Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2023-08-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Flexible Flatfoot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental

This group will receive 3D Printed Foot Orthoses

Group Type EXPERIMENTAL

3D Printed Foot Orthosis

Intervention Type DEVICE

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

Control

This group will receive Prefabricated Foot Orthoses

Group Type ACTIVE_COMPARATOR

Prefabricated Foot Orthosis

Intervention Type DEVICE

Generic foot orthoses available commercially

Interventions

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3D Printed Foot Orthosis

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

Intervention Type DEVICE

Prefabricated Foot Orthosis

Generic foot orthoses available commercially

Intervention Type DEVICE

Other Intervention Names

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Insoles

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes