Posturography Changes During Pregnancy

Completed

• Conditions: Pregnant Women
• Interventions: Diagnostic Test: Posturography Evaluation; Diagnostic Test: Anthropometrics; Diagnostic Test: Vitals; Other: Health and daily activity questionnaires

• Registration Number: NCT03067116
• Lead Sponsor: Caps Research Network

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Primary Completion: 2017-04
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• healthy women less than 20 weeks pregnant

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Stability Score	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 Outcome Measures

Name	Time	Method
Center of Pressure (CoP) coordinates	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

Trial Locations

Locations (1)

Innova Brain Rehabilitation; 🇺🇸 Marietta, Georgia, United States