Motor DelayNCT03770832
Wearable Sensors and Video Recordings to Monitor Motor Development
An observational study of Motor Delay and Neurodevelopmental Disorders, run by Shirley Ryan AbilityLab at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Motor Delay, Neurodevelopmental Disorders, Developmental Disability
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Individuals at high risk of developing motor delays <24 months of age along with infants at low risk of developing motor delays.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
- Keywords
- Early Detection, Wearable Sensors, Computer Vision
- Medical subject headings
- Psychomotor Disorders, Neurodevelopmental Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants at Risk for Atypical Motor Development (high-risk) | Not described | |
| Infants Expected to Have Typical Motor Development (low-risk) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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])
Measured: 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])
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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]).
Measured: 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.
Measured: 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])
Measured: 1-2 weeks, 1 month, 9 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start29 Mar 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DelayStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, University of Illinois Chicago
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770832
- Sponsor's protocol ID
- SX04202018
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2018
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensors and Video Recording for Children (Birth to 24 Months) to Monitor Motor Development
- ClinicalTrials.gov ID
- NCT03770832
- Acronym / sponsor ID
- SX04202018
- Keywords
- Early Detection, Wearable Sensors, Computer Vision
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, University of Illinois Chicago
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants at Risk for Atypical Motor Development (high-risk) | – | – |
| Infants Expected to Have Typical Motor Development (low-risk) | – | – |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Individuals at high risk of developing motor delays <24 months of age along with infants at low risk of developing motor delays.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Three month clinical score estimation
Time frame: 3 months
Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.
Six month clinical score estimation
Time frame: 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
Time frame: 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])
Prediction of neuromotor outcome using sensor and video data from 6 month time-point
Time frame: 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])
6 secondary outcomes
Prediction of neuromotor outcome using General Movements Assessment (GMA) scores
Time frame: 1-2 weeks, 1 month, 3 months
Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores
Time frame: 6 months, 9 months, 1 year
Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores
Time frame: 6 months, 9 months, 1 year
Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores
Time frame: 1-2 weeks, 1 month, 3 months
Clinical score estimation
Time frame: 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
Time frame: 1-2 weeks, 1 month, 9 months, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Delay and Neurodevelopmental Disorders, run by Shirley Ryan AbilityLab at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three month clinical score estimation (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.