FlatfootNCT07755215
Acute Effects of Foot Orthoses on Muscle Mechanical Properties in Individuals With Pes Planus
A study testing Insole and Medial Arch Support in people with Flatfoot, run by Medipol University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Flatfoot
- What is being tested?
- Insole and Medial Arch Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-30 years
- Diagnosed with unilateral or bilateral pes planus
- Willing to participate voluntarily in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Effects of Orthosis Use on Muscle Mechanical Properties in Individuals With Pes Planus: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Flatfoot
- Being tested
- Insole, Medial Arch Support
- Keywords
- flatfoot, pes planus, foot orthoses, muscle mechanical properties, myotonPRO
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsoleDevice
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 SupportDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Medial Arch Support Group 2. Insole Group 3. Control Group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Köksal, Medipol University
- Investigators
- Onur Koksal, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755215
- Sponsor's protocol ID
- 1562
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Orthosis Use on Muscle Mechanical Properties in Individuals With Pes Planus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07755215
- Acronym / sponsor ID
- 1562
- Conditions
- Flatfoot
- Keywords
- flatfoot, pes planus, foot orthoses, muscle mechanical properties, myotonPRO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Medial Arch Support Group 2. Insole Group 3. Control Group
| Arm | Type | Receives |
|---|---|---|
| Medial Arch Support Group | Experimental | Device: Medial Arch SupportParticipants 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. |
| Insole Group | Experimental | Device: InsoleParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-30 years
- Diagnosed with unilateral or bilateral pes planus
- Willing to participate voluntarily in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsoleAn insole will be placed inside the participant's shoe and used during a 30-minute treadmill walking session at a self-selected speed. | Device | Insole Group |
| Medial Arch SupportA 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. | Device | Medial Arch Support Group |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Onur Koksal principal investigator
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing Insole and Medial Arch Support in people with Flatfoot, run by Medipol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Onur Koksal, PhD (+90 553 321 8117, onur.koksal@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.