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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | This group will receive 3D Printed Foot Orthoses |
|
| Control | Active Comparator | This group will receive Prefabricated Foot Orthoses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Printed Foot Orthosis | Device | 3D printed foot orthoses designed and fabricated at the Taibah University |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abu Z Bari, PhD | Taibah University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Rehabilitation Hospital | Madinah | Medina Region | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38958259 | Derived | Bari AZ, Ahmed N, Farhan M, Al-Shenqiti A, Zafar MS. Comparing Prefabricated and 3D-Printed Foot Orthoses for the Management of Flat Foot Condition: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):298-304. doi: 10.1097/PHM.0000000000002585. Epub 2024 Jul 3. |
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All IPD that underlie results in this study
immediately following publication till after 2 years
Access to data will be determined by Taibah University's CMRS ethical committee. Authorized individuals, including researchers and institutions, can access participant data for research and validation. Requests undergo review based on scientific merit, requester qualifications, data use, and compliance. Secure data transfer methods are employed to prioritize confidentiality.
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Prefabricated Foot Orthosis | Device | Generic foot orthoses available commercially |
|
|
| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |