurements? Researchers will compare participants' mobility measured at baseline to their mobility after the intervention to see if improvements occur. Participants will: * Complete 6 gait training sessions using the Bambini Pediatric Exoskeleton, monitored by a licensed physical therapist. * Each training session will be 30 minutes long, conducted 2-3 times per week for approximately 3 weeks. * Undergo evaluations at baseline and post-intervention (after approximately 3 weeks), with each evaluation session lasting approximately 2 hours. * May also participate in optional motor evaluations.
Eligibility
- Age range
- 5–14 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Between the age of 5 and 14 years and diagnosed with cerebral palsy; * have joint range of motion within normal functional limits for ambulation as determined by study staff; * Be able and willing to comply with study procedures, including follow-up requirements; * Patient cognitive status and ability to communicate must be at a level consistent with that required to participate in standard motor rehabilitation; * can follow directions as determined by study staff; * be able to physically fit into exoskeleton device; height from 110 to 160 cm (43 to 62 inches) and weighi…
Interventions
- DevicePediatric Lower Limb Exoskeleton (Bambini Teens)
The Bambini Teens Exoskeleton is a wearable robotic device developed to assist lower limb movement and facilitate gait training for pediatric patients with mobility impairments such as cerebral palsy. The device provides powered assistance at the hip, knee, and ankle joints, supports adjustable gait parameters, and is designed for use in clinical rehabilitation settings under professional supervision.
Location
- Kessler FoundationWest Orange, New Jersey