Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

NCT05896917 | Completed DMC

• 1 other identifier: CMR-PO-2023-421/8
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexible Flatfoot

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

This group will receive 3D Printed Foot Orthoses

Device: 3D Printed Foot Orthosis

Control

ACTIVE COMPARATOR

This group will receive Prefabricated Foot Orthoses

Device: Prefabricated Foot Orthosis

Interventions

3D Printed Foot Orthosis DEVICE

3D printed foot orthoses designed and fabricated at the Taibah University

Experimental

Prefabricated Foot Orthosis DEVICE

Generic foot orthoses available commercially

Also known as: Insoles

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Medical Rehabilitation Hospital

Madinah, Medina Region, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 38958259 DERIVED

MeSH Terms

Conditions

Flatfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Abu Z Bari, PhD

  Taibah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 9, 2023
• Study Start: May 23, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 8, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: immediately following publication till after 2 years
• 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.

Locations

SA (1)