Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
March 21, 2025 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
The feet, which are support surfaces, are adapted to the physiological relaxation and biomechanical changes that occur during pregnancy.
In this adaptation, it has not been objectively clarified how the plantar fascia, which plays a very important role in maintaining the height of the plantar arch, undergoes a change.
Therefore, the aim of this pilot study is to investigate the normative values of trimester-specific biomechanical and viscoelastic properties of the plantar fascia, which adapts to changes in foot structure during pregnancy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
172
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey
- Istanbul Medeniyet University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 36 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Pregnant women in the first- trimester, second trimester or third trimester (first-time pregnancy)
Description
Inclusion Criteria:
- First-time pregnancy
- They are between the ages of 18-40
- Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2
Exclusion Criteria:
- Presence of any connective tissue disease that would affect the biomechanical or viscoelastic properties of the fascia
- Deterioration of skin integrity in measurement areas
- Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment
- History of surgery or fracture in the lower extremity and foot-ankle region in the last 6 months
- Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
First trimester pregnant women (first pregnancy)
This group will consist of women in the first trimester and in first trimester of pregnancy
|
The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position. Measurements will be made with the ankle in neutral position.
Foot length and width will be measured.
The amount of navicular drop of both feet will be measured.
Foot posture will be evaluated according to Foot Posture Index.
|
|
Second trimester pregnant women (first pregnancy)
This group will consist of women in the second trimester and in first trimester of pregnancy
|
The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position. Measurements will be made with the ankle in neutral position.
Foot length and width will be measured.
The amount of navicular drop of both feet will be measured.
Foot posture will be evaluated according to Foot Posture Index.
|
|
Third trimester pregnant women (first pregnancy)
This group will consist of women in the third trimester and in first trimester of pregnancy
|
The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position. Measurements will be made with the ankle in neutral position.
Foot length and width will be measured.
The amount of navicular drop of both feet will be measured.
Foot posture will be evaluated according to Foot Posture Index.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of biomechanical properties of plantar fascia
Time Frame: The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
|
Measuring of the stiffness (N/m) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
|
The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
|
|
Evaluation of biomechanical properties of plantar fascia
Time Frame: The measurement of the baseline decrement values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Measuring of the decrement of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
|
The measurement of the baseline decrement values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of biomechanical properties of plantar fascia
Time Frame: The measurement of the baseline tone values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Measuring of the tone (Hz) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
|
The measurement of the baseline tone values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of viscoelastic properties of plantar fascia
Time Frame: The measurement of the baseline creep values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Measuring of the creep of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
|
The measurement of the baseline creep values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of viscoelastic properties of plantar fascia
Time Frame: The measurement of the baseline relaxation time values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Measuring of the relaxation time (ms) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
|
The measurement of the baseline relaxation time values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Body Weight
Time Frame: The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Body weight (kg) will be measured
|
The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of Body Mass Index (BMI)
Time Frame: The measurement of the baseline BMI between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
BMI will be calculated as person's weight in kilograms divided by the square of height in meters
|
The measurement of the baseline BMI between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of Foot Morphological Characteristics
Time Frame: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Foot width (cm) will be measured
|
The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of Foot Morphological Characteristics
Time Frame: The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Foot length (cm) will be measured
|
The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of foot mobility
Time Frame: The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Navicular drop values will be measured
|
The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
|
Evaluation of foot posture
Time Frame: The measurement of the baseline foot posture characteristics between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Foot posture will be evaluated according to foot posture index.
|
The measurement of the baseline foot posture characteristics between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Challis JR, Lockwood CJ, Myatt L, Norman JE, Strauss JF 3rd, Petraglia F. Inflammation and pregnancy. Reprod Sci. 2009 Feb;16(2):206-15. doi: 10.1177/1933719108329095.
- Cherni Y, Desseauve D, Decatoire A, Veit-Rubinc N, Begon M, Pierre F, Fradet L. Evaluation of ligament laxity during pregnancy. J Gynecol Obstet Hum Reprod. 2019 May;48(5):351-357. doi: 10.1016/j.jogoh.2019.02.009. Epub 2019 Feb 20.
- Segal NA, Boyer ER, Teran-Yengle P, Glass NA, Hillstrom HJ, Yack HJ. Pregnancy leads to lasting changes in foot structure. Am J Phys Med Rehabil. 2013 Mar;92(3):232-40. doi: 10.1097/PHM.0b013e31827443a9.
- Huang J, Qin K, Tang C, Zhu Y, Klein CS, Zhang Z, Liu C. Assessment of Passive Stiffness of Medial and Lateral Heads of Gastrocnemius Muscle, Achilles Tendon, and Plantar Fascia at Different Ankle and Knee Positions Using the MyotonPRO. Med Sci Monit. 2018 Oct 23;24:7570-7576. doi: 10.12659/MSM.909550.
- Sanjana F, Chaudhry H, Findley T. Effect of MELT method on thoracolumbar connective tissue: The full study. J Bodyw Mov Ther. 2017 Jan;21(1):179-185. doi: 10.1016/j.jbmt.2016.05.010. Epub 2016 Jun 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
March 12, 2022
First Submitted That Met QC Criteria
March 31, 2022
First Posted (Actual)
April 8, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 21, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.