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Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

NCT07146932 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-22

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Kessler Foundation

    collaborator OTHER

  • COSMO ROBOTICS CO., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2025-12-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146932 on ClinicalTrials.gov