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Wearable Sensors for Atypical Muscle Activation in Infants

This study is looking at whether wearable sensors can help detect unusual muscle activity or tone in young infants. These sensors are placed on the baby's skin to record movements and muscle activity. The study aims to see how well the information from these sensors matches what doctors observe about a baby's muscle tone before they reach 8 weeks corrected age (meaning, 8 weeks from their original due date). You might be able to join if your baby is between 0 and 8 weeks old and has low muscle tone. This includes babies in the NICU who are at least 38 weeks post-menstrual age (meaning, 38 weeks from the first day of their last period) and have certain brain imaging results or Apgar scores. The study is currently unclear about its recruitment status.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 40 infants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement is taken before 8 weeks corrected age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06970522

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Recruiting
Not specifiedAges 0–8Observational
Shirley Ryan AbilityLab
~40 participants
Updated 2026-03-25 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age
Measured over Before 8 weeks corrected age

Conditions

Neuromuscular Disorders
Motor Development
Muscle Tone

Explore related trials

Neuromuscular Disorder

Where it's being run

2 sites across 1 states
Illinois2

Study leadership

  • Arun Jayaraman, PT, PhD · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab

Who to contact

Rachel Andersen
[email protected]
312-238-1476
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected AgeBefore 8 weeks corrected age

    Correlation of EMG sensor data and Hammersmith Neonatal Neurological Exam (HNNE) short form score, assessed before 8 weeks corrected age.