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

Recruiting

• Conditions: Neurodevelopmental Disorders; Pediatric ALL; Infant Development
• Interventions: Other: Mobile App; Diagnostic Test: PANDA Gym

• Registration Number: NCT04321200
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-11-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cross-sectional-1500 infants (atypical vs typical)	Mobile App	Arm (Study) 3: To develop a computer vision-based algorithm to quantify infant motor performance from a single-camera video. Here using video data from 1200 infants, plus those gathered from Arm 1 and Arm 2, we will extract pose data from single-camera video recordings and convert these into kinematic features and relevant scores needed to classify infant movement.
Cross-sectional-150 infants (atypical vs typical)	PANDA Gym	Arm (Study)1: To assess the concurrent validity of a multimodal instrumented gym with existing clinical tools. Here, using 150 infants, we will focus on converting data from an instrumented gym into estimates of the standard clinical tests.
Longitudinal cohort - 50 infants (atypical vs typical)	PANDA Gym	Arm (Study) 2: To discover the features related to long-term motor development. Here we will convert data collected longitudinally from 50 infants, using both instrumented gym and video recordings, into estimates standard clinical tests change over time and track features over developmental timescales.

Primary Outcome Measures

Name	Time	Method
Prechtl's General Movements Assessment (GMA) score	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.
Alberta Infant Motor Scale (AIMS) score	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	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	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	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	6 months	The regression R-squared resulting from a regression algorithm to predict the Alberta Infant Motor Scale (AIMS) score
The Test of Infant Motor Performance (TIMP) score	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.

Secondary Outcome Measures

Name	Time	Method
Toy contact frequency	6 month	Average # of voluntary contacts with the Toy - mean of with each arm and each leg
Average Path Length	6 months	The average path length of the center of pressure during a 2 minute session on the mat
Toy contact time	6 months	Average voluntary contact time with the Toy - including sum of contact time with each arm and each leg

Trial Locations

Locations (1)

Childrens Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States