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

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help infants with cerebral palsy move more easily using a special device called BabyG. BabyG is a soft harness connected to a robot that supports the baby’s weight, allowing them to move around a safe play area without the risk of falling hard. The goal is to see if this device can improve the babies' ability to roll, sit, crawl, and walk over a period of 24 weeks, with 12 weeks of training using BabyG and 12 weeks without it.

To participate, infants need to be between 5 and 18 months old and have a diagnosis of cerebral palsy or be at high risk for it. They should be able to push up on their arms while lying on their stomach for at least 10 seconds or show interest in moving. The study involves weekly sessions where babies will do exercises and tests to check their movement and brain activity while using the BabyG harness. Parents or caregivers will need to bring their child to the study site for these sessions. It's important to note that some health conditions or recent surgeries might prevent a child from joining the study.

Gender

ALL

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.