Clinical trial NCT05318001: Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
Official title: Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Keywords: stiffness
creep
normative data
plantar fascia
pregnant women
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women in the first- trimester, second trimester or third trimester (first-time pregnancy)

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of biomechanical properties of plantar fascia
timeFrame: The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
measure: Evaluation of biomechanical properties of plantar fascia
timeFrame: The measurement of the baseline decrement values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of biomechanical properties of plantar fascia
timeFrame: The measurement of the baseline tone values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of viscoelastic properties of plantar fascia
timeFrame: The measurement of the baseline creep values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of viscoelastic properties of plantar fascia
timeFrame: The measurement of the baseline relaxation time values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Secondary outcomes:
measure: Evaluation of Body Weight
timeFrame: The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of Body Mass Index (BMI)
timeFrame: The measurement of the baseline BMI between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of Foot Morphological Characteristics
timeFrame: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of Foot Morphological Characteristics
timeFrame: The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of foot mobility
timeFrame: The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of foot posture
timeFrame: The measurement of the baseline foot posture characteristics between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
citation: 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.
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.
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.
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. 2018 Oct 23;24:7570-7576. doi: 10.12659/MSM.909550.
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.