Clinical Trial

Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

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Record status
This record was last updated September 22, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-21.
Trial Details
NCT Number NCT07146932
Lead Sponsor COSMO ROBOTICS CO., Ltd
Collaborators: Kessler Foundation
Conditions Cerebral Palsy (CP)
Enrollment 20 participants
Start Date 2025-10
Primary Completion 2025-12 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-22