Wearable Sensors to Detect Atypical Muscle Activation in... | NCT06970522

Studies
Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

NCT06970522

Sponsor

Shirley Ryan AbilityLab

Status

Recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Neuromuscular Disorders
Motor Development
Muscle Tone

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

May 6, 2025

First Submission Date that Met QC Criteria

May 6, 2025

First Posted Date

May 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 25, 2026Actual

Name	Class
Ann & Robert H Lurie Children's Hospital of Chicago	OTHER
Northwestern University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data	Error between true clinical test scores and estimated scores using EMG sensor data, assessed before 8 weeks corrected age.	Before 8 weeks corrected age

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

8 Weeks

Standard Ages

Child

Study Population

Infants presenting with atypical muscle tone based on clinical expertise along with infants expected to have typical development.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rachel Andersen	Contact	312-238-1476		randersen@sralab.org
Megan O'Brien, PhD	Contact	312-238-2289		mobrien02@sralab.org

Overall Officials

Name	Affiliation	Role
Arun Jayaraman, PT, PhD	Shirley Ryan AbilityLab	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ann & Robert H. Lurie Children's Hospital of Chicago	Recruiting	Chicago	Illinois	60611	United States

Label	Type	Description	Intervention Names
Infants with Typical Tone
Infants with Low Tone