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Tiny sensors, big hope: detecting baby muscle issues before they worsen

NCT ID NCT06970522

Knowledge-focused Sponsor: Shirley Ryan AbilityLab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study explores whether small, skin-friendly sensors can detect early signs of muscle tone problems in newborns up to 8 weeks old. Researchers will compare sensor data with standard medical exams to see if the technology can identify atypical muscle development sooner. The goal is to improve early diagnosis of neuromuscular disorders in infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

0 months to 8 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neuromuscular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Motor development Muscle tone Neuromuscular disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Shirley Ryan AbilityLab

    RECRUITING

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.