NCT04321200 · University of Pennsylvania
PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
PANDA 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.
OTHER
Mobile 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.
Primary outcome measures
Prechtl's General Movements Assessment (GMA) score
Time frame: 1 months
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.
Prechtl's General Movements Assessment (GMA) score
Time frame: 2 months
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.
Prechtl's General Movements Assessment (GMA) score
Time frame: 3 months
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.
Prechtl's General Movements Assessment (GMA) score
Time frame: 4 months
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.
Prechtl's General Movements Assessment (GMA) score
Time frame: 5 months
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.
The Test of Infant Motor Performance (TIMP) score
Time frame: 1 month
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
The Test of Infant Motor Performance (TIMP) score
Time frame: 2 months
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
The Test of Infant Motor Performance (TIMP) score
Time frame: 3 months
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
The Test of Infant Motor Performance (TIMP) score
Time frame: 4 months
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
Alberta Infant Motor Scale (AIMS) score
Time frame: 3 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Alberta Infant Motor Scale (AIMS) score
Time frame: 4 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Alberta Infant Motor Scale (AIMS) score
Time frame: 5 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Alberta Infant Motor Scale (AIMS) score
Time frame: 6 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Hammersmith Infant Neurological Examination (HINE) score
Time frame: 1 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
Time frame: 2 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
Time frame: 3 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
Time frame: 4 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
Time frame: 5 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Ability to predict The Hammersmith Infant Neurological Examination (HINE) score
Time frame: 6 months
The regression R-squared resulting from regression algorithm to predict the Test of Infant Motor Performance (TIMP)
Ability to predict The Test of Infant Motor Performance (TIMP) score
Time frame: 6 months
The regression R-squared resulting from regression algorithm to predict the Test of Infant Motor Performance (TIMP)
Ability to predict the Alberta Infant Motor Scale (AIMS) score
Time frame: 6 months
The regression R-squared resulting from a regression algorithm to predict the Alberta Infant Motor Scale (AIMS) score
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- 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.
Where
- Philadelphia, Pennsylvania
Collaborators
Children's Hospital of Philadelphia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations