Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women

Not yet recruiting

• Conditions: Pregnancy Related; Foot Diseases

• Registration Number: NCT06696495
• Lead Sponsor: University of Seville

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-10-31
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-17
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankle and Foot Outcome Score	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	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	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

Trial Locations

Locations (2)

Clinica Rayo; 🇪🇸 Sevilla, Spain

Universidad de Sevilla; 🇪🇸 Sevilla, Spain