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Clinical Trials/NCT03067116
NCT03067116
Completed
Not Applicable

Posturography Changes During Pregnancy

Caps Research Network1 site in 1 country4 target enrollmentMay 2016
ConditionsPregnant Women

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnant Women
Sponsor
Caps Research Network
Enrollment
4
Locations
1
Primary Endpoint
Stability Score
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Determine balance changes during pregnancy

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
April 2018
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Caps Research Network
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • healthy women less than 20 weeks pregnant

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Center of Pressure (CoP) coordinates(From enrollment to 6 month post partum)

Study Sites (1)

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