Clinical trial NCT06970522: Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
Official title: Early Detection of Atypical Neuromuscular Development Using Wearable Sensors and Video: A Comparative Analysis of Muscle and Motion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Disorders
Motor Development
Muscle Tone
Keywords: Early Detection
Wearable Sensors
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Northwestern University
First posted: 2025-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants presenting with atypical muscle tone based on clinical expertise along with infants expected to have typical development.

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 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: 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.

Primary outcomes:
measure: Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age
timeFrame: Before 8 weeks corrected age
Secondary outcomes:
measure: Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data
timeFrame: Before 8 weeks corrected age
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: