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NOT YET RECRUITING
NCT07146932
NA

Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

Sponsor: COSMO ROBOTICS CO., Ltd

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

5 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-10

Completion Date

2026-01

Last Updated

2025-09-22

Healthy Volunteers

No

Interventions

DEVICE

Pediatric 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.

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States