Wearable Sensors to Detect Atypical Muscle Activation in Young Infants
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 muscl
| Condition(s) | Neuromuscular Disorders, Motor Development, Muscle Tone |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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: |
| Ages | 0 Months to 8 Weeks |
| Sex | All |
| Lead sponsor | Shirley Ryan AbilityLab |
| Locations | Chicago, Illinois, United States; Chicago, Illinois, United States |
| Start date | 2025-06-25 |
| NCT ID | NCT06970522 |
| Official listing | https://clinicaltrials.gov/study/NCT06970522 |