Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

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

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.

Study Overview

• Status: Completed
• Conditions: Flexible Flatfoot
• Intervention / Treatment: Device: 3D Printed Foot Orthosis; Device: Prefabricated Foot Orthosis

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Madinah
    • Medina, Al Madinah, Saudi Arabia
      • Medical Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: CMR-PO-2023-421/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in this study
• IPD Sharing Time Frame: immediately following publication till after 2 years
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No