Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

Taibah University

Status: Completed

Conditions: Flexible Flatfoot

Treatments: Device: Prefabricated Foot Orthosis; Device: 3D Printed Foot Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05896917

CMR-PO-2023-421/8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Experimental

Experimental group

Description:

This group will receive 3D Printed Foot Orthoses

Treatment:

Device: 3D Printed Foot Orthosis

Control

Active Comparator group

Description:

This group will receive Prefabricated Foot Orthoses

Treatment:

Device: Prefabricated Foot Orthosis