Neuromuscular DisordersNCT06970522
Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
An observational study of Neuromuscular Disorders and Motor Development, run by Shirley Ryan AbilityLab at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 months to 8 weeks
- Conditions the study is for
- Neuromuscular Disorders, Motor Development, Muscle Tone
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 8 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants presenting with atypical muscle tone based on clinical expertise along with infants expected to have typical development.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Raye-Ann Odegaard deRegnier, MD
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Arun Jayaraman, PT, PhD
About this study
Official title: Early Detection of Atypical Neuromuscular Development Using Wearable Sensors and Video: A Comparative Analysis of Muscle and Motion
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
- Keywords
- Early Detection, Wearable Sensors
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants with Typical Tone | Not described | |
| Infants with Low Tone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before 8 weeks corrected age
Secondary outcomes (1)
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.
Measured: Before 8 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start25 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DisordersStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970522
- Sponsor's protocol ID
- 2024 6737
- Status last verified
- Mar 2026
- First submitted
- 6 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Atypical Neuromuscular Development Using Wearable Sensors and Video: A Comparative Analysis of Muscle and Motion
- ClinicalTrials.gov ID
- NCT06970522
- Acronym / sponsor ID
- 2024 6737
- Conditions
- Neuromuscular Disorders, Motor Development, Muscle Tone
- Keywords
- Early Detection, Wearable Sensors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with Typical Tone | – | – |
| Infants with Low Tone | – | – |
Who may qualify
- Ages
- 0 months to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants presenting with atypical muscle tone based on clinical expertise along with infants expected to have typical development.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age
Time frame: 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.
1 secondary outcome
Estimation of Clinical Scores Performed Before 8 Weeks Corrected Age Using EMG Data
Time frame: Before 8 weeks corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Disorders and Motor Development, run by Shirley Ryan AbilityLab at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Andersen (312-238-1476, randersen@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between EMG Data and Observed Muscle Tone Before 8 Weeks Corrected Age (time frame: Before 8 weeks corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.