Status:
RECRUITING
Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Ann & Robert H Lurie Children's Hospital of Chicago
Northwestern University
Conditions:
Neuromuscular Disorders
Motor Development
Eligibility:
All Genders
Up to 8 years
Brief 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 corr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06970522
Start Date
June 25 2025
End Date
May 31 2026
Last Update
July 30 2025
Active Locations (2)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611