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

March 21, 2025 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  • Turkey
      • İ̇stanbul, 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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women (first pregnancy)

Description

Inclusion Criteria:

  • First 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other: Evaluation of foot characteristics
The mobility of foot, morphological changes of foot and foot posture will be evaluated
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
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.
Other: Evaluation of foot characteristics
The mobility of foot, morphological changes of foot and foot posture will be evaluated
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
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.
Other: Evaluation of foot characteristics
The mobility of foot, morphological changes of foot and foot posture will be evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of biomechanical properties of achilles tendon
Time Frame: Measurement the baseline stiffness values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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
Time Frame: Measurement the baseline decrement values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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
Time Frame: Measurement the baseline tone values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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
Time Frame: Measurement the baseline creep values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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
Time Frame: Measurement the baseline relaxation time values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Body Weight
Time Frame: Measurement the baseline body weight (kg) between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Measuring of the 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)
Time Frame: Measurement the baseline BMI values at between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.
Measurement the baseline BMI values at 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 morphological properties
Time Frame: The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Foot length 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 morphological properties
Time Frame: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Foot width 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 posture
Time Frame: The measurement of the baseline foot posturebetween 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 posturebetween 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.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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

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)

April 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 1, 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

Keywords

Other Study ID Numbers

  • 20 (Sophies Minde Ortopedi AS)

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.

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