Bambini Kids robotic exoskeleton to help children with cerebral palsy walk more naturally.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the Bambini Kids pediatric exoskeleton to provide repetitive, high-intensity gait training for children with cerebral palsy. The device assists hip, knee, and ankle movements while participants also receive standard rehabilitation physical therapy. Children who meet age, size, and functional criteria (GMFCS II–IV, MMT 0–4, MAS ≤3) will receive device fitting and repeated in-person training sessions to monitor safety and changes in gait and motor performance. Outcomes will focus on safety events, device tolerability, and clinical measures of walking and motor function to inform real-world use in rehabilitation settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Asan Medical center
  Songpa, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Seung Hak Lee, Associate Professor
• Email: seunghak@gmail.com
• Phone: 82 + 02) 3010-3795

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Manual Therapy Before Neuromotor Rehab in Children with Cerebral Palsy

  In this pilot study, researchers test whether 30 minutes of lower-limb manual therapy before functional neuromotor therapy helps improve gait and motor performance in children with spastic cerebral palsy.

  Recruiting LIFE - Research and Care Institute - Santa Lucia IRCCS · Roma, Roma · NCT07902466

• Co-designed wrist-hand orthosis for children with neuromotor disorders

  In children aged 6 to 14 with neuromotor conditions after brain injury, researchers are testing a wrist-hand brace designed with input from the kids to see if it fits better and is easier to use than their current orthosis.

  Recruiting IRCCS Eugenio Medea · Bosisio Parini · NCT07861958

• Outcomes of tone-management surgery in children with spastic/dystonic quadriplegia

  This study tests how well intrathecal baclofen pumps and dorsal/ventral rhizotomy help improve movement, comfort, and daily life for kids with severe CP and high muscle tone.

  Recruiting Boston Children's Hospital · Boston, Massachusetts · NCT07817745

• Wearable eye tracking during bimanual tasks in children with cerebral palsy

  This study tests whether wearable eye-tracking glasses can reliably record eye movements while children with CP and typically developing peers perform two-handed tasks.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07806994

• Able Kids device: safer gait aid for kids with neurologic gait problems

  This study tests whether the ABLE Kids wearable exoskeleton can be safely used during a 10-session gait training program for children with neurological gait disorders or muscle weakness.

  Recruiting ABLE Human Motion S.L. · Girona, Girona · NCT07745712

• Dorsal Root Electrical Stimulation to Help Spasticity in Children with Cerebral Palsy

  This study tests whether adding dorsal root electrical stimulation during SDR surgery can lessen spasticity in children with cerebral palsy.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07715006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.