Wearable Sensors and Video Recordings to Monitor Motor Development

• Conditions: Neurodevelopmental Disorders; Motor Delay; Developmental Disability

• Registration Number: NCT03770832
• Lead Sponsor: Shirley Ryan AbilityLab

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Study Start: 2019-03-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six month clinical score estimation	6 months	Error between true clinical test scores and scores estimated from sensor and video data, assessed at 6 month time-point.
Prediction of neuromotor outcome using sensor and video data from 3 month time-point	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 \[PDMS-2\])
Three month clinical score estimation	3 months	Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.
Prediction of neuromotor outcome using sensor and video data from 6 month time-point	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 Outcome Measures

Name	Time	Method
Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores	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 \[PDMS-2\]).
Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores	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.
Clinical score estimation	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.
Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points	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 \[PDMS-2\])
Prediction of neuromotor outcome using General Movements Assessment (GMA) scores	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.
Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores	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.

Trial Locations

Locations (2)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States