An interventional study of Insole and Medial Arch Support in Flatfoot, sponsored by Medipol University. Not yet recruiting. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
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.
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.
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 122 interventional studies indexed under Flatfoot.
Browse Flatfoot studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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)
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.
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
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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 3 months is below that.
Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.