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CompletedNCT05318001Updated Mar 24, 2025

Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study

An observational study in Pregnant Women, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
172
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pregnant Women

Keywords

  • stiffness
  • creep
  • normative data
  • plantar fascia
  • pregnant women
03

In context

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnant women in the first- trimester, second trimester or third trimester (first-time pregnancy)

Inclusion criteria

  • First-time pregnancy
  • They are between the ages of 18-40
  • Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
172 participants (actual)
Patient registry
No

Groups and cohorts

  • First trimester pregnant women (first pregnancy)

    This group will consist of women in the first trimester and in first trimester of pregnancy

    Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia · Other: Evaluation of Foot Morphological Characteristics · Other: Evaluation of navıcular mobility · Other: Evaluation of Foot Posture

  • Second trimester pregnant women (first pregnancy)

    This group will consist of women in the second trimester and in first trimester of pregnancy

    Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia · Other: Evaluation of Foot Morphological Characteristics · Other: Evaluation of navıcular mobility · Other: Evaluation of Foot Posture

  • Third trimester pregnant women (first pregnancy)

    This group will consist of women in the third trimester and in first trimester of pregnancy

    Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia · Other: Evaluation of Foot Morphological Characteristics · Other: Evaluation of navıcular mobility · Other: Evaluation of Foot Posture

Interventions

  • OtherEvaluation of biomechanics and viscoelastic properties of plantar fascia

    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.

  • OtherEvaluation of Foot Morphological Characteristics

    Foot length and width will be measured.

  • OtherEvaluation of navıcular mobility

    The amount of navicular drop of both feet will be measured.

  • OtherEvaluation of Foot Posture

    Foot posture will be evaluated according to Foot Posture Index.

06

What researchers measure

Primary outcomes

  1. Evaluation of biomechanical properties of plantar fascia

    Measuring of the stiffness (N/m) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.

    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.

  2. Evaluation of biomechanical properties of plantar fascia

    Measuring of the decrement of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.

    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

  3. Evaluation of biomechanical properties of plantar fascia

    Measuring of the tone (Hz) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.

    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

  4. Evaluation of viscoelastic properties of plantar fascia

    Measuring of the creep of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.

    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

  5. Evaluation of viscoelastic properties of plantar fascia

    Measuring of the relaxation time (ms) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.

    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

Secondary outcomes

  1. Evaluation of Body Weight

    Body weight (kg) will be measured

    Time frame: The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

  2. Evaluation of Body Mass Index (BMI)

    BMI will be calculated as person's weight in kilograms divided by the square of height in meters

    Time frame: The measurement of the baseline BMI between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

  3. Evaluation of Foot Morphological Characteristics

    Foot width (cm) will be measured

    Time frame: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

  4. Evaluation of Foot Morphological Characteristics

    Foot length (cm) will be measured

    Time frame: The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

  5. Evaluation of foot mobility

    Navicular drop values will be measured

    Time frame: The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

  6. Evaluation of foot posture

    Foot posture will be evaluated according to foot posture index.

    Time frame: The measurement of the baseline foot posture characteristics between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

07

Study locations

1 site
  • İstanbul Medeniyet University
    İstanbul, Turkey
08

References and documents

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. PubMed 19208789 ↗
  • 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. PubMed 30794956 ↗
  • 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. PubMed 23117270 ↗
  • 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. PubMed 30352050 ↗
  • 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. PubMed 28167175 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05318001
Lead sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible party
Sponsor
First posted
Apr 8, 2022
Start date
May 1, 2022
Primary completion
May 15, 2024
Completion
Aug 1, 2024
Last update
Mar 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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