Posturography Changes During Pregnancy
1 other identifier
observational
4
1 country
1
Brief Summary
Determine balance changes during pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 25, 2018
April 1, 2018
11 months
February 17, 2017
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Center of Pressure (CoP) coordinates
From enrollment to 6 month post partum
Study Arms (1)
Subjects
Adult, healthy pregnant women undergoing Posturography Evaluation, Anthropometrics, Vitals and answering Health and daily activity questionnaires
Interventions
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
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
measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability
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
Eligibility Criteria
Adult, healthy pregnant women
You may qualify if:
- healthy women less than 20 weeks pregnant
You may not qualify if:
- women affected by any pathology and/or more than 20 weeks pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Innova Brain Rehabilitation
Marietta, Georgia, 30062, United States
Related 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.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Oggero, PhD
Caps Research Network
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
March 1, 2017
Study Start
May 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2018
Last Updated
April 25, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share