Bambini Kids robotic exoskeleton to help children with cerebral palsy walk more naturally.
Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training in Children With Cerebral Palsy: A Randomized Clinical Trial
NA · COSMO ROBOTICS CO., Ltd · NCT07539389
We will test the Bambini Kids exoskeleton to see if it is safe and helps children ages 2 to 10 with cerebral palsy (GMFCS II–IV) improve walking and motor skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | COSMO ROBOTICS CO., Ltd (industry) |
| Locations | 1 site (Songpa, Seoul) |
| Trial ID | NCT07539389 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 10 with cerebral palsy classified GMFCS II–IV, with MMT 0–4 and MAS ≤3, adequate cognition and upper-limb function, and who meet the device's physical size and range-of-motion requirements.
Not a fit: Children who are outside the device's age/size limits, have severe skin lesions or uncontrolled medical issues, very high spasticity, or cannot tolerate or travel for repeated in-person sessions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could offer safer, more consistent high-intensity gait training that may improve walking ability and daily function for some children with cerebral palsy.
How similar studies have performed: Previous robot-assisted gait training studies in children with cerebral palsy have shown variable improvements in gait and motor outcomes, but evidence specifically for pediatric full lower-limb exoskeletons remains limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Songpa, Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy