Using a robotic system to help infants with cerebral palsy move better

Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System

This study is testing whether a robotic system can help infants with cerebral palsy move better and improve their motor skills.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 5 Months to 18 Months
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06593886 on ClinicalTrials.gov

What this trial studies

This phase IIb randomized crossover trial evaluates the impact of a robotic unweighting system called BabyG on motor development in infants diagnosed with or at high risk for cerebral palsy. Over a 24-week period, participants will undergo 12 weeks of mobility training using BabyG, which supports the infant's weight and allows them to move freely in a safe environment. The study will assess motor skills, brain activity, and muscle size through various tests during both training and non-training periods. The goal is to determine the effectiveness of this innovative approach in enhancing mobility and motor function in affected infants.

Who should consider this trial

Good fit: Ideal candidates are infants aged 5 to 18 months diagnosed with cerebral palsy or at high risk for developing it.

Not a fit: Patients with secondary orthopedic, neuromuscular, or cardiovascular conditions unrelated to cerebral palsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve mobility and motor development in infants with cerebral palsy.

How similar studies have performed: Other studies have shown promise in using robotic systems for rehabilitation, indicating potential success for this novel approach.

Eligibility criteria

* INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. At least 5 months (adjusted for prematurity for those 37 weeks of gestation or less and is based on their due date) and no more than 18 months of age at enrollment
2. A diagnosis of CP or high risk of CP
3. Ability to push up on extended arms in prone for at least 10 seconds or demonstrates an interest in moving from one place to another by rolling, scooting or other means
4. Availability to return to NIH CC with parent or caregiver for training and assessment sessions.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Secondary orthopedic, neuromuscular or cardiovascular conditions unrelated to CP that would impede mobility such as hip dysplasia, clubfeet, uncorrected heart defect that affects exertion levels, brachial plexus palsy, among others
2. History of surgery to the upper or lower extremities in the past 6 months
3. Seizure disorder that is not controlled by medication
4. Currently taking baclofen to reduce hypertonia
5. Enrolled in another clinical trial during the study period that involves motor training or other intervention that could influence the outcomes of this study
6. Walk independently for 10 steps on a consistent basis with or without handheld assistive devices.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Diane L Damiano, Ph.D. — National Institutes of Health Clinical Center (CC)
• Study coordinator: Jesse H Matsubara

Conditions: Cerebral Palsy, Physical Therapy Modalities, Brain Injuries, Mobility, INFANTS, Robotic Unweighting System