Wearable Sensors and Video Recordings to Monitor Motor Development

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770832
• Other study ID #: SX04202018
• Status: Recruiting
• Start date: March 29, 2019
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Shirley Ryan AbilityLab
• Contact: Megan O'Brien, PhD
• Phone: 312-238-2289
• Email: mobrien02[@]sralab.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Disabilities
• Developmental Disability
• Motor Delay
• Neurodevelopmental Disorders

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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