Status:
WITHDRAWN
Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Cerebral Palsy
Physical Therapy Modalities
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
Brief Summary
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 sup...
Detailed Description
Study Description: This phase IIb randomized crossover trial will evaluate the effects of 12 weeks of mobility training while in a computer-controlled (robotic) unweighting system (BabyG) on motor de...
Eligibility Criteria
Inclusion
- 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.
- EXCLUSION CRITERIA
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- Currently taking baclofen to reduce hypertonia
- 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.
Exclusion
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06593886
Start Date
September 11 2024
End Date
September 11 2024
Last Update
August 5 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892