PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
University of Pennsylvania
1,700 participants
Nov 1, 2020
OBSERVATIONAL
Conditions
Summary
Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.
Eligibility
Inclusion Criteria11
- Infants, male and female, between 0-6 months (Infants older than 6 months before initial enrollment will be excluded).
- Infants with early brain injury (EBI):
- Hydrocephalus
- Hypoxic-ischemic encephalopathy (HIE)
- Periventricular leukomalacia (PVL)
- Intraventricular hemorrhage (IVH)
- Stroke
- Healthy infants (controls):
- o No history of early brain injury (EBI)
- Infants without EBI/risk for future disability:
- Infants without known brain injuries, but with a history of preterm birth less than 32-week gestation with significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.
Interventions
Infants will lie supine on a flat surface and will be placed in the PANDA gym where they either move by themselves or will interact with an instrumented toy. We will collect video, mat, and toy data from PANDA gym under two conditions: 1) infants playing supine without a toy and 2) infants reach, grasp and kick of the new PANDA toy. A test session will proceed as follows: The infant will be placed on his or her back at a predetermined position on the gym mat for the 2-minute no toy condition. Next, the toy will be given to the baby and adjusted for the infant to reach or kick. A caregiver will be seated at the head of the baby (out of a baby's sight) to provide comfort if needed. Testing will be done in NICU or at daycare or the rehabilitation robotics lab at University of Pennsylvania.
The parent or legal guardian will be consented first via the virtual rounding mobile app. They will also be asked to fill out general surveys including, a demographic survey, and a case report form, and a user feedback survey that provides relevant information, on both the family's and infant's medical history and experience. (see the flow-chart for the app). Within the caregiver survey, we will request the pediatrician (or primary care physician) name. We believe that with the baby name, caregiver name, zip code, and physician name, we will be able to locate the physician if needed. Parents or legal guardians or the research will be asked to collect video via the MOBILE app. They will be instructed to ensure that the infant lies supine in no more than one-layer of tight-fitting clothing (i.e. infant onesie) while calm and awake. In all cases, we will have video recordings of the baby. They will be asked to upload the video to the app.
Locations(1)
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NCT04321200