Motor DelayNCT07866495
Wearable Sensor Toolkit for Infant Motor Development
An observational study of Motor Delay and Infant Development, run by Shirley Ryan AbilityLab at 2 sites in United States.
Trial summary
The purpose of this study is to develop and test a fully automated, wireless sensor-based toolkit for infants that can capture early indicators (0-3 months) of motor deficits during activities of daily life and track motor development over the course of one year. Read more about this study
- Who is it for?
- Ages 0 days to 52 weeks
- Conditions the study is for
- Motor Delay, Infant Development, Motor Development of Premature Infants
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Sep 2031
- 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 days to 52 weeks
- All sexes
- No healthy volunteers
- Child
Study population: infants who are at risk of motor or other developmental delay
Who may be able to join
- The study population comprises infants who are at risk of motor or other developmental delay. "At-risk" is defined as having been admitted to the NICU admission and qualifying for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- BW <1500 grams OR
- Disorders of the central nervous system
- Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
- HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
- includes "at risk for HIE" with 10-minute Apgar <7 plus pH<7.15 or base deficit >/=12.
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- Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
- Cramped synchronous movements at term PMA (post-menstrual age) OR
- Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at <32 weeks of gestation.
- AND
- Medically stable (as determined by their neonatologist) AND able to begin study procedures between 34-48 weeks PMA.
Who cannot join
- Open wounds, skin condition precluding sensor placement
- Immune deficiencies requiring protective isolation
- Limb reduction defects
- Followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
- Bleeding disorders or ongoing need for anticoagulation
- Palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
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- Known visual impairment at the time of enrollment
- DCFS custody
- No English-speaking caregivers
- Any other condition that would preclude participation in the study, as determined by the PI
- Previously enrolled in competing randomized trial with developmental outcome variables
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Shirley Ryan Abilitylab
Chicago, Illinois, 60611
Megan O'Brien, PhD, (312) 238-2289, mobrien02@sralab.org
Anushua Banerjee, 312-238-7721, abanerjee@sralab.org
University of Illinois at Chicago
Chicago, Illinois, 60612
Nishant Srinivasan, MD, 312-996-4185, srinis@uic.edu
Zaynab Kadhem, 312-355-4038, zkadhe2@uic.edu
About this study
Official title: A Wearable Sensor Toolkit for Automated Home Evaluations of Infant Motor Development
The purpose of this study is to develop and test a fully automated, wireless sensor-based toolkit for infants that can capture early indicators (0-3 months) of motor deficits during activities of daily life and track motor development over the course of one year.
The investigators expect that the participating child will be in this research study for up to 12-24 months corrected-age depending on which group the participating child is recruited into.
Read more
The main benefit of being in this study is to help monitor the participating child's motor development.
The investigators will place up to 6 sensors on the participants body and head to observe the participants child's movement. Caregivers will also be trained to place the sensors. The sensors will send movement information wirelessly to an iPad or smartphone, using Bluetooth technology.
Read the detailed description
Study visits will include clinical assessments and sensor data collection sessions to test and monitor their motor development over time. The frequency and length of study visits will vary depending on what group the participant is recruited into.
Participating children in the Toolkit Development cohort (Aim 1) will complete up to 7 study visits from birth to 3 months corrected age. Sensor visits will occur biweekly and assessment visits will occur monthly. Follow-up visits will be completed at 12 and 24-months corrected age. Data from this cohort will be used to develop and internally test the toolkit (Aim 2).
Participating children in the Toolkit Validation cohort (Aim 3) will complete biweekly sensor visits from birth to 3 months corrected age (up to 7 visits). In this cohort, the child may continue testing monthly from 4-11 months corrected age ("Surveillance group", up to 8 visits; see below). A follow-up visit will be completed at 12-months corrected age for all participants in the Toolkit Validation cohort. Data from this cohort will be used to validate and refine the toolkit for optimized performance and clinical utility. Children will be assigned to the Surveillance group under this aim, to continue monthly sensor and assessment visits from 4-11 months corrected age, if either of the following occur: (1) The toolkit disagrees with the specialist assessment at 3-months corrected age. (2) If the toolkit identifies the participating child as at risk for motor deficits any time between birth and 3-months corrected age.
For any cohort, the study team will place up to 6 sensors on the child's body and head to observe the participating child's movement. Skin checks will be performed before and after placing the sensors. These visits will take place in participants' home and in the community. There are two components of the sensor visits: Observed Activities and Free-Living Activities. During Observed Activities, the study team will observe the caregiver and participating child during any common daily activities for at least 30 minutes, targeting up to 60 minutes. The study team may ask caregivers to support their child as needed during these activities. During Free-Living Activities, the caregiver will continue to monitor and log their child's activities and behaviors for up to 12 hours. Caregivers will be given a GoPro camera and tripod to record their child's activities inside and outside the home, to their comfort. Caregivers will also be given a manual log to document any activities that the caregivers do not want or are not able to capture on video. The study team will not be present throughout this component. The sensors, log, and GoPro will be picked up the next day or at families earliest convenience
- Conditions
- Motor Delay, Infant Development, Motor Development of Premature Infants, Motor Coordination or Function; Developmental Disorder
- Keywords
- Infant, Motor Development, Home Visits, Infant Motor Delay, 0-3 Months, Risk of Motor Delay in Infants
- Medical subject headings
- Psychomotor 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 0-3 Months Old at Risk for Motor Delay (Aim 1) | Not described | |
| Infants 0-3 Months Old at Risk for Motor Delay Surveillance Group (Aim 3) | Not described | |
| Infants 0-3 Months Old at Risk for Motor Delay Non-Surveillance Group (Aim 3) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month Screening Performance (Aims 1-2, Toolkit Development cohort)
Screening performance of the toolkit at 3 months (internal validation)
Measured: 3 months
3-month Screening Performance (Aim 3; Toolkit Validation cohort)
Screening performance of the toolkit at 3 months (external validation)
Measured: 3 months
Secondary outcomes (2)
12-month Screening Performance (Aims 1-2; Toolkit Development cohort)
Screening performance of the toolkit at 12 months (internal validation)
Measured: 12 months
12-month Screening Performance (Aim 3; Toolkit Validation cohort)
Screening performance of the toolkit at 12 months (external validation)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (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.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois at Chicago
- Responsible party
- Principal investigator, Megan O'Brien, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866495
- Sponsor's protocol ID
- STU00226073
- Other IDs
- R01HD117997
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable Sensor Toolkit for Automated Home Evaluations of Infant Motor Development
- ClinicalTrials.gov ID
- NCT07866495
- Acronym / sponsor ID
- STU00226073
- Conditions
- Motor Delay, Infant Development, Motor Development of Premature Infants, Motor Coordination or Function; Developmental Disorder
- Keywords
- Infant, Motor Development, Home Visits, Infant Motor Delay, 0-3 Months, Risk of Motor Delay in Infants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois at Chicago
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 8 Oct 2026 (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 purpose of this study is to develop and test a fully automated, wireless sensor-based toolkit for infants that can capture early indicators (0-3 months) of motor deficits during activities of daily life and track motor development over the course of one year.
The investigators expect that the participating child will be in this research study for up to 12-24 months corrected-age depending on which group the participating child is recruited into.
The main benefit of being in this study is to help monitor the participating child's motor development.
The investigators will place up to 6 sensors on the participants body and head to observe the participants child's movement. Caregivers will also be trained to place the sensors. The sensors will send movement information wirelessly to an iPad or smartphone, using Bluetooth technology.
Detailed description
Study visits will include clinical assessments and sensor data collection sessions to test and monitor their motor development over time. The frequency and length of study visits will vary depending on what group the participant is recruited into.
Participating children in the Toolkit Development cohort (Aim 1) will complete up to 7 study visits from birth to 3 months corrected age. Sensor visits will occur biweekly and assessment visits will occur monthly. Follow-up visits will be completed at 12 and 24-months corrected age. Data from this cohort will be used to develop and internally test the toolkit (Aim 2).
Participating children in the Toolkit Validation cohort (Aim 3) will complete biweekly sensor visits from birth to 3 months corrected age (up to 7 visits). In this cohort, the child may continue testing monthly from 4-11 months corrected age ("Surveillance group", up to 8 visits; see below). A follow-up visit will be completed at 12-months corrected age for all participants in the Toolkit Validation cohort. Data from this cohort will be used to validate and refine the toolkit for optimized performance and clinical utility. Children will be assigned to the Surveillance group under this aim, to continue monthly sensor and assessment visits from 4-11 months corrected age, if either of the following occur: (1) The toolkit disagrees with the specialist assessment at 3-months corrected age. (2) If the toolkit identifies the participating child as at risk for motor deficits any time between birth and 3-months corrected age.
For any cohort, the study team will place up to 6 sensors on the child's body and head to observe the participating child's movement. Skin checks will be performed before and after placing the sensors. These visits will take place in participants' home and in the community. There are two components of the sensor visits: Observed Activities and Free-Living Activities. During Observed Activities, the study team will observe the caregiver and participating child during any common daily activities for at least 30 minutes, targeting up to 60 minutes. The study team may ask caregivers to support their child as needed during these activities. During Free-Living Activities, the caregiver will continue to monitor and log their child's activities and behaviors for up to 12 hours. Caregivers will be given a GoPro camera and tripod to record their child's activities inside and outside the home, to their comfort. Caregivers will also be given a manual log to document any activities that the caregivers do not want or are not able to capture on video. The study team will not be present throughout this component. The sensors, log, and GoPro will be picked up the next day or at families earliest convenience
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants 0-3 Months Old at Risk for Motor Delay (Aim 1) | – | – |
| Infants 0-3 Months Old at Risk for Motor Delay Surveillance Group (Aim 3) | – | – |
| Infants 0-3 Months Old at Risk for Motor Delay Non-Surveillance Group (Aim 3) | – | – |
Who may qualify
- Ages
- 0 days to 52 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants who are at risk of motor or other developmental delay
Key inclusion criteria (11 listed)
- The study population comprises infants who are at risk of motor or other developmental delay. "At-risk" is defined as having been admitted to the NICU admission and qualifying for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- BW <1500 grams OR
- Disorders of the central nervous system
- Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
- HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
Key exclusion criteria (11 listed)
- Open wounds, skin condition precluding sensor placement
- Immune deficiencies requiring protective isolation
- Limb reduction defects
- Followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
- Bleeding disorders or ongoing need for anticoagulation
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
3-month Screening Performance (Aims 1-2, Toolkit Development cohort)
Time frame: 3 months
Screening performance of the toolkit at 3 months (internal validation)
3-month Screening Performance (Aim 3; Toolkit Validation cohort)
Time frame: 3 months
Screening performance of the toolkit at 3 months (external validation)
2 secondary outcomes
12-month Screening Performance (Aims 1-2; Toolkit Development cohort)
Time frame: 12 months
12-month Screening Performance (Aim 3; Toolkit Validation cohort)
Time frame: 12 months
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 8 Oct 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.
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 Infant Development, 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month Screening Performance (Aims 1-2, Toolkit Development cohort) (time frame: 3 months). The study lists 2 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 8 Oct 2026.