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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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