Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05318001
Collaborator
(none)
163
1
17.8
9.2

Study Details

Study Description

Brief Summary

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia
  • Other: Evaluation of Foot Morphological Characteristics
  • Other: Evaluation of navıcular mobility
  • Other: Evaluation of Foot Posture

Study Design

Study Type:
Observational
Anticipated Enrollment :
163 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
Oct 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Group: Pregnant women (first-timed pregnant)

This group will consist of women in first trimester of pregnancy

Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia
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.

Other: Evaluation of Foot Morphological Characteristics
Foot length and width will be measured.

Other: Evaluation of navıcular mobility
The amount of navicular drop of both feet will be measured.

Other: Evaluation of Foot Posture
Foot posture will be evaluated according to Foot Posture Index.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of biomechanical properties of plantar fascia [The measurement of the changes from baseline stiffness values of plantar fascia at 12., 22. and 34. 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 [The measurement of the changes from baseline decrement values of plantar fascia at 12., 22. and 34. weeks.]

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

  3. Evaluation of biomechanical properties of plantar fascia [The measurement of the changes from baseline tone values of plantar fascia at 12., 22. and 34. 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 [The measurement of the changes from baseline creep values of plantar fascia at 12., 22. and 34. 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 [The measurement of the changes from baseline relaxation time values of plantar fascia at 12., 22. and 34. weeks.]

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

Secondary Outcome Measures

  1. Evaluation of Body Weight [The measurement of the changes from baseline body weight at 12., 22. and 34. weeks.]

    Body weight (kg) will be measured

  2. Evaluation of Body Mass Index (BMI) [The measurement of the changes from baseline BMI at 12., 22. and 34. 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 [The measurement of the changes from baseline foot width at 12., 22. and 34. weeks.]

    Foot width (cm) will be measured

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

    Foot length (cm) will be measured

  5. 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

  6. Evaluation of foot posture [The measurement of the changes from baseline foot posture characteristics 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-time 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 İstanbul 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:
NCT05318001
Other Study ID Numbers:
  • 21
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 18, 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 18, 2022