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NCT Number: NCT03770832

Wearable Sensors and Video Recordings to Monitor Motor Development

The objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Motor Delay Developmental Disabilities Developmental Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Shirley Ryan AbilityLab, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals identified as potentially at risk of abnormal motor development due to a risk factor (for example, prematurity, neonatal hypoxic ischemic encephalopathy, or neonatal stroke) OR control individuals for whom normal motor development is expected.
  • Age: < 24 months of age
  • Legal guardian able and willing to give written consent and comply with study procedures.
  • In case of multiple pregnancies, only one child selected at random will participate in the research activities. Study staff will have no influence over the selection, besides any known medical condition automatically excluding the baby as listed in our exclusion criteria.

Exclusion criteria

  • Any open wound or skin breakdown on the limbs or upper torso.
  • Missing or incomplete limbs (such as from amputation or congenital limb defects)
  • Legal guardian unable to give written consent and comply with study procedures.

Treatment and study plan

Primary outcomes

  1. Three month clinical score estimation

    Time frame: 3 months

    Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.

  2. Six month clinical score estimation

    Time frame: 6 months

    Error between true clinical test scores and scores estimated from sensor and video data, assessed at 6 month time-point.

  3. Prediction of neuromotor outcome using sensor and video data from 3 month time-point

    Time frame: 3 months

    Sensitivity and specificity of algorithm (trained on sensor and video data from the 3 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])

  4. Prediction of neuromotor outcome using sensor and video data from 6 month time-point

    Time frame: 6 months

    Sensitivity and specificity of algorithm (trained on sensor and video data from the 6 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])

Secondary outcomes

  1. Prediction of neuromotor outcome using General Movements Assessment (GMA) scores

    Time frame: 1-2 weeks, 1 month, 3 months

    Sensitivity and specificity of GMA scores (taken at 1-2 weeks, 1 month, 3 months) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The GMA is an observational exam where an infant's spontaneous movements are scored as atypical or normal for their age.

  2. Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores

    Time frame: 6 months, 9 months, 1 year

    Sensitivity and specificity of AIMS scores (taken at 6 months, 9 months, 1 year) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The AIMS is a norm-referenced observational assessment with a minimum score of 0 and a maximum score of 58. Higher scores indicate better motor performance on the assessment.

  3. Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores

    Time frame: 6 months, 9 months, 1 year

    Sensitivity and specificity of HINE scores (taken at 6 months, 9 months, 1 year) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]). The HINE is a neurological exam with a minimum score of 0 and a maximum score of 78. Higher scores indicate better performance on the assessment.

  4. Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores

    Time frame: 1-2 weeks, 1 month, 3 months

    Sensitivity and specificity of TIMP scores (taken at 1-2 weeks, 1 month, 3 months) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2]).

  5. Clinical score estimation

    Time frame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years

    Error between true clinical test scores and scores estimated from sensor and video data, assessed at each remaining time-point.

  6. Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points

    Time frame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years

    Sensitivity and specificity of algorithm (trained on sensor and video data from the remaining time-points) to predict neuromotor outcome at 2 years (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])

Other outcomes

  1. Prediction of neuromotor outcome using NICU Network Neurobehavioral Scale (NNNS) scores

    Time frame: 1 month

    Sensitivity and specificity of NNNS scores (taken at 1 month) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition [PDMS-2])

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Northwestern University
  • University of Illinois at Chicago

Registry information

Official study title

Wearable Sensors and Video Recording for Children (Birth to 24 Months) to Monitor Motor Development

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2018
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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