Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women

NCT06696495 | Not Yet Recruiting

• 1 other identifier: FOOTPREGNANT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy Related; Foot Diseases

Keywords

pregnancy; foot diseases; Postural Balance; Foot Morphology

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Measurement of the size and width of the foot DIAGNOSTIC_TEST

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)

Pregnancy women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: The objective is to know the morphofunctional changes of the foot during pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (2)

Clinica Rayo

Seville, SEVILLA, 41008, Spain

Location

Universidad de Sevilla

Seville, Sevilla, 41009, Spain

Location

MeSH Terms

Conditions

Foot Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)