Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Muscle Tone; Neuromuscular Disorders; Motor Development

Study type: Observational

Funder types: Other

Identifiers

NCT06970522

2024 6737

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 8 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Infants with Typical Tone

Infants with Low Tone