Pregnant WomenNCT05308121
Biomechanical and Viscoelastic Properties of Achilles Tendon 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
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. 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 Achilles tendon and Evaluation of foot characteristics
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 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 (first pregnancy)
Who may be able to join
- First 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 Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study
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.
- Conditions
- Pregnant Women
- Being tested
- Evaluation of biomechanics and viscoelastic properties of Achilles tendon, Evaluation of foot characteristics
- Keywords
- pregnant women, achilles tendon, stiffness, creep
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 Achilles tendonOther
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 characteristicsOther
The mobility of foot, morphological changes of foot and foot posture will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics | |
| 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 Receives: Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics | |
| 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 Receives: Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon; Other: Evaluation of foot characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement the baseline stiffness values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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.
Measured: Measurement the baseline decrement values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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.
Measured: Measurement the baseline tone values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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.
Measured: Measurement the baseline creep values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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.
Measured: Measurement the baseline relaxation time values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Secondary outcomes (6)
Evaluation of Body Weight
Measuring of the Body Weight
Measured: Measurement the baseline body weight (kg) between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
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.
Measured: Measurement the baseline BMI values at 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 morphological properties
Foot length 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 morphological properties
Foot width 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 posture
Foot posture will be evaluated according to foot posture index
Measured: The measurement of the baseline foot posturebetween 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 posted1 Apr 2022
- Study start1 Apr 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
- NCT05308121
- Sponsor's protocol ID
- 20
- 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
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.
PubMed 9201635Marnach 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.
PubMed 12576258Orner 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.
PubMed 29332731Snow 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.
PubMed 7550955Chang 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.
PubMed 33071278
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 Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study
- ClinicalTrials.gov ID
- NCT05308121
- Acronym / sponsor ID
- 20
- Conditions
- Pregnant Women
- Keywords
- pregnant women, achilles tendon, stiffness, creep
- 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 Apr 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 1 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.
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.
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 Achilles tendon, Other: Evaluation of foot characteristicsThis 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) | – | Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon, Other: Evaluation of foot characteristicsThis 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) | – | Other: Evaluation of biomechanics and viscoelastic properties of Achilles tendon, Other: Evaluation of foot characteristicsThis group will consist of women in the third trimester of pregnancy. Pregnant women will be evaluated 2 points of the Achilles Tendon |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women (first pregnancy)
Key inclusion criteria (3 listed)
- First 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 Achilles tendonThe 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. | Other | First trimester pregnant women (first pregnancy), Second trimester pregnant women (first pregnancy), Third trimester pregnant women (first pregnancy) |
| Evaluation of foot characteristicsThe mobility of foot, morphological changes of foot and foot posture will be evaluated | 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 achilles tendon
Time frame: Measurement the baseline stiffness values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Measuring of the stiffness (N/m) of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of biomechanical properties of achilles tendon
Time frame: Measurement the baseline decrement values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Measuring of the decrement of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of biomechanical properties of achilles tendon
Time frame: 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
Time frame: Measurement the baseline creep values of Achilles tendon between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Measuring of the creep of the achilles tendon (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of viscoelastic properties of achilles tendon
Time frame: 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.
6 secondary outcomes
Evaluation of Body Weight
Time frame: Measurement the baseline body weight (kg) between 10-14 weeks, between 20-24 weeks and between 32-36 weeks.
Evaluation of Body Mass Index (BMI)
Time frame: Measurement the baseline BMI values at 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 morphological properties
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 morphological properties
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 posture
Time frame: The measurement of the baseline foot posturebetween 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 9201635Dumas 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.
- Results publication: PubMed 12576258Marnach 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.
- Results publication: PubMed 29332731Orner 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.
- Results publication: PubMed 7550955Snow 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.
- Results publication: PubMed 33071278Chang 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.
- 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 achilles tendon (time frame: Measurement the baseline stiffness values of Achilles tendon 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 NCT05308121, 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.