Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study

NCT ID: NCT05318001

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

2022-05-01

Study Completion Date

2024-08-01

Brief Summary

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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.

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 and in first trimester of pregnancy

Evaluation of biomechanics and viscoelastic properties of plantar fascia

Intervention Type OTHER

The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position.

Evaluation of Foot Morphological Characteristics

Intervention Type OTHER

Foot length and width will be measured.

Evaluation of navıcular mobility

Intervention Type OTHER

The amount of navicular drop of both feet will be measured.

Evaluation of Foot Posture

Intervention Type OTHER

Foot posture will be evaluated according to Foot Posture Index.

Second trimester pregnant women (first pregnancy)

This group will consist of women in the second trimester and in first trimester of pregnancy

Evaluation of biomechanics and viscoelastic properties of plantar fascia

Intervention Type OTHER

The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position.

Evaluation of Foot Morphological Characteristics

Intervention Type OTHER

Foot length and width will be measured.

Evaluation of navıcular mobility

Intervention Type OTHER

The amount of navicular drop of both feet will be measured.

Evaluation of Foot Posture

Intervention Type OTHER

Foot posture will be evaluated according to Foot Posture Index.

Third trimester pregnant women (first pregnancy)

This group will consist of women in the third trimester and in first trimester of pregnancy

Evaluation of biomechanics and viscoelastic properties of plantar fascia

Intervention Type OTHER

The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position.

Evaluation of Foot Morphological Characteristics

Intervention Type OTHER

Foot length and width will be measured.

Evaluation of navıcular mobility

Intervention Type OTHER

The amount of navicular drop of both feet will be measured.

Evaluation of Foot Posture

Intervention Type OTHER

Foot posture will be evaluated according to Foot Posture Index.

Interventions

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Evaluation of biomechanics and viscoelastic properties of plantar fascia

The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position.

Intervention Type OTHER

Evaluation of Foot Morphological Characteristics

Foot length and width will be measured.

Intervention Type OTHER

Evaluation of navıcular mobility

The amount of navicular drop of both feet will be measured.

Intervention Type OTHER

Evaluation of Foot Posture

Foot posture will be evaluated according to Foot Posture Index.

Intervention Type OTHER

Eligibility Criteria

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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
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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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.

Reference Type RESULT
PMID: 19208789 (View on PubMed)

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.

Reference Type RESULT
PMID: 30794956 (View on PubMed)

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.

Reference Type RESULT
PMID: 23117270 (View on PubMed)

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.

Reference Type RESULT
PMID: 30352050 (View on PubMed)

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.

Reference Type RESULT
PMID: 28167175 (View on PubMed)

Other Identifiers

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21

Identifier Type: -

Identifier Source: org_study_id

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