RecruitingNCT04321200

PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Sponsor

University of Pennsylvania

Enrollment

1,700 participants

Start Date

Nov 1, 2020

Study Type

OBSERVATIONAL

Conditions

Pediatric ALL Neurodevelopmental Disorders Infant Development

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

Min Age: 0 MonthsMax Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This study is developing and testing an automated system (PANDA Gym) to assess motor development and detect early signs of brain-related movement disabilities in infants, using computer vision and sensors to track movement without requiring manual clinical testing. **You may be eligible if...** - Your baby is between 0 and 6 months old - Your baby falls into one of three groups: - Has a known early brain injury (such as hydrocephalus, oxygen deprivation at birth, brain bleeds, stroke, or periventricular leukomalacia) - Is a healthy baby with no known brain injury (control group) - Was born prematurely before 32 weeks with significant medical problems, feeding difficulties, or poor head control at 4 months **You may NOT be eligible if...** - Your baby is older than 6 months at the time of first enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTPANDA Gym

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.

OTHERMobile App

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.