Posturography Changes During Pregnancy

Pregnant Women Clinical Trial

Official title:

Posturography Changes During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067116
• Other study ID #: CI-IRB-20160524-01
• Status: Completed
• First received: February 17, 2017
• Last updated: April 23, 2018
• Start date: May 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Caps Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determine balance changes during pregnancy

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy women less than 20 weeks pregnant

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

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

Other:
• 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

Locations

Country	Name	City	State
United States	Innova Brain Rehabilitation	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Caps Research Network

Country where clinical trial is conducted

United States, 

References & Publications (1)

C.C. Keiser, N.D. Keiser, G. Pagnacco, E. Oggero "REPEATED EVALUATIONS OF FALL RISK AND POSTUROGRAPHIC CHANGES DURING PREGNANCY AND POST-PARTUM: A FEASIBILITY STUDY", Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 269-75.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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