| Registry | NCT03067116 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 4 (Actual) |
| Sponsor | Caps Research Network (Other) |
| Conditions | Pregnant Women |
| Interventions | Posturography Evaluation, Anthropometrics, Vitals, Health and daily activity questionnaires (Diagnostic test, other) |
| Dates | start 2016-05-01, primary completion 2017-04-01, completion 2018-04-01, first posted 2017-03-01, last updated 2026-10-23 |
| Locations | 1 site in United States |
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Determine balance changes during pregnancy
The subjects will be tested at enrollment and during weeks 20, 24, 28, 32, 36, 40 of their pregnancy, as well every 4 weeks postpartum up to 6 months. The following protocol will be used:
1. Subjects will also be asked to answer a short health questionnaire.
2. The following data will be recorded each time: height, minimum stance width, circumference measurements of the chest, abdomen, hip and each thigh as well as a supine fundal height. A full body side-profile photo was also taken to determine the curvature of the spine.
3. A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity.
4. In a seated position, the following measurements will be recorded: 1-minute heart rate variability (HRV) with paced breathing, temporal scan body temperature, respiration rate, heart rate, blood pressure and SpO2 (these last three will be measured bilaterally).
5. Subject will undergo posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: four 30 s tests in the following conditions: eyes open on a rigid surface (NSEO), eyes closed on a rigid surface (NSEC), eyes open on a compliant surface (PSEO), and eyes closed on a compliant surface (PSEC).
6. At the end of the posturography testing, heart rate, blood pressure and SpO2 will be re-measured bilaterally in the standing and then seated positions, as will be the seated HRV.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Subjects | Diagnostic Test: Posturography Evaluation; Diagnostic Test: Anthropometrics; Diagnostic Test: Vitals; Other: Health and daily activity questionnaires | Adult, healthy pregnant women undergoing Posturography Evaluation, Anthropometrics, Vitals and answering Health and daily activity questionnaires |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * healthy women less than 20 weeks pregnant Exclusion Criteria: * women affected by any pathology and/or more than 20 weeks pregnant
| Facility | City | Country | Status |
|---|---|---|---|
| Innova Brain Rehabilitation | Marietta, Georgia | United States |