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OpenTrials
Completed

NCT Number: NCT03067116

Posturography Changes During Pregnancy

Determine balance changes during pregnancy

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Innova Brain Rehabilitation

Marietta, Georgia, 30062, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy women less than 20 weeks pregnant

Exclusion criteria

  • women affected by any pathology and/or more than 20 weeks pregnant

Treatment and study plan

Posturography Evaluation

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

Other names: Balance Testing, CAPS® Testing

Anthropometrics

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

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

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

Primary outcomes

  1. Stability Score

    Time frame: From enrollment to 6 month post partum

    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

Secondary outcomes

  1. Center of Pressure (CoP) coordinates

    Time frame: From enrollment to 6 month post partum

    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

Sponsors and collaborators

Lead sponsor

Caps Research Network

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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