Clinical trial NCT03770832: Wearable Sensors and Video Recordings to Monitor Motor Development
Official title: Wearable Sensors and Video Recording for Children (Birth to 24 Months) to Monitor Motor Development
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Motor Delay
Neurodevelopmental Disorders
Developmental Disability
Keywords: Early Detection
Wearable Sensors
Computer Vision
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Northwestern University
name: University of Illinois at Chicago
First posted: 2018-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Three month clinical score estimation
timeFrame: 3 months
measure: Six month clinical score estimation
timeFrame: 6 months
measure: Prediction of neuromotor outcome using sensor and video data from 3 month time-point
timeFrame: 3 months
measure: Prediction of neuromotor outcome using sensor and video data from 6 month time-point
timeFrame: 6 months
Secondary outcomes:
measure: Prediction of neuromotor outcome using General Movements Assessment (GMA) scores
timeFrame: 1-2 weeks, 1 month, 3 months
measure: Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores
timeFrame: 6 months, 9 months, 1 year
measure: Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores
timeFrame: 6 months, 9 months, 1 year
measure: Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores
timeFrame: 1-2 weeks, 1 month, 3 months
measure: Clinical score estimation
timeFrame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years
measure: Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points
timeFrame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years
Other outcomes:
measure: Prediction of neuromotor outcome using NICU Network Neurobehavioral Scale (NNNS) scores
timeFrame: 1 month
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: