Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05308121
Collaborator
(none)
163
1
18.5
8.8

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon

Study Design

Study Type:
Observational
Anticipated Enrollment :
163 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Group: Pregnant women (first pregnancy)

This group will consist of women in the first trimester of pregnancy. Pregnant women will be evaluated 3 times in total, each measurement being in a different trimester.

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 three different points with the ankle in the neutral position.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of biomechanical properties of achilles tendon [Measurement the change from baseline stiffness values of Achilles tendon at 12. week, at 22. week and at 34. week.]

    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 [Measurement the change from baseline decrement values of Achilles tendon at 12. week, at 22. week and at 34. week.]

    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 [Measurement the change from baseline tone values of Achilles tendon at 12. week, at 22. week and at 34. week.]

    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 [Measurement the change from baseline creep values of Achilles tendon at 12. week, at 22. week and at 34. week.]

    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 [Measurement the change from baseline relaxation time values of Achilles tendon at 12. week, at 22. week and at 34. week.]

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

Secondary Outcome Measures

  1. Evaluation of Body Weight [Measurement the change from baseline body weight (kg) at 12., 22. and 34. weeks.]

    Measuring of the Body Weight

  2. Evaluation of Body Mass Index (BMI) [Measurement the change from baseline BMI values at 12., 22. and 34. 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 [The measurement of the changes from baseline navicular drop values at 12., 22. and 34. weeks.]

    Navicular drop values will be measured

  4. Evaluation of foot morphological properties [The measurement of the changes from baseline foot length at 12., 22. and 34. weeks.]

    Foot length will be measured

  5. Evaluation of foot morphological properties [The measurement of the changes from baseline foot width at 12., 22. and 34. weeks.]

    Foot width will be measured

  6. Evaluation of foot posture [The measurement of the changes from baseline foot posture at 12., 22. and 34. weeks.]

    Foot posture will be evaluated according to foot posture index

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • First pregnancy

  • Being in the first trimester of 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul Medeniyet University İ̇stanbul Turkey

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT05308121
Other Study ID Numbers:
  • 20
First Posted:
Apr 1, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Results

No Results Posted as of Apr 1, 2022