Flexible FlatfootNCT07854535
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
An observational study of Flexible Flatfoot, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study is to assess tibialis posterior muscle morphology in adults with flexible flatfeet. The main question it aims to answer is: Are there differences in tibialis posterior muscle morphology between adults with symptomatic flexible flatfeet, asymptomatic flexible flatfeet, and… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- Tibialis Posterior Muscle Morphology Assessment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from individuals attending the outpatient clinics of the Faculty of Physical Therapy, Cairo University, and New Cairo Hospital. The study population will include individuals presenting with different foot postures, including those with flexible flatfoot and individuals with normal foot posture. Eligible participants who meet the study criteria and provide informed consent will be enrolled in the study.
Who may be able to join
- Adults aged 18 to 40 years.
- Both males and females will be eligible to participate.
- Body mass index (BMI) ≤30 kg/m².
- Participants with flexible flatfoot will demonstrate a visible medial longitudinal arch in the non-weight-bearing position and flattening of the arch during full weight-bearing.
- Participants with flexible flatfoot will have a Foot Posture Index-6 (FPI-6) score of ≥+6.
- Participants in the normal foot posture control group will have an FPI-6 score ranging from 0 to +5.
- Participants must be able to stand and walk independently without an assistive device.
- Participants must be willing to participate in the study and provide informed consent.
Who cannot join
- History of previous surgery involving the foot, ankle, or lower limb.
- History of significant trauma or fracture involving the foot, ankle, or lower limb.
- Presence of rigid flatfoot or other structural foot deformities.
- Presence of neurological disorders affecting the lower limb.
- Presence of neuromuscular disorders affecting the lower limb.
- Presence of systemic or inflammatory musculoskeletal conditions affecting the lower limb.
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- Current lower-limb injury or condition that may affect standing, walking, foot posture, or tibialis posterior muscle morphology.
- Pregnancy.
- Participants who are unable to follow the assessment procedures or complete the required study measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdallah Mohamed Kamel, PhD contact
Egypt1 site
Faculty of Physical Therapy, Cairo University Cairo, Egypt
Cairo
Hend Ahmed Mansour Elhabyan, B.Sc, +20 11 13097799, hendahmed63@gmail.com
About this study
Official title: Assessment of Tibialis Posterior Muscle Morphology in Subjects With Flexible Flatfeet
The goal of this observational study is to assess tibialis posterior muscle morphology in adults with flexible flatfeet. The main question it aims to answer is:
Are there differences in tibialis posterior muscle morphology between adults with symptomatic flexible flatfeet, asymptomatic flexible flatfeet, and individuals with normal foot posture?
Participants will undergo clinical assessment of foot posture and symptoms and an ultrasound assessment of the tibialis posterior muscle. The study will compare muscle thickness, cross-sectional area, and echo intensity among the three groups.
Read the detailed description
Flexible flatfoot involves altered mechanics of the foot and may influence the functional demands placed on the structures responsible for maintaining the medial longitudinal arch. The tibialis posterior muscle is an important dynamic contributor to medial arch support and plays a role in controlling pronation and maintaining foot stability during functional activities.
Although flexible flatfoot has been widely investigated from clinical and biomechanical perspectives, less is known about the morphological characteristics of the tibialis posterior muscle in relation to this condition. In particular, differences associated with the presence or absence of symptoms have not been sufficiently characterized. Evaluating muscle morphology may provide additional information about the muscular adaptations associated with altered foot posture.
The rationale for this study is to investigate whether the morphological characteristics of the tibialis posterior muscle differ across individuals with different clinical presentations of foot posture. Comparing these characteristics may help clarify whether muscular morphological changes are associated with flexible flatfoot itself or with the presence of symptoms.
The study findings may contribute to a better understanding of the muscular component of flexible flatfoot and provide information that may be useful for future research investigating assessment and rehabilitation strategies for individuals with this condition.
