Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

Pregnant Women Clinical Trial

Official title:

Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05318001
• Other study ID #: 21
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: October 25, 2023

Study information

• Verified date: March 2022
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Nilüfer KABLAN, PhD
• Phone: 05067638556
• Email: niluferkablan[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 163
• Est. completion date: October 25, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

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.
• Evaluation of Foot Morphological Characteristics
Foot length and width will be measured.
• Evaluation of navicular mobility
The amount of navicular drop of both feet will be measured.
• Evaluation of Foot Posture
Foot posture will be evaluated according to Foot Posture Index.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Challis JR, Lockwood CJ, Myatt L, Norman JE, Strauss JF 3rd, Petraglia F. Inflammation and pregnancy. Reprod Sci. 2009 Feb;16(2):206-15. doi: 10.1177/1933719108329095. Review. — View Citation

Cherni Y, Desseauve D, Decatoire A, Veit-Rubinc N, Begon M, Pierre F, Fradet L. Evaluation of ligament laxity during pregnancy. J Gynecol Obstet Hum Reprod. 2019 May;48(5):351-357. doi: 10.1016/j.jogoh.2019.02.009. Epub 2019 Feb 20. — View Citation

Huang J, Qin K, Tang C, Zhu Y, Klein CS, Zhang Z, Liu C. Assessment of Passive Stiffness of Medial and Lateral Heads of Gastrocnemius Muscle, Achilles Tendon, and Plantar Fascia at Different Ankle and Knee Positions Using the MyotonPRO. Med Sci Monit. 201 — View Citation

Sanjana F, Chaudhry H, Findley T. Effect of MELT method on thoracolumbar connective tissue: The full study. J Bodyw Mov Ther. 2017 Jan;21(1):179-185. doi: 10.1016/j.jbmt.2016.05.010. Epub 2016 Jun 3. — View Citation

Segal NA, Boyer ER, Teran-Yengle P, Glass NA, Hillstrom HJ, Yack HJ. Pregnancy leads to lasting changes in foot structure. Am J Phys Med Rehabil. 2013 Mar;92(3):232-40. doi: 10.1097/PHM.0b013e31827443a9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of biomechanical properties of plantar fascia	Measuring of the stiffness (N/m) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	The measurement of the changes from baseline stiffness values of plantar fascia at 12., 22. and 34. weeks.
Primary	Evaluation of biomechanical properties of plantar fascia	Measuring of the biomechanical decrement of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	The measurement of the changes from baseline decrement values of plantar fascia at 12., 22. and 34. weeks.
Primary	Evaluation of biomechanical properties of plantar fascia	Measuring of the tone (Hz) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	The measurement of the changes from baseline tone values of plantar fascia at 12., 22. and 34. weeks.
Primary	Evaluation of viscoelastic properties of plantar fascia	Measuring of the creep of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	The measurement of the changes from baseline creep values of plantar fascia at 12., 22. and 34. weeks.
Primary	Evaluation of viscoelastic properties of plantar fascia	Measuring of the relaxation time (ms) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	The measurement of the changes from baseline relaxation time values of plantar fascia at 12., 22. and 34. weeks.
Secondary	Evaluation of Body Weight	Body weight (kg) will be measured	The measurement of the changes from baseline body weight at 12., 22. and 34. weeks.
Secondary	Evaluation of Body Mass Index (BMI)	BMI will be calculated as person's weight in kilograms divided by the square of height in meters	The measurement of the changes from baseline BMI at 12., 22. and 34. weeks.
Secondary	Evaluation of Foot Morphological Characteristics	Foot width (cm) will be measured	The measurement of the changes from baseline foot width at 12., 22. and 34. weeks.
Secondary	Evaluation of Foot Morphological Characteristics	Foot length (cm) will be measured	The measurement of the changes from baseline foot length at 12., 22. and 34. weeks.
Secondary	Evaluation of foot mobility	Navicular drop values will be measured	The measurement of the changes from baseline navicular drop values at 12., 22. and 34. weeks.
Secondary	Evaluation of foot posture	Foot posture will be evaluated according to foot posture index.	The measurement of the changes from baseline foot posture characteristics at 12., 22. and 34. weeks.