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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Foot Diseases; Pregnancy Related
• Intervention / Treatment: Diagnostic test: Measurement of the size and width of the foot

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41008
    • Clinica Rayo
  • Sevilla, Spain, 41009
    • Universidad de Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of healthy women between 20 and 35 years of age who meet the established inclusion criteria. If the participants are pregnant, they must be in the first trimester of pregnancy, that is, before week 12. It will be ensured that they do not have chronic or acute pathologies, such as arthritis or vascular or metabolic problems, that could interfere with the analysis of the biomechanical variables. In addition, the participants must not have had previous surgeries on the foot or ankle. On the other hand, women with multiple pregnancies will be excluded from the study, as well as those who suffer from conditions that affect the gait or the structure of the foot, and those who have a history of previous injuries to the foot or ankle that could alter the measurements.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pregnancy women; 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.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle and Foot Outcome Score	Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy. The score is 0 to 100 points.	3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
Foot Fuction Index Score	Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy. The score is 0 to 100 points.	3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
Measurement of the length and width of the foot	Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy	3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pregnancy; Postural Balance; foot diseases; Foot Morphology
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Skin Diseases; Foot Diseases
• Other Study ID Numbers: FOOTPREGNANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No