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NCT Number: NCT06970522

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

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.

Recruiting

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Key information

Age range

0 month–8 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age

    Time frame: Before 8 weeks corrected age

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

Secondary outcomes

  1. Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data

    Time frame: Before 8 weeks corrected age

    Error between true clinical test scores and estimated scores using EMG sensor data, assessed before 8 weeks corrected age.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan O'Brien, PhD

CONTACT

[email protected]

312-238-2289

Rachel Andersen

CONTACT

[email protected]

312-238-1476

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Northwestern University

Registry information

Official study title

Early Detection of Atypical Neuromuscular Development Using Wearable Sensors and Video: A Comparative Analysis of Muscle and Motion

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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