Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study

NCT05308121 | Completed

• 1 other identifier: 20
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

There is anatomical fascial continuity and functional connection between the plantar fascia, which has important roles in foot biomechanics, and the fibers of the Achilles tendon, and the change that will occur in any of these tissues is reflected in the other. However, it has not been objectively clarified how the tissue properties of the Achilles tendon, which plays an important role in foot biomechanics, such as the plantar fascia, change with pregnancy. Therefore, the aim of this pilot study is to investigate the trimester-specific biomechanical (stiffness, decrement and tone) and viscoelastic (creep and relaxation time) properties of the Achilles tendon, which adapts to changes in the foot structure during pregnancy.

Conditions

Pregnant Women

Keywords

pregnant women; achilles tendon; stiffness; creep

Outcome Measures

Primary Outcomes (5)

• Evaluation of biomechanical properties of achilles tendon

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

  Measurement the baseline stiffness values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

• Evaluation of biomechanical properties of achilles tendon

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

  Measurement the baseline decrement values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

• Evaluation of biomechanical properties of achilles tendon

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

  Measurement the baseline tone values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

• Evaluation of viscoelastic properties of achilles tendon

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

  Measurement the baseline creep values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

• Evaluation of viscoelastic properties of achilles tendon

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

  Measurement the baseline relaxation time values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

Secondary Outcomes (6)

• Evaluation of Body Weight

  Measurement the baseline body weight (kg) between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

• Evaluation of Body Mass Index (BMI)

  Measurement the baseline BMI values at 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.

• Evaluation of foot morphological properties

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

• Evaluation of foot morphological properties

  The measurement of the baseline foot width 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 of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics

Second trimester pregnant women (first pregnancy)

This group will consist of women in the second trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics

Third trimester pregnant women (first pregnancy)

This group will consist of women in the third trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics

Interventions

Evaluation of biomechanics and viscoelastic properties of Achilles tendon OTHER

The biomechanical and viscoelastic properties of the Achilles tendon will be measured in the side lying position. Measurements will be taken from two different points with the ankle in the neutral position.

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

Evaluation of foot characteristics OTHER

The mobility of foot, morphological changes of foot and foot posture will be evaluated

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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women (first pregnancy)

You may qualify if:

• First 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)

• Dumas GA, Reid JG. Laxity of knee cruciate ligaments during pregnancy. J Orthop Sports Phys Ther. 1997 Jul;26(1):2-6. doi: 10.2519/jospt.1997.26.1.2.

  PMID: 9201635 RESULT

• Marnach ML, Ramin KD, Ramsey PS, Song SW, Stensland JJ, An KN. Characterization of the relationship between joint laxity and maternal hormones in pregnancy. Obstet Gynecol. 2003 Feb;101(2):331-5. doi: 10.1016/s0029-7844(02)02447-x.

  PMID: 12576258 RESULT

• Orner S, Kratzer W, Schmidberger J, Gruner B. Quantitative tissue parameters of Achilles tendon and plantar fascia in healthy subjects using a handheld myotonometer. J Bodyw Mov Ther. 2018 Jan;22(1):105-111. doi: 10.1016/j.jbmt.2017.06.015. Epub 2017 Jun 21.

  PMID: 29332731 RESULT

• Snow SW, Bohne WH, DiCarlo E, Chang VK. Anatomy of the Achilles tendon and plantar fascia in relation to the calcaneus in various age groups. Foot Ankle Int. 1995 Jul;16(7):418-21. doi: 10.1177/107110079501600707.

  PMID: 7550955 RESULT

• Chang TT, Feng YN, Zhu Y, Liu CL, Wang XQ, Zhang ZJ. Objective Assessment of Regional Stiffness in Achilles Tendon in Different Ankle Joint Positions Using the MyotonPRO. Med Sci Monit. 2020 Oct 19;26:e926407. doi: 10.12659/MSM.926407.

  PMID: 33071278 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 1, 2022
• Study Start: April 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)