Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women

Официальное название

Evaluation of Morphofunctional and Baropodometric Changes in the Foot and Ankle of Pregnant Women: Longitudinal Study from the Pregestational Stage to the Postpartum Period

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Measurement of the size and width of the foot
  Assessment of the height of the plantar arch using a podoscope, and application of functional scales such as the AOFAS (Ankle and Foot Outcome Score), the FPI (Foot Posture Index) and the FFI (Foot Function Index). In addition, the distribution of plantar pressure and the centre of pressure (COP)

Первичные конечные точки

• Ankle and Foot Outcome Score [Срок оценки: 3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy]
• Foot Fuction Index Score [Срок оценки: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy]
• Measurement of the length and width of the foot [Срок оценки: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 2 центра

• Clinica Rayo — Seville
• Universidad de Sevilla — Seville

Идентификаторы

NCT: NCT06696495 · FOOTPREGNANT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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