Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
Reason given: PI left NIH
Key facts
- Where
- Bethesda, United StatesSee the site
- Phase
- Phase 2
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesNo longer taking part
Trial details
- Who runs it
- National Institutes of Health Clinical Center (CC)
- Trial code
- NCT06593886
- Record updated
- 5 August 2025
- Original description
BabyG is a soft harness attached to a robotic system mounted overhead. While wearing the harness, the infant is free to move around a 10-by-10-foot play area with a padded floor. The harness helps support the infant s weight; it also slows any falls and catches the body before it hits the floor. BabyG can be adjusted to support 5% to 50% of the infant s weight.Read full original descriptionShow less
BabyG is a soft harness attached to a robotic system mounted overhead. While wearing the harness, the infant is free to move around a 10-by-10-foot play area with a padded floor. The harness helps support the infant s weight; it also slows any falls and catches the body before it hits the floor. BabyG can be adjusted to support 5% to 50% of the infant s weight.
Participants will be in the study for 24 weeks, including 12 weeks with BabyG training and 12 weeks without. Training will be 90 minutes per week: either two 45-minute sessions or three 30-minute sessions.
All participants will undergo tests during the 24 weeks such as:
A test to measure an infant s ability to perform tasks such as rolling, sitting, crawling, and walking.
A test to assess nerve function, movements, reflexes, posture, and muscle tone.
A test of brain activity while moving. The infant will be fitted with a snug cap with 64 electrodes. Then the infant will be placed in the BabyG harness and encouraged to take steps on a motorized treadmill. Their movements will be filmed.
Exclusion: Currently taking baclofen to reduce hypertonia; 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; History of surgery to the upper or lower extremities in the past 6 months; Seizure disorder that is not controlled by medication; An individual who meets any of the following criteria will be excluded from participation in this study:; Enrolled in another clinical trial during the study period that involves motor training or other intervention that could influence the outcomes of this study; Walk independently for 10 steps on a consistent basis with or without handheld assistive devices.
INCLUSION CRITERIA; In order to be eligible to participate in this study, an individual must meet all of the following criteria:; 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; A diagnosis of CP or high risk of CP; 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; Availability to return to NIH CC with parent or caregiver for training and assessment sessions.