Health TrialsbyHealthPanel

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

ConditionFlatfoot
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorMedipol University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-30 years

Diagnosed with unilateral or bilateral pes planus

Willing to participate voluntarily in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Medial Arch Support GroupExperimental treatment 1 intervention
Group B: Insole GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)
2

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

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: