Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

This study is looking at the Bambini Teens Exoskeleton, a wearable robotic device designed to help children with cerebral palsy (CP) move their legs and practice walking. The main goal is to see if this device is safe for children aged 5 to 14 years with CP and if physical therapists can easily use it for gait training. We want to make sure the device doesn't cause serious problems and that participants can successfully complete their training sessions. This study plans to enroll 20 children with CP who meet specific age and movement requirements. The current status of the study is unclear.

Study design: This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved: Participants will use the Bambini Teens Exoskeleton for gait training over approximately 3 weeks. They will need to comply with study procedures and follow-up requirements.
Compensation: Not stated in the trial record.
Follow-up: Safety, usage, and feasibility will be measured from the start of the study to the end of the intervention, which is approximately 3 weeks.

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Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

Not Yet Recruiting

NAAges 5–14InterventionalTreatment

COSMO ROBOTICS CO., Ltd

~20 participants

Updated 2025-09-22 on ClinicalTrials.gov

What's tested:Pediatric Lower Limb Exoskeleton (Bambini Teens)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Device Safety

Measured over Baseline to end of intervention (approximately 3 weeks)

+3 more outcomes measured

Conditions

Cerebral Palsy (CP)

Where it's being run

1 sites across 1 states

New Jersey1

Who to contact

Mohammed Huzien

[email protected]

973-968-6631

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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;

What this trial measures

Device SafetyBaseline to end of intervention (approximately 3 weeks)
Incidence of device-related serious adverse events (SAEs) and other adverse events (AEs) occurring during the intervention period, recorded in an adverse event log.
Participant Usage and Treatment ComplianceBaseline to end of intervention (approximately 3 weeks)
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.
Feasibility of UsageBaseline to end of intervention (approximately 3 weeks)
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.
Clinician Treatment SatisfactionEnd of intervention (~3 weeks, at final assessment)
Clinician satisfaction with the intervention, measured using a standardized FORM questionnaire completed by the treating physical therapist at the end of the intervention.

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