Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses (NCT05896917) | Clinical Trial Compass
CompletedNot Applicable
Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses
Saudi Arabia95 participantsStarted 2023-05-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale
Timeframe: Will be measured at Week 0
2
Visual Analog Scale
Timeframe: Will be measured at Week 4
3
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire.