Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

Overview

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.

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.

Primary outcome measures

• Device Safety [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Participant Usage and Treatment Compliance [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Feasibility of Usage [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Clinician Treatment Satisfaction [Time frame: End of intervention (~3 weeks, at final assessment)]

Secondary outcome measures (10)

• Physical Impairment - Blood Pressure [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Physical Impairment - Muscle Strength [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Physical Impairment - Joint Range of Motion [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Physical Impairment - Spasticity [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Endurance [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• 10-Meter Walk Test [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Timed Up and Go (TUG) [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Gait Mat Assessment [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Pediatric Balance Scale (PBS) [Time frame: Baseline to end of intervention (approximately 3 weeks)]
• Pediatric Quality of Life Inventory (PedsQL) [Time frame: Baseline to end of intervention (approximately 3 weeks)]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Kessler Foundation — West Orange

Identifiers

NCT: NCT07146932 · EXO-CIP-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