- Conditions
- Flexible Flatfoot
- Being tested
- Tibialis Posterior Muscle Morphology Assessment
- Keywords
- Flexible Flatfoot, Tibialis Posterior Muscle, Muscle Morphology, Ultrasound, Foot Posture, Muscle thickness, Muscle Cross sectional Area
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibialis Posterior Muscle Morphology AssessmentOther
Assessment of tibialis posterior muscle morphology using B-mode diagnostic ultrasound as a non-invasive measurement method. The assessment is performed for research purposes and does not involve administration of treatment or modification of participants' usual care.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Flexible Flatfoot | Participants with flexible flatfoot who have foot-related symptoms. Receives: Other: Tibialis Posterior Muscle Morphology Assessment | |
| Asymptomatic Flexible Flatfoot | Participants with flexible flatfoot who do not have foot-related symptoms. Receives: Other: Tibialis Posterior Muscle Morphology Assessment | |
| Normal Foot Posture (Control) | Participants with normal foot posture who do not meet the study criteria for flexible flatfoot. Receives: Other: Tibialis Posterior Muscle Morphology Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibialis Posterior Muscle Thickness
Tibialis posterior muscle thickness will be assessed using B-mode diagnostic ultrasonography with a high-frequency linear transducer. The ultrasound measurement site will be standardized at 30% of the shank length according to the predefined study protocol. Minimal transducer pressure will be applied to avoid muscle compression. Multiple images will be obtained, and the mean measurement will be used for statistical analysis.
Measured: Baseline assessment during a single study visit.
Tibialis Posterior Muscle Cross-sectional Area
Tibialis posterior muscle cross-sectional area will be assessed using B-mode diagnostic ultrasonography with a high-frequency linear transducer. The ultrasound measurement site will be standardized at 30% of the shank length according to the predefined study protocol. Minimal transducer pressure will be applied to avoid muscle compression. Multiple images will be obtained, and the mean cross-sectional area measurement will be used for statistical analysis.
Measured: Baseline assessment during a single study visit.
Secondary outcomes (3)
Tibialis Posterior Muscle Stiffness
Tibialis posterior muscle stiffness will be assessed using shear wave elastography (SWE) with an ultrasound system equipped with a high-frequency linear transducer. The ultrasound measurement site will be standardized at 30% of the shank length according to the predefined study protocol. Minimal transducer pressure will be applied to avoid muscle deformation. Multiple measurements will be obtained, and the mean stiffness value will be used for statistical analysis.
Measured: Baseline assessment during a single study visit.
Foot Posture Index-6 (FPI-6)
Foot posture will be assessed using the Foot Posture Index-6 (FPI-6) during relaxed standing. The FPI-6 consists of six observational and palpation-based items used to assess foot posture, with each item scored from -2 to +2. The total score ranges from -12 to +12, with higher scores indicating a more pronated foot posture.
Measured: Baseline assessment during a single study visit.
Pain intensity level
Pain intensity will be assessed using the Arabic version of the Numeric Pain Rating Scale (Arabic NPRS). Participants will rate their foot-related pain on a numerical scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. The Arabic NPRS will be administered according to its validated Arabic version.
Measured: Baseline assessment during a single study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Ahmed Mansour, Cairo University
- Investigators
- Nabil Abdo Abdellah Mohamed, PhD, Study chair, Ass. Professor, Cairo UniversityHatem Mohamed Said El-Azizi, PhD, Study director, Professor, Cairo UniversityAbdallah Mohamed Kamel, PhD, Study director, Lecturer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854535
- Sponsor's protocol ID
- P.T.REC/012/006294
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tibialis Posterior Muscle Morphology in Subjects With Flexible Flatfeet
- ClinicalTrials.gov ID
- NCT07854535
- Acronym / sponsor ID
- P.T.REC/012/006294
- Conditions
- Flexible Flatfoot
- Keywords
- Flexible Flatfoot, Tibialis Posterior Muscle, Muscle Morphology, Ultrasound, Foot Posture, Muscle thickness, Muscle Cross sectional Area
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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 goal of this observational study is to assess tibialis posterior muscle morphology in adults with flexible flatfeet. The main question it aims to answer is:
Are there differences in tibialis posterior muscle morphology between adults with symptomatic flexible flatfeet, asymptomatic flexible flatfeet, and individuals with normal foot posture?
Participants will undergo clinical assessment of foot posture and symptoms and an ultrasound assessment of the tibialis posterior muscle. The study will compare muscle thickness, cross-sectional area, and echo intensity among the three groups.
Detailed description
Flexible flatfoot involves altered mechanics of the foot and may influence the functional demands placed on the structures responsible for maintaining the medial longitudinal arch. The tibialis posterior muscle is an important dynamic contributor to medial arch support and plays a role in controlling pronation and maintaining foot stability during functional activities.
Although flexible flatfoot has been widely investigated from clinical and biomechanical perspectives, less is known about the morphological characteristics of the tibialis posterior muscle in relation to this condition. In particular, differences associated with the presence or absence of symptoms have not been sufficiently characterized. Evaluating muscle morphology may provide additional information about the muscular adaptations associated with altered foot posture.
