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
1 other identifier
observational
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 25, 2026
March 1, 2026
1.5 years
May 6, 2025
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation Between EMG Data and Observed Muscle Tone 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.
Before 8 weeks corrected age
Secondary Outcomes (1)
Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data
Before 8 weeks corrected age
Study Arms (2)
Infants with Typical Tone
Infants with Low Tone
Eligibility Criteria
Infants presenting with atypical muscle tone based on clinical expertise along with infants expected to have typical development.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirley Ryan AbilityLablead
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- Northwestern Universitycollaborator
Study Sites (2)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arun Jayaraman, PT, PhD
Shirley Ryan AbilityLab
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
June 25, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 25, 2026
Record last verified: 2026-03