Wearable Sensors and Video Recordings to Monitor Motor Development

Wearable Sensors and Video Recording for Children (Birth to 24 Months) 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.

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopmental Disorders; Developmental Disability; Motor Delay

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Megan O'Brien, PhD; Phone Number: 312-238-2289; Email: mobrien02@sralab.org
• Study Contact Backup: Name: Imani Mann; Phone Number: 312-238-8221; Email: imann@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan AbilityLab
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals at high risk of developing motor delays <24 months of age along with infants at low risk of developing motor delays.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Infants at Risk for Atypical Motor Development (high-risk)
Infants Expected to Have Typical Motor Development (low-risk)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three month clinical score estimation	Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.	3 months
Six month clinical score estimation	Error between true clinical test scores and scores estimated from sensor and video data, assessed at 6 month time-point.	6 months
Prediction of neuromotor outcome using sensor and video data from 3 month time-point	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])	3 months
Prediction of neuromotor outcome using sensor and video data from 6 month time-point	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])	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of neuromotor outcome using General Movements Assessment (GMA) scores	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.	1-2 weeks, 1 month, 3 months
Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores	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.	6 months, 9 months, 1 year
Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores	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.	6 months, 9 months, 1 year
Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores	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]).	1-2 weeks, 1 month, 3 months
Clinical score estimation	Error between true clinical test scores and scores estimated from sensor and video data, assessed at each remaining time-point.	1-2 weeks, 1 month, 9 months, 1 year, 2 years
Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points	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])	1-2 weeks, 1 month, 9 months, 1 year, 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of neuromotor outcome using NICU Network Neurobehavioral Scale (NNNS) scores	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])	1 month

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: Northwestern University; University of Illinois at Chicago; Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Early Detection; Wearable Sensors; Computer Vision
• Additional Relevant MeSH Terms: Mental Disorders; Developmental Disabilities; Neurodevelopmental Disorders
• Other Study ID Numbers: SX04202018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No