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NCT Number: NCT07755215

Acute Effects of Foot Orthoses on Muscle Mechanical Properties in Individuals With Pes Planus

This randomized controlled study will examine the acute effects of a medial arch support and a prefabricated insole on lower-limb muscle mechanical properties and pain in young adults with pes planus. Ninety participants will be allocated in a 1:1:1 ratio to a medial arch support group, an insole group, or a control group. Muscle mechanical and viscoelastic properties will be assessed with MyotonPRO, and pain will be assessed with a visual analog scale.

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Key information

About this study

Participants will first undergo baseline assessments, followed by 30 minutes of treadmill walking at a self-selected speed and 0° incline while wearing comfortable shoes without an added orthosis. Dynamic stiffness, oscillation frequency, other MyotonPRO parameters, and pain will then be reassessed (T0). Participants in the medial arch support and insole groups will rest for 30 minutes and complete a second 30-minute walk at the same speed and incline with the assigned device placed inside the shoe. Outcomes will be reassessed immediately after this walk (T1). Participants in the control group will complete the study after the first, unassisted walking condition and T0 assessment; no T1 measurement is planned for this group. MyotonPRO assessments will include the tibialis anterior, peroneus longus, and medial and lateral gastrocnemius-soleus muscle groups, following the measurement procedures specified in the ethics application.

The control group will characterize the acute response to the initial unassisted walking task. Because the approved protocol does not include a second walking condition for the control group, analyses requiring T1 will be limited to the two orthosis groups. Between-group comparisons involving all three groups will use the time points available across all groups, including baseline and T0.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-30 years
  • Diagnosed with unilateral or bilateral pes planus
  • Willing to participate voluntarily in the study

Exclusion criteria

  • History of lower-extremity injury or surgery within the past 6 months
  • Diagnosis of a rheumatologic or neurological condition that may affect foot joint alignment
  • Skin lesions or damage that may prevent the measurements from being performed
  • Current use of an orthosis, such as an insole or wedge, to support pes planus
  • Body mass index (BMI) ≥25 kg/m² or ≤18.5 kg/m²
  • Unwilling to participate in the study

Treatment and study plan

Insole

Device

An insole will be placed inside the participant's shoe and used during a 30-minute treadmill walking session at a self-selected speed.

medial arch support

Device

A medial arch support will be placed inside the participant's shoe and used during a 30-minute treadmill walking session at a self-selected speed.

Primary outcomes

  1. Change in Muscle Dynamic Stiffness

    Time frame: Baseline, immediately after the first 30-minute treadmill walking session (T0), and immediately after the second 30-minute walking session following a 30-minute rest period (T1)

    Muscle dynamic stiffness will be measured using the MyotonPRO device and reported in newtons per meter (N/m). Higher values indicate greater muscle stiffness.

  2. Change in Muscle Oscillation Frequency

    Time frame: Baseline, immediately after the first 30-minute treadmill walking session (T0), and immediately after the second 30-minute walking session following a 30-minute rest period (T1). T1 measurements will only be performed in the medial arch support and insol

    Muscle oscillation frequency will be measured using the MyotonPRO device and reported in hertz (Hz). Higher values indicate greater muscle tone.

Secondary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline, immediately after the first 30-minute treadmill walking session (T0), and immediately after the second 30-minute walking session following a 30-minute rest period (T1). T1 measurements will only be performed in the medial arch support and insol

    Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Onur Koksal, PhD

CONTACT

[email protected]

+90 553 321 8117

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Acute Effects of Orthosis Use on Muscle Mechanical Properties in Individuals With Pes Planus: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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