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

Pediatric ALL Clinical Trial

Official title:

Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321200
• Other study ID #: 833180
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Michelle J Johnson, PhD
• Phone: 215-893-2665
• Email: johnmic[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

For children with neurodevelopmental disabilities, early treatment in the first year of life improves long-term outcomes. However, the investigators are currently held back by inadequacies of available clinical tests to measure and predict impairment. Existing tests are hard to administer, require specialized training, and have limited long-term predictive value. There is a critical need to develop an objective, accurate, easy-to-use tool for the early prediction of long-term physical disability. The field of pediatrics and infant development would greatly benefit from a quantitative score that would correlate with existing clinical measures used today to detect movement impairments in very young infants. To realize a new generation of tests that will be easy to administer, the investigators will obtain large datasets of infants playing in an instrumented gym or simply being recorded while moving in a supine posture. Video and sensor data analyses will convert movement into feature vectors based on our knowledge of the problem domain. Our approach will use machine learning to relate these feature vectors to currently recommended clinical tests or other ground truth information. The power of this design is that algorithms can utilize many aspects of movement to produce the relevant scores.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development
• Neurodevelopmental Disorders
• Pediatric ALL

Intervention

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.

Locations

Country	Name	City	State
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (4)

Einspieler C, Bos AF, Libertus ME, Marschik PB. The General Movement Assessment Helps Us to Identify Preterm Infants at Risk for Cognitive Dysfunction. Front Psychol. 2016 Mar 22;7:406. doi: 10.3389/fpsyg.2016.00406. eCollection 2016. — View Citation

Noble Y, Boyd R. Neonatal assessments for the preterm infant up to 4 months corrected age: a systematic review. Dev Med Child Neurol. 2012 Feb;54(2):129-39. doi: 10.1111/j.1469-8749.2010.03903.x. Epub 2011 Dec 5. — View Citation

Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21. — View Citation

Rydz D, Shevell MI, Majnemer A, Oskoui M. Developmental screening. J Child Neurol. 2005 Jan;20(1):4-21. doi: 10.1177/08830738050200010201. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 months
Primary	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.	2 months
Primary	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.	3 months
Primary	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.	4 months
Primary	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.	5 months
Primary	The Test of Infant Motor Performance (TIMP) score	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.	1 month
Primary	The Test of Infant Motor Performance (TIMP) score	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.	2 months
Primary	The Test of Infant Motor Performance (TIMP) score	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.	3 months
Primary	The Test of Infant Motor Performance (TIMP) score	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.	4 months
Primary	Alberta Infant Motor Scale (AIMS) score	The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.	3 months
Primary	Alberta Infant Motor Scale (AIMS) score	The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.	4 months
Primary	Alberta Infant Motor Scale (AIMS) score	The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.	5 months
Primary	Alberta Infant Motor Scale (AIMS) score	The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.	6 months
Primary	Hammersmith Infant Neurological Examination (HINE) score	The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.	1 months
Primary	Hammersmith Infant Neurological Examination (HINE) score	The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.	2 months
Primary	Hammersmith Infant Neurological Examination (HINE) score	The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.	3 months
Primary	Hammersmith Infant Neurological Examination (HINE) score	The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.	4 months
Primary	Hammersmith Infant Neurological Examination (HINE) score	The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.	5 months
Primary	Ability to predict The Hammersmith Infant Neurological Examination (HINE) score	The regression R-squared resulting from regression algorithm to predict the Test of Infant Motor Performance (TIMP)	6 months
Primary	Ability to predict The Test of Infant Motor Performance (TIMP) score	The regression R-squared resulting from regression algorithm to predict the Test of Infant Motor Performance (TIMP)	6 months
Primary	Ability to predict the Alberta Infant Motor Scale (AIMS) score	The regression R-squared resulting from a regression algorithm to predict the Alberta Infant Motor Scale (AIMS) score	6 months
Secondary	Average Path Length	The average path length of the center of pressure during a 2 minute session on the mat	1 month
Secondary	Average Path Length	The average path length of the center of pressure during a 2 minute session on the mat	6 months
Secondary	Toy contact time	Average voluntary contact time with the Toy - including sum of contact time with each arm and each leg	1 month
Secondary	Toy contact time	Average voluntary contact time with the Toy - including sum of contact time with each arm and each leg	6 months
Secondary	Toy contact frequency	Average # of voluntary contacts with the Toy - mean of with each arm and each leg	1 month
Secondary	Toy contact frequency	Average # of voluntary contacts with the Toy - mean of with each arm and each leg	6 month