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临床试验/NCT03067116
NCT03067116
已完成
不适用

Posturography Changes During Pregnancy

Caps Research Network1 个研究点 分布在 1 个国家目标入组 4 人2016年5月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Pregnant Women
发起方
Caps Research Network
入组人数
4
试验地点
1
主要终点
Stability Score
状态
已完成
最后更新
8年前

概览

简要总结

Determine balance changes during pregnancy

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2016年5月
结束日期
2018年4月
最后更新
8年前
研究类型
Observational
性别
Female

研究者

发起方
Caps Research Network
责任方
Sponsor

入排标准

入选标准

  • healthy women less than 20 weeks pregnant

排除标准

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

结局指标

主要结局

Stability Score

时间窗: 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

次要结局

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

研究点 (1)

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