Wearable Sensor Toolkit for Infant Motor Development

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-52
SponsorShirley Ryan AbilityLab

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

infants who are at risk of motor or other developmental delay

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Infants 0-3 Months Old at Risk for Motor Delay (Aim 1)
Group B: Infants 0-3 Months Old at Risk for Motor Delay Surveillance Group (Aim 3)
Group C: Infants 0-3 Months Old at Risk for Motor Delay Non-Surveillance Group (Aim 3)

Trial outcomes

Primary outcomes

1

3-month Screening Performance (Aims 1-2, Toolkit Development cohort)

Screening performance of the toolkit at 3 months (internal validation)

Time frame
3 months
2

3-month Screening Performance (Aim 3; Toolkit Validation cohort)

Screening performance of the toolkit at 3 months (external validation)

Time frame
3 months

Secondary outcomes

1

12-month Screening Performance (Aims 1-2; Toolkit Development cohort)

Screening performance of the toolkit at 12 months (internal validation)

Time frame
12 months
2

12-month Screening Performance (Aim 3; Toolkit Validation cohort)

Screening performance of the toolkit at 12 months (external validation)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

University of Illinois at Chicago

Collaborator

This trial is not recruiting at the moment. You can still explore other options: