Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women

Pregnant Women Clinical Trial

Official title:

Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05308121
• Other study ID #: 20
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: October 15, 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 163
• Est. completion date: October 15, 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 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 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	I?stanbul

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Dumas GA, Reid JG. Laxity of knee cruciate ligaments during pregnancy. J Orthop Sports Phys Ther. 1997 Jul;26(1):2-6. — View 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. — View Citation

Orner S, Kratzer W, Schmidberger J, Grüner 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of biomechanical properties of achilles tendon	Measuring of the stiffness (N/m) of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	Measurement the change from baseline stiffness values of Achilles tendon at 12. week, at 22. week and at 34. week.
Primary	Evaluation of biomechanical properties of achilles tendon	Measuring of the decrement of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	Measurement the change from baseline decrement values of Achilles tendon at 12. week, at 22. week and at 34. week.
Primary	Evaluation of biomechanical properties of achilles tendon	Measuring of the tone (Hz) of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	Measurement the change from baseline tone values of Achilles tendon at 12. week, at 22. week and at 34. week.
Primary	Evaluation of viscoelastic properties of achilles tendon	Measuring of the creep of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	Measurement the change from baseline creep values of Achilles tendon at 12. week, at 22. week and at 34. week.
Primary	Evaluation of viscoelastic properties of achilles tendon	Measuring of the relaxation time (ms) of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	Measurement the change from baseline relaxation time values of Achilles tendon at 12. week, at 22. week and at 34. week.
Secondary	Evaluation of Body Weight	Measuring of the Body Weight	Measurement the change from baseline body weight (kg) at 12., 22. and 34. weeks.
Secondary	Evaluation of Body Mass Index (BMI)	BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.	Measurement the change from baseline BMI values 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 morphological properties	Foot length will be measured	The measurement of the changes from baseline foot length at 12., 22. and 34. weeks.
Secondary	Evaluation of foot morphological properties	Foot width will be measured	The measurement of the changes from baseline foot width 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 at 12., 22. and 34. weeks.