Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

Flexible Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896917
• Other study ID #: CMR-PO-2023-421/8
• Status: Completed
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: August 8, 2023

Study information

• Verified date: August 2023
• Source: Taibah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 8, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Flatfoot
• Flexible Flatfoot

Intervention

Device:
• 3D Printed Foot Orthosis
3D printed foot orthoses designed and fabricated at the Taibah University
• Prefabricated Foot Orthosis
Generic foot orthoses available commercially

Locations

Country	Name	City	State
Saudi Arabia	Medical Rehabilitation Hospital	Medina	Al Madinah

Sponsors (1)

Lead Sponsor	Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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