NCT07854535

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Oct 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

September 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Keywords

Flexible FlatfootTibialis Posterior MuscleMuscle MorphologyUltrasoundFoot PostureMuscle thicknessMuscle Cross sectional Area

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline assessment during a single study visit.

Secondary Outcomes (3)

  • Tibialis Posterior Muscle Stiffness

    Baseline assessment during a single study visit.

  • Foot Posture Index-6 (FPI-6)

    Baseline assessment during a single study visit.

  • Pain intensity level

    Baseline assessment during a single study visit.

Study Arms (3)

Symptomatic Flexible Flatfoot

Participants with flexible flatfoot who have foot-related symptoms.

Other: Tibialis Posterior Muscle Morphology Assessment

Asymptomatic Flexible Flatfoot

Participants with flexible flatfoot who do not have foot-related symptoms.

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.

Other: Tibialis Posterior Muscle Morphology Assessment

Interventions

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.

Asymptomatic Flexible FlatfootNormal Foot Posture (Control)Symptomatic Flexible Flatfoot

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University Cairo, Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nabil Abdo Abdellah Mohamed, PhD

    Ass. Professor, Cairo University

    STUDY CHAIR
  • Hatem Mohamed Said El-Azizi, PhD

    Professor, Cairo University

    STUDY DIRECTOR
  • Abdallah Mohamed Kamel, PhD

    Lecturer, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Hend Ahmed, B.Sc

CONTACT

Abdallah Mohamed Kamel, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations