Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06970522

Conditions

Neuromuscular Disorders

Motor Development

Muscle Tone

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Neuromuscular Disorders

Motor Development

Muscle Tone

Study ID

NCT06970522

Start date

Jun 25, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants with Typical Tone

Infants with Low Tone

Primary outcome measure

  • Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age [ Time Frame: Before 8 weeks corrected age ]

Central Contacts and Locations

Central contacts

Rachel Andersen

312-238-1476randersen@sralab.org

Megan O'Brien, PhD

312-238-2289mobrien02@sralab.org

Locations

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

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Raye-Ann Odegaard deRegnier, MD

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Arun Jayaraman, PT, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • Early Detection
  • Wearable Sensors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-03-25.