Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition. The main question it aims to answer is: If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles. If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles. Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.

Detailed Description
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The purpose of this research is to compare the effects of 3D printed insoles versus prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. They will be divided into groups of an equal number of people. Prefabricated insoles will be given to one group, while 3D printed insoles will be given to the other. Subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. Statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. The results will help us in identifying which insoles are better than the other in terms of parameters described above.

Official Title
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Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study

Conditions
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Flexible Flatfoot

Intervention / Treatment
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* Device: 3D Printed Foot Orthosis
* Device: Prefabricated Foot Orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or above Flatfoot symptoms such as foot/calf pain and fatigue after prolonged walking Foot postural index ranging from 6 to 12 No neurological or physical disabilities Exclusion Criteria: Below 18 years of age Inability to understand or answer questions Any lower limb surgery within the past two years Any lower limb injury within the past six months Any neurological disorder affecting gait

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>This group will receive 3D Printed Foot Orthoses | Device: 3D Printed Foot Orthosis<br>* 3D printed foot orthoses designed and fabricated at the Taibah University<br>|
| Active Comparator: Control<br>This group will receive Prefabricated Foot Orthoses | Device: Prefabricated Foot Orthosis<br>* Generic foot orthoses available commercially<br>* Other names: Insoles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | The Visual Analog Scale is a validated tool for assessing pain. It involves a 10-centimeter line with the starting point at 0 centimeters representing no pain and the end point at 10 centimeters representing severe pain. Patients mark their pain level on the line, and the distance from the starting point provides a numerical measure of pain intensity. | Will be measured at Week 0 | 
| Visual Analog Scale | The Visual Analog Scale is a validated tool for assessing pain. It involves a 10-centimeter line with the starting point at 0 centimeters representing no pain and the end point at 10 centimeters representing severe pain. Patients mark their pain level on the line, and the distance from the starting point provides a numerical measure of pain intensity. | Will be measured at Week 4 | 
| Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire. | The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) questionnaire is a tool designed to assess user satisfaction with assistive technology (AT) devices. A modified version of the QUEST questionnaire that will be used here consists of various items related to different aspects of assistive device use, such as device effectiveness, comfort, durability, weight, and dimensions. Respondents will be asked to rate each item on a scale, ranging from 1 (Not Satisfied at All) to 5 (Very Satisfied), indicating their level of satisfaction with each statement. | Will be measured at 4th week |