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The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot

NCT ID: NCT04381039

Last Updated: 2021-10-20

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-08-01

Brief Summary

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The aim of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

Detailed Description

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Functional flatfoot is a common foot disease which induces pain and functional decline. Insoles can be used for intervention and correction, especially customized insoles which are made according to different foot types. There have been few studies using 3D printing for customized insoles for functional flatfoot. Besides, compared to traditional method and subtractive manufacturing, the effect of 3D printing customized insoles is still controversial and depends on technology, materials and design.The purpose of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics. Twelve patients with functional flatfoot (foot function index\> 6) aged 20-65 years old will be recruited in this study. Participants plan to wear three kinds of customized insoles fabricated by 3D printing with Nylon and TPU or computer numerical control machine with EVA. F-Scan system and questionnaires will be used to record foot biomechanics and pain after wearing insoles immediately, and foot condition after three weeks. Statistical analysis will be adopted for repeated-measures analysis of variance （ANOVA） for all outcome measures and post-hoc test will be used to test the difference between groups.

Conditions

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Flexible Flatfoot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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customized insole group

Group Type EXPERIMENTAL

Insole

Intervention Type DEVICE

3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only

Interventions

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Insole

3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged between 20 and 65 years old
* Appearance of decreased medial arch
* Foot posture index score between 6 to 12

Exclusion Criteria

* History of injuries of the lower extremity within the past 6 months
* Experience of use of orthopedic insole within the past 6 months
* Acute disorders in the lower extremities and spine
* History of surgery on the lower extremities and lumbar spine within the past 6 months
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Physical therapy center, national Taiwan university hosipital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201909067DINA

Identifier Type: -

Identifier Source: org_study_id