Wearable Sensors and Video Recordings to Monitor Motor Development

NCT03770832 | Active Not Recruiting

• 1 other identifier: SX04202018
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Motor Delay; Neurodevelopmental Disorders; Developmental Disability

Keywords

Early Detection; Wearable Sensors; Computer Vision

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

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

  1-2 weeks, 1 month, 3 months

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

  6 months, 9 months, 1 year

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

  6 months, 9 months, 1 year

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

  1-2 weeks, 1 month, 3 months

• Clinical score estimation

  1-2 weeks, 1 month, 9 months, 1 year, 2 years

Other Outcomes (1)

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

  1 month

Study Arms (2)

Infants at Risk for Atypical Motor Development (high-risk)

Infants Expected to Have Typical Motor Development (low-risk)

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Northwestern University: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (2)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Psychomotor Disorders; Neurodevelopmental Disorders; Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: March 29, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (2)