Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women (FOOTpreg)

University of Seville

Status: Begins enrollment this month

Conditions: Foot Diseases; Pregnancy Related

Treatments: Diagnostic Test: Measurement of the size and width of the foot

Study type: Observational

Funder types: Other

Identifiers

NCT06696495

FOOTPREGNANT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy women between 20 and 35 years old.
2. If pregnant, they must be in the first trimester of pregnancy (before week 12).
3. Absence of chronic or acute pathologies that may interfere with the analysis of biomechanical variables (arthritis, vascular or metabolic problems).
4. Not having had previous foot or ankle surgeries.

Exclusion criteria

1. Women with multiple pregnancies (twin or multiple pregnancies increase biomechanical variations).
2. Conditions that affect gait or foot structure (arthritis, neuropathies, or other orthopedic problems).
3. History of previous foot or ankle injuries that may alter measurements.

Trial design

100 participants in 1 patient group

Pregnancy women

Description:

Each participant will undergo various tests to assess morphofunctional and baropodometric changes in the foot and ankle. These tests will include measuring the size and width of the foot using a 3D scanner, assessing the height of the plantar arch using a podoscope, and applying functional scales such as the AOFAS (Ankle and Foot Outcome Score), the FPI (Foot Posture Index) and the FFI (Foot Function Index). In addition, plantar pressure distribution and centre of pressure (COP) will be analysed to identify variations in stability and balance during pregnancy.

Treatment:

Diagnostic Test: Measurement of the size and width of the foot