Trials / Completed
CompletedNCT05896917
Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses
Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Taibah University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 3D Printed Foot Orthosis | 3D printed foot orthoses designed and fabricated at the Taibah University |
| DEVICE | Prefabricated Foot Orthosis | Generic foot orthoses available commercially |
Timeline
- Start date
- 2023-05-23
- Primary completion
- 2023-07-30
- Completion
- 2023-08-08
- First posted
- 2023-06-09
- Last updated
- 2023-08-25
Locations
1 site across 1 country: Saudi Arabia
Source: ClinicalTrials.gov record NCT05896917. Inclusion in this directory is not an endorsement.