NCT06970522Recruiting
Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
Shirley Ryan AbilityLab
Start Date
6/25/2025
Completion Date
12/31/2026
Summary
The purpose of this study is to see if wearable sensor technology can be used to evaluate muscle activity and/or identify atypical muscle tone in infants up to 48 weeks postmenstrual age (8 weeks corrected age). These sensors are placed on the surface of the skin and record data about a child's body movements and muscle activity.
Eligibility Criteria
Age Range: No minimum to No maximum
Inclusion Criteria:
* For Infants with low tone:
* Hospitalized in the NICU
* AND \>38 weeks post-menstrual age
* AND abnormal normal brain imaging OR Apgar score \<7 at five minutes with umbilical cord pH (if obtained) \<7.15
* AND 2 or more warning signs for muscle tone or posture using the HNNE short form
* AND legal guardian able and willing to give written consent and comply with study procedures
* For Infants with typical tone:
* Born at 38-41 weeks of gestation
* AND hospitalized after birth in the NICU OR well newborn nursery
* AND infants with appropriate for gestational age birth weight
* AND HNNE exam (short proforma) normal with no warning signs for any parameter
* AND legal guardian able and willing to give written consent and comply with study procedures.
Exclusion Criteria:
* Infants of Both Low Tone and Typical Tone Cohorts:
* Missing or incomplete limbs (such as from amputation or congenital limb defects).
* Open wounds or skin breakdown on the limbs or torso.
* Presence of known genetic syndrome or congenital anomalies requiring surgery or affecting function
* Use of sedative medications (may include phenobarbital if level stable and therapeutic)
* Legal guardian unable to give written consent and comply with study procedures.
* Does not receive medical clearance from a physician to participate in the study if the individual is receiving inpatient care.
Conditions
Neuromuscular DisordersMotor DevelopmentMuscle Tone
Locations
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Shirley Ryan AbilityLab
Chicago, Illinois 60611
United States