An observational study in Motor Delay, Infant Development and Motor Development of Premature Infants, sponsored by Shirley Ryan AbilityLab. Not yet recruiting at 2 sites in United States. Open to participants aged 0 Days to 52 Weeks. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Shirley Ryan AbilityLab · Observational
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.
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
21 studies on the registry are indexed under Psychomotor Disorders; 7 are open to participants now.
Browse Psychomotor Disorders studies →Shirley Ryan AbilityLab is the lead sponsor of 178 studies on the registry; 44 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
infants who are at risk of motor or other developmental delay
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:
AND
- Medically stable (as determined by their neonatologist) AND able to begin study procedures between 34-48 weeks PMA.
Exclusion Criteria:
3-month Screening Performance (Aims 1-2, Toolkit Development cohort)
Screening performance of the toolkit at 3 months (internal validation)
Time frame: 3 months
3-month Screening Performance (Aim 3; Toolkit Validation cohort)
Screening performance of the toolkit at 3 months (external validation)
Time frame: 3 months
12-month Screening Performance (Aims 1-2; Toolkit Development cohort)
Screening performance of the toolkit at 12 months (internal validation)
Time frame: 12 months
12-month Screening Performance (Aim 3; Toolkit Validation cohort)
Screening performance of the toolkit at 12 months (external validation)
Time frame: 12 months
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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