Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study

NCT ID: NCT05308121

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnant Women

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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First trimester pregnant women (first pregnancy)

This group will consist of women in the first trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Evaluation of biomechanics and viscoelastic properties of Achilles tendon

Intervention Type OTHER

The biomechanical and viscoelastic properties of the Achilles tendon will be measured in the side lying position. Measurements will be taken from two different points with the ankle in the neutral position.

Evaluation of foot characteristics

Intervention Type OTHER

The mobility of foot, morphological changes of foot and foot posture will be evaluated

Second trimester pregnant women (first pregnancy)

This group will consist of women in the second trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Evaluation of biomechanics and viscoelastic properties of Achilles tendon

Intervention Type OTHER

The biomechanical and viscoelastic properties of the Achilles tendon will be measured in the side lying position. Measurements will be taken from two different points with the ankle in the neutral position.

Evaluation of foot characteristics

Intervention Type OTHER

The mobility of foot, morphological changes of foot and foot posture will be evaluated

Third trimester pregnant women (first pregnancy)

This group will consist of women in the third trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon

Evaluation of biomechanics and viscoelastic properties of Achilles tendon

Intervention Type OTHER

The biomechanical and viscoelastic properties of the Achilles tendon will be measured in the side lying position. Measurements will be taken from two different points with the ankle in the neutral position.

Evaluation of foot characteristics

Intervention Type OTHER

The mobility of foot, morphological changes of foot and foot posture will be evaluated

Interventions

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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 two different points with the ankle in the neutral position.

Intervention Type OTHER

Evaluation of foot characteristics

The mobility of foot, morphological changes of foot and foot posture will be evaluated

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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İstanbul Medeniyet University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 9201635 (View on PubMed)

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.

Reference Type RESULT
PMID: 12576258 (View on PubMed)

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.

Reference Type RESULT
PMID: 29332731 (View on PubMed)

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.

Reference Type RESULT
PMID: 7550955 (View on PubMed)

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.

Reference Type RESULT
PMID: 33071278 (View on PubMed)

Other Identifiers

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20

Identifier Type: -

Identifier Source: org_study_id

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