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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07755215
Enrollment
90
Registered
2026-08-10
Start date
2026-09-01
Completion date
2027-02-28
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flatfoot

Keywords

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

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.

Detailed description

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.

Interventions

DEVICEInsole

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

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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded to group allocation. The statistician will analyze the data using coded group labels.

Intervention model description

1. Medial Arch Support Group 2. Insole Group 3. Control Group

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Muscle Dynamic StiffnessBaseline, 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.
Change in Muscle Oscillation FrequencyBaseline, 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 insolMuscle oscillation frequency will be measured using the MyotonPRO device and reported in hertz (Hz). Higher values indicate greater muscle tone.

Secondary

MeasureTime frameDescription
Change in Pain IntensityBaseline, 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 insolPain 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.

Contacts

CONTACTOnur Koksal, PhD
onur.koksal@medipol.edu.tr+90 553 321 8117
PRINCIPAL_INVESTIGATOROnur Koksal

Medipol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026