Evaluation of Morphofunctional and Baropodometric Changes in the Foot and Ankle of Pregnant Women: Longitudinal Study from the Pregestational Stage to the Postpartum Period
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ankle and Foot Outcome Score
研究概览
简要总结
Pregnancy causes physiological and biomechanical changes in the female body, such as weight gain and hormonal changes, which can affect the structure and function of the foot and ankle. These adaptations can influence gait, balance and stability. However, the temporal evolution of these changes in the foot and ankle before, during and after pregnancy is not well documented. This study aims to characterize and quantify these changes, as well as their impact on foot function, with the aim of contributing to the prevention and management of podiatric and orthopedic problems in pregnant women.
详细描述
Pregnancy causes physiological and biomechanical changes in the female body, such as weight gain and hormonal changes, which can affect the structure and function of the foot and ankle. These adaptations can influence gait, balance and stability. However, the temporal evolution of these changes in the foot and ankle before, during and after pregnancy is not well documented. This study aims to characterize and quantify these changes, as well as evaluate their impact on foot function, thus contributing to the prevention and management of podiatric and orthopedic problems in pregnant women.
The general objective of this study is to evaluate the morphofunctional and baropodometric changes of the foot and ankle in pregnant women from the pre-gestational period to the postpartum period. Specific objectives include determining changes in foot and ankle size and width at different stages, assessing foot function using the AOFAS (Ankle and Foot Outcome Score), FPI (Foot Posture Index) and FFI (Foot Function Index) indices, analyzing plantar pressure distribution and baropodometric changes, and correlating morphofunctional and baropodometric changes with weeks of gestation and maternal weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women between 20 and 35 years old.
- •If pregnant, they must be in the first trimester of pregnancy (before week 12).
- •Absence of chronic or acute pathologies that may interfere with the analysis of biomechanical variables (arthritis, vascular or metabolic problems).
- •Not having had previous foot or ankle surgeries.
排除标准
- •Women with multiple pregnancies (twin or multiple pregnancies increase biomechanical variations).
- •Conditions that affect gait or foot structure (arthritis, neuropathies, or other orthopedic problems).
- •History of previous foot or ankle injuries that may alter measurements.
结局指标
主要结局
Ankle and Foot Outcome Score
时间窗: 3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy. The score is 0 to 100 points.
Foot Fuction Index Score
时间窗: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy. The score is 0 to 100 points.
Measurement of the length and width of the foot
时间窗: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
次要结局
未报告次要终点
研究者
ANA MARIA RAYO PEREZ
Principal Investigator
University of Seville