Clinical trial · Observational
PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
NCT04321200CI-TRIAL-00121295completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infant Development | — | UNRESOLVED | — |
| Neurodevelopmental Disorders | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile App | Other | — | UNRESOLVED |
| PANDA Gym | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cross-sectional-150 infants (atypical vs typical)
- description
- 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.
- interventionNames
- Diagnostic Test: PANDA Gym
- label
- Longitudinal cohort - 50 infants (atypical vs typical)
- description
- 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.
- interventionNames
- Diagnostic Test: PANDA Gym
- label
- Cross-sectional-1500 infants (atypical vs typical)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Months
- Maximum age
- 6 Months
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDNovak 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
- BACKGROUNDNoble 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
- BACKGROUNDEinspieler 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
- BACKGROUNDRydz D, Shevell MI, Majnemer A, Oskoui M. Developmental screening. J Child Neurol. 2005 Jan;20(1):4-21. doi: 10.1177/08830738050200010201. PMID 15791916