Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

• Sponsor: Taibah University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05896917
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.6
• Patients Per Site Per Month: 36.6

Study Details

Study Description

Brief 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 eight weeks. After ten weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.

Condition or Disease	Intervention/Treatment	Phase
Flexible Flatfoot	Device: 3D Printed Foot Orthosis; Device: Prefabricated Foot Orthosis	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
• Actual Study Start Date: May 23, 2023
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Aug 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental This group will receive 3D Printed Foot Orthoses	Device: 3D Printed Foot Orthosis; 3D printed foot orthoses designed and fabricated at the Taibah University
Active Comparator: Control This group will receive Prefabricated Foot Orthoses	Device: Prefabricated Foot Orthosis; Generic foot orthoses available commercially; Other Names: Insoles

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale [Will be measured at Week 0]

   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.

2. Visual Analog Scale [Will be measured at Week 4]

   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.

3. Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire. [Will be measured at 4th week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Rehabilitation Hospital	Medina	Al Madinah	Saudi Arabia

Sponsors and Collaborators

• Taibah University

Investigators

• Principal Investigator: Abu Z Bari, PhD, Taibah University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Abu Zeeshan Bari, Principal Investigator, Taibah University
• ClinicalTrials.gov Identifier: NCT05896917
• Other Study ID Numbers: CMR-PO-2023-421/8
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Flatfoot

Study Results

No Results Posted as of Jun 13, 2023