Using wearable sensors to monitor muscle activity in infants

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

This study is testing if wearable sensors can help track muscle activity in infants to spot any unusual muscle tone early on.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 0 Months to 8 Weeks
• Sex: All
• Sponsor: Shirley Ryan AbilityLab (other)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT06970522 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of wearable sensor technology in assessing muscle activity and identifying atypical muscle tone in infants up to 48 weeks postmenstrual age. The sensors are placed on the skin to record data on body movements and muscle activity, focusing on infants with both low and typical muscle tone. The study includes infants hospitalized in the NICU or well newborn nursery, and it seeks to gather data that could lead to early detection of neuromuscular disorders.

Who should consider this trial

Good fit: Ideal candidates include infants with low muscle tone hospitalized in the NICU or those with typical muscle tone born at 38-41 weeks of gestation.

Not a fit: Patients with missing or incomplete limbs, open wounds, or skin breakdown on the limbs or torso may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable early detection of neuromuscular disorders in infants, leading to timely interventions.

How similar studies have performed: While the use of wearable sensors for muscle activity monitoring is a growing field, this specific application in infants is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Chicago, Illinois and 1 other locations

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (RECRUITING)
• Shirley Ryan AbilityLab — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
• Study coordinator: Rachel Andersen

Conditions: Neuromuscular Disorders, Motor Development, Muscle Tone, Early Detection, Wearable Sensors