Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
Recruiting now
Conditions studied: Neuromuscular Disorders, Motor Development, Muscle Tone
In brief
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.
Key facts
- Study ID
- NCT06970522
- Run by
- Shirley Ryan AbilityLab
- People needed
- 40
- Starts
- 2025-06-25
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-25
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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