Posturography Changes During Pregnancy

Study Overview
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Brief Summary
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Determine balance changes during pregnancy

Detailed Description
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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: Subjects will also be asked to answer a short health questionnaire. 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. A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity. 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). 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). 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.

Official Title
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Posturography Changes During Pregnancy

Conditions
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Pregnant Women

Intervention / Treatment
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* Diagnostic Test: Posturography Evaluation
* Diagnostic Test: Anthropometrics
* Diagnostic Test: Vitals
* Other: Health and daily activity questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy women less than 20 weeks pregnant Exclusion Criteria: women affected by any pathology and/or more than 20 weeks pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects<br>Adult, healthy pregnant women undergoing Posturography Evaluation, Anthropometrics, Vitals and answering Health and daily activity questionnaires | Diagnostic Test: Posturography Evaluation<br>* Posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, with eyes open or closed<br>* Other names: CAPS® Testing;Diagnostic Test: Anthropometrics<br>* measurement of height, minimum stance width (feet together or as close as they can be), circumference of the torso at the breast level, of the abdomen, of the hip, and of each thigh, and supine fundal height<br>Diagnostic Test: Vitals<br>* measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability<br>Other: Health and daily activity questionnaires<br>* one time general health questionnaire as well as session questionnaires asking the subjects if they have fallen since their last testing session and how comfortable they are in doing daily activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability Score | The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires | From enrollment to 6 month post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center of Pressure (CoP) coordinates | The CoP coordinates (standard posturography measurements) will be also used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires | From enrollment to 6 month post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, postural, fall risk, anthropometrics, blood pressure, SpO2, heart rate, heart rate variability, stance width