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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04381039

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Flexible Flatfoot	Device: Insole	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: customized insole group	Device: Insole 3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only

Arm

Intervention/Treatment

Experimental: customized insole group

Device: Insole

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

Outcome Measures

Primary Outcome Measures

F-scan system [after wearing insole (immediate effect)]
measure peak plantar pressure, contact area, peak force and center of pressure excursion index during walking and center of pressure velocity and center of pressure 95% ellipse area during one leg stance by F-scan system

Secondary Outcome Measures

Visual analogue scale [after wearing insole (immediate effect)]
This scale is used to measure pain and wearing comfort during sitting, standing and walking. For pain measurement, the maximum value is 10, which means severe pain. The minimum value is 0, which means absence of pain. For comfort measurement, the maximum value is 10, which means most comfortable. The minimum value is 0, which means absence of comfort.
Foot function index [after wearing each insole for a week (at least 6 hours per day)]
Foot function index is used to measure foot condition. It contains 23 items, which are divided into three subscales: activity limitation, disability, and pain. The patient scores each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Higher scores indicates worse pain. Both total and subcategory scores are calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physical therapy center, national Taiwan university hosipital	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04381039

Other Study ID Numbers:

201909067DINA

First Posted:

May 8, 2020

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Flatfoot

Study Results

No Results Posted as of Oct 20, 2021