Skip to main content
OpenTrials
Completed

NCT Number: NCT05308121

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnant Women

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Evaluation of foot characteristics

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.