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Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Recruiting
8 years and younger
All
Phase N/A

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Overview

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

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.

Study details
    Neuromuscular Disorders
    Motor Development
    Muscle Tone

NCT06970522

Shirley Ryan AbilityLab

15 October 2025

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