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Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06696495
Acronym
FOOTpreg
Enrollment
100
Registered
2024-11-20
Start date
2025-01-31
Completion date
2027-01-31
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Diseases, Pregnancy Related

Keywords

pregnancy, foot diseases, Postural Balance, Foot Morphology

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.

Interventions

DIAGNOSTIC_TESTMeasurement 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)

Sponsors

University of Seville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ankle and Foot Outcome Score3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancyCompletion 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 Score3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancyCompletion 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 foot3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancyCompletion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026