Robot suit gives hope to kids with cerebral palsy

NCT ID NCT07539389

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a robot suit called Bambini Kids that helps children with cerebral palsy move their legs in a more natural way. The goal is to see if it is safe and can improve walking and daily activities. About 30 children aged 2 to 10 will take part. The robot provides repetitive, high-intensity training that may be more effective than standard physical therapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects eligible for participation in this clinical investigation shall meet all of the following criteria. * Patient diagnosed with Cerebral Palsy * Age from 2 to 10 years old * Classified as Levels II to IV according to GMFCS * Manual Muscle Testing, MMT score of 0 to 4 * Modified Ashworth Scale, MAS score of 3 and under * Subjects with sufficient cognitive function to comply with study procedures * Subjects with adequate upper limb function required for device use and study procedures * Subjects who meet the physical requirements for use of the medical device as defined by the manufacturer Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for participation in the clinical investigation. * Subjects who do not meet the criteria of age, height, weight, body dimensions, or joint range of motion * Subjects with skin lesions, pressure sores, infections, or other conditions at area where device touches and makes difficult to use device * Classified as Levels V according to GMFCS * Subjects with severe spasticity (MAS \> 3), or those at risk of significant worsening of spasticity after training. * Subjects unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension) * Subjects with significant cardiovascular disease or a history of myocardial infarction within the past 6 months * Subjects with medical conditions that are contraindications for use of the medical device as defined by the manufacturer. * Subjects for whom weight-bearing, standing, or gait training is medically contraindicated (e.g., fractures, severe osteoporosis, severe joint deformity, or joint instability) * Subjects who have received treatments affecting muscle tone within the past 4 months, such as botulinum toxin injections or baclofen pump implantation * Subjects who experience adverse events or undesirable side effects during the clinical investigation that make continued participation difficult * Subjects whom the investigator judges to be unsuitable for participation or continuation in the clinical investigation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Asan Medical center

    RECRUITING

    Songpa, Seoul, 05505, South Korea

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