Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

NCT07146932 | Not Yet Recruiting FDA Device

• 1 other identifier: EXO-CIP-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

Bambini Teens; Cerebral Palsy; Exoskeleton; ExoAtlet; Cosmo Robotics; Wearable Robotic Devices

Outcome Measures

Primary Outcomes (4)

• Device Safety

  Incidence of device-related serious adverse events (SAEs) and other adverse events (AEs) occurring during the intervention period, recorded in an adverse event log.

  Baseline to end of intervention (approximately 3 weeks)

• Participant Usage and Treatment Compliance

  Proportion of participants who complete all six planned gait training sessions under the supervision of a licensed physical therapist. Completion will be verified by session attendance and completion records.

  Baseline to end of intervention (approximately 3 weeks)

• Feasibility of Usage

  Proportion of participants for whom the treating physical therapist successfully fits the device and records session-specific device settings, as documented in the session logs.

  Baseline to end of intervention (approximately 3 weeks)

• Clinician Treatment Satisfaction

  Clinician satisfaction with the intervention, measured using a standardized FORM questionnaire completed by the treating physical therapist at the end of the intervention.

  End of intervention (~3 weeks, at final assessment)

Secondary Outcomes (10)

• Physical Impairment - Blood Pressure

  Baseline to end of intervention (approximately 3 weeks)

• Physical Impairment - Muscle Strength

  Baseline to end of intervention (approximately 3 weeks)

• Physical Impairment - Joint Range of Motion

  Baseline to end of intervention (approximately 3 weeks)

• Physical Impairment - Spasticity

  Baseline to end of intervention (approximately 3 weeks)

• Endurance

  Baseline to end of intervention (approximately 3 weeks)

Study Arms (1)

Bambini Teens Exoskeleton Gait Training

EXPERIMENTAL

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.

Device: Pediatric Lower Limb Exoskeleton (Bambini Teens)

Interventions

Pediatric Lower Limb Exoskeleton (Bambini Teens) DEVICE

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.

Bambini Teens Exoskeleton Gait Training

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• COSMO ROBOTICS CO., Ltd: lead
• Kessler Foundation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Mohammed Huzien

CONTACT

973-968-6631; mhuzien@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)