Actively Recruiting

Age: 0Months - 8Weeks
All Genders
NCT06970522

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Led by Shirley Ryan AbilityLab · Updated on 2026-03-25

40

Participants Needed

2

Research Sites

79 weeks

Total Duration

On this page

Sponsors

S

Shirley Ryan AbilityLab

Lead Sponsor

A

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Who Can Participate

Age: 0Months - 8Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For infants with low tone:
  • Hospitalized in the NICU
  • More than 38 weeks post-menstrual age
  • Abnormal brain imaging or Apgar score less than 7 at five minutes with umbilical cord pH less than 7.15 (if obtained)
  • Two or more warning signs for muscle tone or posture using the HNNE short form
  • Legal guardian able and willing to give written consent and comply with study procedures
  • For infants with typical tone:
  • Born at 38 to 41 weeks of gestation
  • Hospitalized after birth in the NICU or well newborn nursery
  • Appropriate for gestational age birth weight
  • Normal HNNE exam (short proforma) with no warning signs for any parameter
  • Legal guardian able and willing to give written consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • 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 if receiving inpatient care

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

2

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

R

Rachel Andersen

CONTACT

M

Megan O'Brien, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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