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Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

Primary Purpose

Flexible Flatfoot

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
3D Printed Foot Orthosis
Prefabricated Foot Orthosis
Sponsored by
Taibah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexible Flatfoot

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

This group will receive 3D Printed Foot Orthoses

This group will receive Prefabricated Foot Orthoses

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
August 23, 2023
Sponsor
Taibah University
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1. Study Identification

Unique Protocol Identification Number
NCT05896917
Brief Title
Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses
Official Title
Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taibah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexible Flatfoot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
This group will receive 3D Printed Foot Orthoses
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will receive Prefabricated Foot Orthoses
Intervention Type
Device
Intervention Name(s)
3D Printed Foot Orthosis
Intervention Description
3D printed foot orthoses designed and fabricated at the Taibah University
Intervention Type
Device
Intervention Name(s)
Prefabricated Foot Orthosis
Other Intervention Name(s)
Insoles
Intervention Description
Generic foot orthoses available commercially
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Will be measured at Week 0
Title
Visual Analog Scale
Description
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.
Time Frame
Will be measured at Week 4
Title
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire.
Description
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.
Time Frame
Will be measured at 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abu Z Bari, PhD
Organizational Affiliation
Taibah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Rehabilitation Hospital
City
Medina
State/Province
Al Madinah
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

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