Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-35
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measurement of the size and width of the foot
Diagnostic testAssessment 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)
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Pregnancy women1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy2
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.
Time frame
3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy3
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
Time frame
3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: