Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Tibialis Posterior Muscle Morphology Assessment

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Symptomatic Flexible Flatfoot1 intervention
Group B: Asymptomatic Flexible Flatfoot1 intervention
Group C: Normal Foot Posture (Control)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline assessment during a single study visit.
2

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.

Time frame
Baseline assessment during a single study visit.

Secondary outcomes

1

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.

Time frame
Baseline assessment during a single study visit.
2

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.

Time frame
Baseline assessment during a single study visit.
3

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.

Time frame
Baseline assessment during a single study visit.

Other outcomes

Sponsors and contacts

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