About this trial
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 criteria
Qualifiers
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;
Disqualifiers
any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
skin issues that would prevent wearing the device;
pre-existing condition that caused exercise intolerance;
uncontrolled seizure disorder, spasticity or joint contracture that would interfere with walking;
Trial design
Treatments tested in this trial
- Pediatric Lower Limb Exoskeleton (Bambini Teens)
Treatment groups
Sponsors and collaborators
COSMO ROBOTICS CO., Ltd
Lead sponsor
Kessler Foundation
Collaborator