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Product Information Analysis and Clinical Verification - Clinical Verification of New Smart Health Medical Shoes/Insoles

NCT ID: NCT07298629

Last Updated: 2025-12-23

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-12-31

Brief Summary

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As part of foot orthotics, insoles play a crucial role in adjusting biomechanical malalignments of the foot and regulating foot pressure. They are commonly used as a clinical tool for correcting foot problems. Currently, most customized insole manufacturing processes mainly depend on traditional or subtractive methods, highly dependent on the manual technology of the manufacturer, and the production capacity is constrained by working hours and cannot be manufactured in large quantities. Consequently, people often need to wait for one to two months with poor timeliness. The 3D printing insole fabrication process offers significant advantages in customization with high design flexibility and freedom. Utilizing microstructural zoning designs can better combine different regional characteristic requirements, thus closely addressing individual requirements. The purpose of this project is to validate the medical process after the initial development of the novel intelligent health medical insole and subsequently introduce the new intelligent health medical insole into clinical applications within medical institutions.

The project plans to recruit 30 participants with foot pain. Participants will be required to provide basic information and evaluated their foot condition. the Tiger Scan 3D full-foot scanning equipment will be used to capture the participants' 3D foot models. Insoles will be customized based on the assessment results, incorporating features such as heel cups, arch supports, and medial wedges. Relevant parameters will be uploaded to a RESTful API correction information platform. Then, the clinical recommendations for adjustment parameters will be output to a 3D printer, producing customized insoles with selective laser sintering (SLS) technology. The outcome assessments encompass short-term and long-term evaluations. Short-term assessments include kinematics and dynamic analysis, foot pressure distribution, physical performance, and foot morphology. Long-term assessments include pain levels, activities of daily living, and changes in quality of life.

Detailed Description

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Conditions

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Pronated Foot

Keywords

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3D printed insoles foot pressure physical performance motion analysis

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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3D customized insole

Group Type EXPERIMENTAL

3d printed insole

Intervention Type DEVICE

This study used 3D printer, producing customized insoles with selective laser sintering (SLS) technology.

Interventions

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3d printed insole

This study used 3D printer, producing customized insoles with selective laser sintering (SLS) technology.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Obvious medial arch collapse
2. Foot posture index (FPI) score of 6 or higher

Exclusion Criteria

1. experience wearing custom-made insoles within the past 6 months;
2. experience of lower limb injury, surgery, acute infection, or other complications within the past 6 months
3. a body mass index (BMI) greater than 35;
4. rheumatoid arthritis;
5. cognitive impairment preventing obedience;
6. systemic diseases affecting the nervous, muscular, skeletal, or circulatory systems
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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School and Graduate Institute of Physical Therapy

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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YUEH-HSIA CHEN, PhD

Role: CONTACT

Phone: +886-3366-8133

Email: [email protected]

JO-EN CHIEN, MS

Role: CONTACT

Email: [email protected]

Facility Contacts

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YUEH-HSIA Chen, PhD

Role: primary

Other Identifiers

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202311043RIPA

Identifier Type: -

Identifier Source: org_study_id