Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

ConditionsNeuromuscular Disorders Motor Development Muscle Tone

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-8

SponsorShirley Ryan AbilityLab

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

40 Participants

are grouped into 2 trial groups

Group A: Infants with Typical Tone

Group B: Infants with Low Tone

Trial outcomes

Primary outcomes

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.

Time frame

Before 8 weeks corrected age

Secondary outcomes

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.

Time frame

Before 8 weeks corrected age

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Northwestern University