Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06970522

Enrollment

Registered

2025-05-14

Start date

2025-06-25

Completion date

2026-12-31

Last updated

2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Development, Muscle Tone, Neuromuscular Disorders

Keywords

Early Detection, Wearable Sensors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

0 Months to 8 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTRachel Andersen

randersen@sralab.org312-238-1476

CONTACTMegan O'Brien, PhD

mobrien02@sralab.org312-238-2289

PRINCIPAL_INVESTIGATORArun Jayaraman, PT, PhD

Shirley Ryan AbilityLab

Outcome results