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

NCT07755215 | Not Yet Recruiting

• 1 other identifier: 1562
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Flatfoot

Keywords

flatfoot; pes planus; foot orthoses; muscle mechanical properties; myotonPRO

Outcome Measures

Primary Outcomes (2)

• Change in Muscle Dynamic Stiffness

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

  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)

• Change in Muscle Oscillation Frequency

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

  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

Secondary Outcomes (1)

• Change in Pain Intensity

  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

Study Arms (3)

Medial Arch Support Group

EXPERIMENTAL

Participants will walk on a treadmill for 30 minutes at a self-selected speed without arch support. After the post-walk assessment and a 30-minute rest period, they will repeat the same walking protocol with a medial arch support placed inside their shoes. Muscle mechanical properties and pain will be assessed before and after the walking sessions.

Device: Medial Arch Support

Insole Group

EXPERIMENTAL

Participants will walk on a treadmill for 30 minutes at a self-selected speed without an insole. After the post-walk assessment and a 30-minute rest period, they will repeat the same walking protocol with an insole placed inside their shoes. Muscle mechanical properties and pain will be assessed before and after the walking sessions.

Device: Insole

Control Group

NO INTERVENTION

Participants will walk on a treadmill for 30 minutes at a self-selected speed without an arch support or insole. Muscle mechanical properties and pain will be assessed before and after the walking session. No additional walking session with an orthotic intervention will be performed.

Interventions

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.

Insole Group

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.

Medial Arch Support Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

MeSH Terms

Conditions

Flatfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Onur Koksal

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onur Koksal, PhD

CONTACT

+90 553 321 8117; onur.koksal@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation. The statistician will analyze the data using coded group labels.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1. Medial Arch Support Group 2. Insole Group 3. Control Group

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share