Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Study Overview
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Brief Summary
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The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.

Official Title
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Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot

Conditions
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Flatfoot

Intervention / Treatment
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* Device: CAD/CAM Insole
* Device: Semi-custom Insole
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer), minimum of + 6 points on the foot posture index, Exclusion Criteria: treatment of the foot for at least six months, leg length discrepancy of more than 1 cm, history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAD/CAM<br>8-week follow-up with CAD/CAM insole and home based exercise program | Device: CAD/CAM Insole<br>* A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.<br>|
| Experimental: Semi-custom<br>8-week follow-up with semi-custom insole and home based exercise program | Device: Semi-custom Insole<br>* Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.<br>|
| Placebo Comparator: Control<br>8-week follow-up with placebo insole and home based exercise program | Other: Control<br>* 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity Measured by 100 mm Visual Analog Scale | The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results. | Baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Assessed With Short Form-36 Scale | The scale scores the health related quality of life with 0 and 100, minimum and maximum levels. Each question is scored between 0-100 and the total score is found by dividing to number of question. Higher score or positive change mean better quality of life in the scale. We used physical health part of it. Changes were calculated as the difference between 8-week follow-up and baseline results. | Baseline and week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthotic insoles, pain, quality of life, athletic performance