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Completed

NCT Number: NCT05318001

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

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.

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Key information

Conditions

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-time 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 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.

Evaluation of Foot Morphological Characteristics

Other

Foot length and width will be measured.

Evaluation of navıcular mobility

Other

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

Evaluation of Foot Posture

Other

Foot posture will be evaluated according to Foot Posture Index.

Primary outcomes

  1. Evaluation of biomechanical properties of plantar fascia

    Time frame: The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.

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

  2. Evaluation of biomechanical properties of plantar fascia

    Time frame: The measurement of the baseline decrement values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

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

  3. Evaluation of biomechanical properties of plantar fascia

    Time frame: The measurement of the baseline tone values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

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

  4. Evaluation of viscoelastic properties of plantar fascia

    Time frame: The measurement of the baseline creep values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

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

  5. Evaluation of viscoelastic properties of plantar fascia

    Time frame: The measurement of the baseline relaxation time values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

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

Secondary outcomes

  1. Evaluation of Body Weight

    Time frame: The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Body weight (kg) will be measured

  2. Evaluation of Body Mass Index (BMI)

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

    BMI will be calculated as person's weight in kilograms divided by the square of height in meters

  3. Evaluation of Foot Morphological Characteristics

    Time frame: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Foot width (cm) will be measured

  4. Evaluation of Foot Morphological Characteristics

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

    Foot length (cm) will be measured

  5. 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

  6. Evaluation of foot posture

    Time frame: The measurement of the baseline foot posture characteristics between 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 Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 8, 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.

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