Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

COSMO ROBOTICS CO., Ltd

Status: Not yet enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Device: Pediatric Lower Limb Exoskeleton (Bambini Teens)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07146932

EXO-CIP-002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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 weighing up less than 65 kg (145 lbs);
• be able to walk 10 meters with the aid of a walking assistive device and/or a single human assistant;
• bilateral lower limb spasticity that allows lower limb range of motion within the device.

Exclusion criteria

• 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;
• neuromuscular, neurological, cardiovascular or orthopedic pathologies that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs;
• severe spasticity (Modified Ashworth Scale = or > 3);
• hip extension range of motion < 0 degrees, knee flexion contracture > 20 degrees, knee valgus > 40 degrees, 2 or more fractures within the past year, hip subluxation (> 40% migration),
• existing Baclofen pump, and/or Botox injections within the past 4 months of study enrollment;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Bambini Teens Exoskeleton Gait Training

Experimental group

Description:

Participants in this arm will receive gait training using the Bambini Teens Exoskeleton. Each participant will complete six training sessions, each lasting 30 minutes, conducted 2-3 times per week over approximately 3 weeks.

Treatment:

Device: Pediatric Lower Limb Exoskeleton (Bambini Teens)