Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women

Completed

• Conditions: Pregnant Women
• Interventions: Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics

• Registration Number: NCT05308121
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-31
• Study Start: 2022-04-01
• Study First Posted: 2022-04-01
• Primary Completion: 2024-05-15
• Study Completion: 2024-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 172

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
First trimester pregnant women (first pregnancy)	Evaluation of biomechanics and viscoelastic properties of Achilles tendon	This group will consist of women in the first trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon
First trimester pregnant women (first pregnancy)	Evaluation of foot characteristics	This group will consist of women in the first trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon
Second trimester pregnant women (first pregnancy)	Evaluation of biomechanics and viscoelastic properties of Achilles tendon	This group will consist of women in the second trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon
Second trimester pregnant women (first pregnancy)	Evaluation of foot characteristics	This group will consist of women in the second trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon
Third trimester pregnant women (first pregnancy)	Evaluation of biomechanics and viscoelastic properties of Achilles tendon	This group will consist of women in the third trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon
Third trimester pregnant women (first pregnancy)	Evaluation of foot characteristics	This group will consist of women in the third trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Primary Outcome Measures

Name	Time	Method
Evaluation of biomechanical properties of achilles tendon	Measurement the baseline tone values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	Measuring of the tone (Hz) of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of viscoelastic properties of achilles tendon	Measurement the baseline relaxation time values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	Measuring of the relaxation time (ms) of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Body Weight	Measurement the baseline body weight (kg) between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	Measuring of the Body Weight
Evaluation of Body Mass Index (BMI)	Measurement the baseline BMI values at between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.
Evaluation of foot mobility	The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	Navicular drop values will be measured
Evaluation of foot morphological properties	The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	Foot width will be measured
Evaluation of foot posture	The measurement of the baseline foot posturebetween 10-14 weeks, between 20-24 weeks and between 32-36 weeks.	Foot posture will be evaluated according to foot posture index

Trial Locations

Locations (1)

İstanbul Medeniyet University; 🇹🇷 İ̇stanbul, Turkey