NCT04321200

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2020Jul 2026

First Submitted

Initial submission to the registry

December 17, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

5.7 years

First QC Date

December 17, 2019

Last Update Submit

September 22, 2025

Conditions

Pediatric ALLInfant DevelopmentNeurodevelopmental Disorders

Keywords

InfantsNeurodevelopmentDevelopmental DelaysElectronicsEarly InterventionSensory and MotorNICUNatural Play

Outcome Measures

Primary Outcomes (21)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Average Path Length

    1 month

  • Average Path Length

    6 months

  • Toy contact time

    1 month

  • Toy contact time

    6 months

  • Toy contact frequency

    1 month

  • +1 more secondary outcomes

Study Arms (3)

Cross-sectional-150 infants (atypical vs typical)

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.

Diagnostic Test: PANDA Gym

Longitudinal cohort - 50 infants (atypical vs typical)

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.

Diagnostic Test: PANDA Gym

Cross-sectional-1500 infants (atypical vs typical)

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.

Other: Mobile App

Interventions

PANDA GymDIAGNOSTIC_TEST

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.

Cross-sectional-150 infants (atypical vs typical)Longitudinal cohort - 50 infants (atypical vs typical)
Mobile AppOTHER

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.

Cross-sectional-1500 infants (atypical vs typical)

Eligibility Criteria

Age0 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study 1: 150 infants (75 with early brain injury, 75 Control). Age 1-6 months. Study 2: 50 infants (25 with early brain injury, 25 Control). Age 1 month. Study 3: 1200 infants (400 with EBI, 400 preterm without EBI/risk for future disability, 400 controls) from video data. Age 1-6 months. Infants without EBI/risk for future disability: Infants without known brain injuries, but with a history of preterm birth less than 32 week gestation, significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (4)

  • 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: 23962350BACKGROUND

  • 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: 22142216BACKGROUND

  • 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: 27047429BACKGROUND

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

    PMID: 15791916BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMental Disorders

Study Officials

  • Michelle J Johnson, PhD

    The University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle J Johnson, PhD

CONTACT

215-893-2665johnmic@pennmedicine.upenn.edu

Laura Prosser, PhD

CONTACT

215-590-2495ProsserL@email.chop.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

March 25, 2020

Study Start

November 1, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

US(1)