Posturography Changes During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-04-30

Brief Summary

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Determine balance changes during pregnancy

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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:

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.

Conditions

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Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects

Adult, healthy pregnant women undergoing Posturography Evaluation, Anthropometrics, Vitals and answering Health and daily activity questionnaires

Posturography Evaluation

Intervention Type DIAGNOSTIC_TEST

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

Anthropometrics

Intervention Type DIAGNOSTIC_TEST

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

Vitals

Intervention Type DIAGNOSTIC_TEST

measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability

Health and daily activity questionnaires

Intervention Type OTHER

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

Interventions

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Posturography Evaluation

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

Intervention Type DIAGNOSTIC_TEST

Anthropometrics

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

Intervention Type DIAGNOSTIC_TEST

Vitals

measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability

Intervention Type DIAGNOSTIC_TEST

Health and daily activity questionnaires

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

Intervention Type OTHER