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Completed

NCT Number: NCT05896917

Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Rehabilitation Hospital

Madinah, Medina Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Printed Foot Orthosis

Device

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

Prefabricated Foot Orthosis

Device

Generic foot orthoses available commercially

Other names: Insoles

Primary outcomes

  1. Visual Analog Scale

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taibah University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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