Pregnant WomenNCT05318001
Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
An observational study of Pregnant Women, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Evaluation of biomechanics and viscoelastic properties of plantar fascia, Evaluation of Foot Morphological Characteristics and Evaluation of navıcular mobility
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in the first- trimester, second trimester or third trimester (first-time pregnancy)
Who may be able to join
- First-time pregnancy
- They are between the ages of 18-40
- Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
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.
- Conditions
- Pregnant Women
- Being tested
- Evaluation of biomechanics and viscoelastic properties of plantar fascia, Evaluation of Foot Morphological Characteristics, Evaluation of navıcular mobility, Evaluation of Foot Posture
- Keywords
- stiffness, creep, normative data, plantar fascia, pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of biomechanics and viscoelastic properties of plantar fasciaOther
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 CharacteristicsOther
Foot length and width will be measured.
Evaluation of navıcular mobilityOther
The amount of navicular drop of both feet will be measured.
Evaluation of Foot PostureOther
Foot posture will be evaluated according to Foot Posture Index.
| Study group | Role | What they receive |
|---|---|---|
| First trimester pregnant women (first pregnancy) | This group will consist of women in the first trimester and in first trimester of pregnancy Receives: Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia; Other: Evaluation of Foot Morphological Characteristics; Other: Evaluation of navıcular mobility; Other: Evaluation of Foot Posture | |
| Second trimester pregnant women (first pregnancy) | This group will consist of women in the second trimester and in first trimester of pregnancy Receives: Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia; Other: Evaluation of Foot Morphological Characteristics; Other: Evaluation of navıcular mobility; Other: Evaluation of Foot Posture | |
| Third trimester pregnant women (first pregnancy) | This group will consist of women in the third trimester and in first trimester of pregnancy Receives: Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia; Other: Evaluation of Foot Morphological Characteristics; Other: Evaluation of navıcular mobility; Other: Evaluation of Foot Posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of biomechanical properties of plantar fascia
Measuring of the stiffness (N/m) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Measured: The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Evaluation of biomechanical properties of plantar fascia
Measuring of the decrement of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Measured: The measurement of the baseline decrement values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of biomechanical properties of plantar fascia
Measuring of the tone (Hz) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Measured: The measurement of the baseline tone values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of viscoelastic properties of plantar fascia
Measuring of the creep of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Measured: The measurement of the baseline creep values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of viscoelastic properties of plantar fascia
Measuring of the relaxation time (ms) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Measured: The measurement of the baseline relaxation time values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Secondary outcomes (6)
Evaluation of Body Weight
Body weight (kg) will be measured
Measured: The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of Body Mass Index (BMI)
BMI will be calculated as person's weight in kilograms divided by the square of height in meters
Measured: The measurement of the baseline BMI between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of Foot Morphological Characteristics
Foot width (cm) will be measured
Measured: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of Foot Morphological Characteristics
Foot length (cm) will be measured
Measured: The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of foot mobility
Navicular drop values will be measured
Measured: The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of foot posture
Foot posture will be evaluated according to foot posture index.
Measured: The measurement of the baseline foot posture characteristics between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 May 2022
- Primary completion15 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318001
- Sponsor's protocol ID
- 21
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19208789Cherni 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.
PubMed 30794956Segal 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.
PubMed 23117270Huang 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.
PubMed 30352050Sanjana 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.
PubMed 28167175
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study
- ClinicalTrials.gov ID
- NCT05318001
- Acronym / sponsor ID
- 21
- Conditions
- Pregnant Women
- Keywords
- stiffness, creep, normative data, plantar fascia, pregnant women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First trimester pregnant women (first pregnancy) | – | Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia, Other: Evaluation of Foot Morphological Characteristics, Other: Evaluation of navıcular mobility, Other: Evaluation of Foot PostureThis group will consist of women in the first trimester and in first trimester of pregnancy |
| Second trimester pregnant women (first pregnancy) | – | Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia, Other: Evaluation of Foot Morphological Characteristics, Other: Evaluation of navıcular mobility, Other: Evaluation of Foot PostureThis group will consist of women in the second trimester and in first trimester of pregnancy |
| Third trimester pregnant women (first pregnancy) | – | Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia, Other: Evaluation of Foot Morphological Characteristics, Other: Evaluation of navıcular mobility, Other: Evaluation of Foot PostureThis group will consist of women in the third trimester and in first trimester of pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in the first- trimester, second trimester or third trimester (first-time pregnancy)
Key inclusion criteria (3 listed)
- First-time pregnancy
- They are between the ages of 18-40
- Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of biomechanics and viscoelastic properties of plantar fasciaThe 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. | Other | First trimester pregnant women (first pregnancy), Second trimester pregnant women (first pregnancy), Third trimester pregnant women (first pregnancy) |
| Evaluation of Foot Morphological CharacteristicsFoot length and width will be measured. | Other | First trimester pregnant women (first pregnancy), Second trimester pregnant women (first pregnancy), Third trimester pregnant women (first pregnancy) |
| Evaluation of navıcular mobilityThe amount of navicular drop of both feet will be measured. | Other | First trimester pregnant women (first pregnancy), Second trimester pregnant women (first pregnancy), Third trimester pregnant women (first pregnancy) |
| Evaluation of Foot PostureFoot posture will be evaluated according to Foot Posture Index. | Other | First trimester pregnant women (first pregnancy), Second trimester pregnant women (first pregnancy), Third trimester pregnant women (first pregnancy) |
Primary outcome
Evaluation of biomechanical properties of plantar fascia
Time frame: The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Measuring of the stiffness (N/m) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of biomechanical properties of plantar fascia
Time frame: The measurement of the baseline decrement values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the decrement of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of biomechanical properties of plantar fascia
Time frame: The measurement of the baseline tone values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the tone (Hz) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of viscoelastic properties of plantar fascia
Time frame: The measurement of the baseline creep values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the creep of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of viscoelastic properties of plantar fascia
Time frame: The measurement of the baseline relaxation time values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the relaxation time (ms) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
6 secondary outcomes
Evaluation of Body Weight
Time frame: The measurement of the baseline body weight between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of Body Mass Index (BMI)
Time frame: The measurement of the baseline BMI between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of Foot Morphological Characteristics
Time frame: The measurement of the baseline foot width between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of Foot Morphological Characteristics
Time frame: The measurement of the baseline foot length between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of foot mobility
Time frame: The measurement of the baseline navicular drop values between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of foot posture
Time frame: The measurement of the baseline foot posture characteristics between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Results publication: PubMed 19208789Challis 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.
- Results publication: PubMed 30794956Cherni 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.
- Results publication: PubMed 23117270Segal 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.
- Results publication: PubMed 30352050Huang 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.
- Results publication: PubMed 28167175Sanjana 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of biomechanical properties of plantar fascia (time frame: The measurement of the baseline stiffness values of plantar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318001, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.