Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
COSMO ROBOTICS CO., Ltd
Study ID
NCT07146932
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy (CP)

Eligibility Criteria

Sex
ALL
Age
5 Years - 14 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bambini Teens Exoskeleton Gait Training
    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.

Primary Outcome Measure

Device Safety [ Time Frame: Baseline to end of intervention (approximately 3 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Mohammed Huzien
[email protected]
973-968-6631

Find similar trials in West Orange, NJ

By research site
Kessler Foundation· West Orange, NJ

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