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

Official title

Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability

Overview

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.

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. Ne
• 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, caregi

Primary outcome measures

• Prechtl's General Movements Assessment (GMA) score [Time frame: 1 months]
• Prechtl's General Movements Assessment (GMA) score [Time frame: 2 months]
• Prechtl's General Movements Assessment (GMA) score [Time frame: 3 months]
• Prechtl's General Movements Assessment (GMA) score [Time frame: 4 months]
• Prechtl's General Movements Assessment (GMA) score [Time frame: 5 months]
• The Test of Infant Motor Performance (TIMP) score [Time frame: 1 month]
• The Test of Infant Motor Performance (TIMP) score [Time frame: 2 months]
• The Test of Infant Motor Performance (TIMP) score [Time frame: 3 months]
• The Test of Infant Motor Performance (TIMP) score [Time frame: 4 months]
• Alberta Infant Motor Scale (AIMS) score [Time frame: 3 months]

Secondary outcome measures (6)

• Average Path Length [Time frame: 1 month]
• Average Path Length [Time frame: 6 months]
• Toy contact time [Time frame: 1 month]
• Toy contact time [Time frame: 6 months]
• Toy contact frequency [Time frame: 1 month]
• Toy contact frequency [Time frame: 6 month]

Eligibility 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)
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

United States · 1 center

• Childrens Hospital of Philadelphia — Philadelphia

Publications

• 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. PMID 23962350
• 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. PMID 22142216
• 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. PMID 27047429
• Rydz D, Shevell MI, Majnemer A, Oskoui M. Developmental screening. J Child Neurol. 2005 Jan;20(1):4-21. doi: 10.1177/08830738050200010201. PMID 15791916

Identifiers

NCT: NCT04321200 · 833180

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