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

NCT05318001 | Completed

• 1 other identifier: 21
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnant Women

Keywords

stiffness; creep; normative data; plantar fascia; pregnant women

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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

  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 Outcomes (6)

• Evaluation of Body Weight

  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)

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

• Evaluation of Foot Morphological Characteristics

  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

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

• Evaluation of foot mobility

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

Study Arms (3)

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

Evaluation of biomechanics and viscoelastic properties of plantar fascia OTHER

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.

First trimester pregnant women (first pregnancy); Second trimester pregnant women (first pregnancy); Third trimester pregnant women (first pregnancy)

Evaluation of Foot Morphological Characteristics OTHER

Foot length and width will be measured.

First trimester pregnant women (first pregnancy); Second trimester pregnant women (first pregnancy); Third trimester pregnant women (first pregnancy)

Evaluation of navıcular mobility OTHER

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

First trimester pregnant women (first pregnancy); Second trimester pregnant women (first pregnancy); Third trimester pregnant women (first pregnancy)

Evaluation of Foot Posture OTHER

Foot posture will be evaluated according to Foot Posture Index.

First trimester pregnant women (first pregnancy); Second trimester pregnant women (first pregnancy); Third trimester pregnant women (first pregnancy)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women in the first pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19208789 RESULT

• 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.

  PMID: 30794956 RESULT

• 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.

  PMID: 23117270 RESULT

• 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.

  PMID: 30352050 RESULT

• 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.

  PMID: 28167175 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: April 8, 2022
• Study Start: May 1, 2022
• Primary Completion: May 15, 2024
• Study Completion: August 1, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

TU (1)