PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorUniversity of Pennsylvania
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Hydrocephalus
Hypoxic-ischemic encephalopathy (HIE)
Periventricular leukomalacia (PVL)
Intraventricular hemorrhage (IVH)
Disqualifiers
None
Trial population
Study 1: 150 infants (75 with early brain injury, 75 Control). Age 1-6 months. Study 2: 50 infants (25 with early brain injury, 25 Control). Age 1 month. Study 3: 1200 infants (400 with EBI, 400 preterm without EBI/risk for future disability, 400 controls) from video data. Age 1-6 months. Infants without EBI/risk for future disability: Infants without known brain injuries, but with a history of preterm birth less than 32 week gestation, significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
PANDA Gym
Diagnostic testInfants 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.
Mobile App
Other interventionThe 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.
Treatment groups
1,700 Participants
are divided into 3 treatment groupsGroup A: Cross-sectional-150 infants (atypical vs typical)1 intervention
Group B: Longitudinal cohort - 50 infants (atypical vs typical)1 intervention
Group C: Cross-sectional-1500 infants (atypical vs typical)1 intervention
Trial outcomes
Primary outcomes
1
Prechtl's General Movements Assessment (GMA) score
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Time frame
1 months2
Prechtl's General Movements Assessment (GMA) score
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Time frame
2 months3
Prechtl's General Movements Assessment (GMA) score
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Time frame
3 months4
Prechtl's General Movements Assessment (GMA) score
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Time frame
4 monthsSecondary outcomes
1
Average Path Length
The average path length of the center of pressure during a 2 minute session on the mat
Time frame
1 month2
Average Path Length
The average path length of the center of pressure during a 2 minute session on the mat
Time frame
6 months3
Toy contact time
Average voluntary contact time with the Toy - including sum of contact time with each arm and each leg
Time frame
1 month4
Toy contact time
Average voluntary contact time with the Toy - including sum of contact time with each arm and each leg
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Source ClinicalTrials.gov