Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Recruiting

• Conditions: Neuromuscular Disorders; Motor Development; Muscle Tone

• Registration Number: NCT06970522
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Study Start: 2025-05-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age	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 Outcome Measures

Name	Time	Method
Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data	Before 8 weeks corrected age	Error between true clinical test scores and estimated scores using EMG sensor data, assessed before 8 weeks corrected age.

Trial Locations

Locations (2)

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

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States