Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neuromuscular Disorders, Motor Development, Muscle Tone. Basic parameters: 0 months — 8 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Detection of Atypical Neuromuscular Development Using Wearable Sensors and Video: A Comparative Analysis of Muscle and Motion
Overview
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.
Primary outcome measures
- Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age [Time frame: Before 8 weeks corrected age]
Secondary outcome measures (1)
- Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data [Time frame: Before 8 weeks corrected age]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
- Shirley Ryan AbilityLab — Chicago
Identifiers
NCT: NCT06970522 · 2024 6737