Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of the size and width of the foot.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Foot Diseases. Basic parameters: 20 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Morphofunctional and Baropodometric Changes in the Foot and Ankle of Pregnant Women: Longitudinal Study from the Pregestational Stage to the Postpartum Period
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test 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)
Primary outcome measures
- Ankle and Foot Outcome Score [Time frame: 3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy]
- Foot Fuction Index Score [Time frame: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy]
- Measurement of the length and width of the foot [Time frame: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Clinica Rayo — Seville
- Universidad de Sevilla — Seville
Identifiers
NCT: NCT06696495 · FOOTPREGNANT