The rationale for this study is to investigate whether the morphological characteristics of the tibialis posterior muscle differ across individuals with different clinical presentations of foot posture. Comparing these characteristics may help clarify whether muscular morphological changes are associated with flexible flatfoot itself or with the presence of symptoms.
The study findings may contribute to a better understanding of the muscular component of flexible flatfoot and provide information that may be useful for future research investigating assessment and rehabilitation strategies for individuals with this condition.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Flexible Flatfoot | – | Other: Tibialis Posterior Muscle Morphology AssessmentParticipants with flexible flatfoot who have foot-related symptoms. |
| Asymptomatic Flexible Flatfoot | – | Other: Tibialis Posterior Muscle Morphology AssessmentParticipants with flexible flatfoot who do not have foot-related symptoms. |
| Normal Foot Posture (Control) | – | Other: Tibialis Posterior Muscle Morphology AssessmentParticipants with normal foot posture who do not meet the study criteria for flexible flatfoot. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from individuals attending the outpatient clinics of the Faculty of Physical Therapy, Cairo University, and New Cairo Hospital. The study population will include individuals presenting with different foot postures, including those with flexible flatfoot and individuals with normal foot posture. Eligible participants who meet the study criteria and provide informed consent will be enrolled in the study.
Key inclusion criteria (8 listed)
- Adults aged 18 to 40 years.
- Both males and females will be eligible to participate.
- Body mass index (BMI) ≤30 kg/m².
- Participants with flexible flatfoot will demonstrate a visible medial longitudinal arch in the non-weight-bearing position and flattening of the arch during full weight-bearing.
- Participants with flexible flatfoot will have a Foot Posture Index-6 (FPI-6) score of ≥+6.
Key exclusion criteria (9 listed)
- History of previous surgery involving the foot, ankle, or lower limb.
- History of significant trauma or fracture involving the foot, ankle, or lower limb.
- Presence of rigid flatfoot or other structural foot deformities.
- Presence of neurological disorders affecting the lower limb.
- Presence of neuromuscular disorders affecting the lower limb.
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 |
|---|---|---|
| Tibialis Posterior Muscle Morphology AssessmentAssessment of tibialis posterior muscle morphology using B-mode diagnostic ultrasound as a non-invasive measurement method. The assessment is performed for research purposes and does not involve administration of treatment or modification of participants' usual care. | Other | Asymptomatic Flexible Flatfoot, Normal Foot Posture (Control), Symptomatic Flexible Flatfoot |
Primary outcome
Tibialis Posterior Muscle Thickness
Time frame: Baseline assessment during a single study visit.
Tibialis posterior muscle thickness will be assessed using B-mode diagnostic ultrasonography with a high-frequency linear transducer. The ultrasound measurement site will be standardized at 30% of the shank length according to the predefined study protocol. Minimal transducer pressure will be applied to avoid muscle compression. Multiple images will be obtained, and the mean measurement will be used for statistical analysis.
Tibialis Posterior Muscle Cross-sectional Area
Time frame: Baseline assessment during a single study visit.
Tibialis posterior muscle cross-sectional area will be assessed using B-mode diagnostic ultrasonography with a high-frequency linear transducer. The ultrasound measurement site will be standardized at 30% of the shank length according to the predefined study protocol. Minimal transducer pressure will be applied to avoid muscle compression. Multiple images will be obtained, and the mean cross-sectional area measurement will be used for statistical analysis.
3 secondary outcomes
Tibialis Posterior Muscle Stiffness
Time frame: Baseline assessment during a single study visit.
Foot Posture Index-6 (FPI-6)
Time frame: Baseline assessment during a single study visit.
Pain intensity level
Time frame: Baseline assessment during a single study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Flexible Flatfoot
Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
Pediatric Flexible Flatfoot
Not yet recruiting
Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
Patellofemoral Joint, Flatfoot
Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Flexible Flatfoot or Pes Planus
Recruiting
Biofeedback-Assisted Short Foot Exercises in Flexible Flatfoot
Pes Planus
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.
Abdallah Mohamed Kamel, PhD contact
Nabil Abdo Abdellah Mohamed, PhD study chair
Ass. Professor, Cairo University
Hatem Mohamed Said El-Azizi, PhD study director
Professor, Cairo University
Abdallah Mohamed Kamel, PhD study director
Lecturer, Cairo University
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 Flexible Flatfoot, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hend Ahmed, B.Sc (+201113097799, hendahmed63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibialis Posterior Muscle Thickness (time frame: Baseline assessment during a single study visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.