Clinical trial NCT05308121: Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study
Official title: Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Keywords: pregnant women
achilles tendon
stiffness
creep
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-01
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 (first pregnancy)

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 pilot 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.


Eligibility criteria: Inclusion Criteria:

* First 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 achilles tendon
timeFrame: Measurement the baseline stiffness values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
measure: Evaluation of biomechanical properties of achilles tendon
timeFrame: Measurement the baseline decrement values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
measure: Evaluation of biomechanical properties of achilles tendon
timeFrame: Measurement the baseline tone values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
measure: Evaluation of viscoelastic properties of achilles tendon
timeFrame: Measurement the baseline creep values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
measure: Evaluation of viscoelastic properties of achilles tendon
timeFrame: Measurement the baseline relaxation time values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Secondary outcomes:
measure: Evaluation of Body Weight
timeFrame: Measurement the baseline body weight (kg) between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
measure: Evaluation of Body Mass Index (BMI)
timeFrame: Measurement the baseline BMI values at 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 morphological properties
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 morphological properties
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 posture
timeFrame: The measurement of the baseline foot posturebetween 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
citation: Dumas GA, Reid JG. Laxity of knee cruciate ligaments during pregnancy. J Orthop Sports Phys Ther. 1997 Jul;26(1):2-6. doi: 10.2519/jospt.1997.26.1.2.
citation: Marnach ML, Ramin KD, Ramsey PS, Song SW, Stensland JJ, An KN. Characterization of the relationship between joint laxity and maternal hormones in pregnancy. Obstet Gynecol. 2003 Feb;101(2):331-5. doi: 10.1016/s0029-7844(02)02447-x.
citation: Orner S, Kratzer W, Schmidberger J, Gruner B. Quantitative tissue parameters of Achilles tendon and plantar fascia in healthy subjects using a handheld myotonometer. J Bodyw Mov Ther. 2018 Jan;22(1):105-111. doi: 10.1016/j.jbmt.2017.06.015. Epub 2017 Jun 21.
citation: Snow SW, Bohne WH, DiCarlo E, Chang VK. Anatomy of the Achilles tendon and plantar fascia in relation to the calcaneus in various age groups. Foot Ankle Int. 1995 Jul;16(7):418-21. doi: 10.1177/107110079501600707.
citation: Chang TT, Feng YN, Zhu Y, Liu CL, Wang XQ, Zhang ZJ. Objective Assessment of Regional Stiffness in Achilles Tendon in Different Ankle Joint Positions Using the MyotonPRO. Med Sci Monit. 2020 Oct 19;26:e926407. doi: 10.12659/MSM.926407.