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

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.

Study Overview

• Status: Recruiting
• Conditions: Pronated Foot
• Intervention / Treatment: Device: 3d printed insole

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YUEH-HSIA CHEN, PhD; Phone Number: +886-3366-8133; Email: yuehhsiachen@ntu.edu.tw
• Study Contact Backup: Name: JO-EN CHIEN, MS; Email: d10428002@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • School and Graduate Institute of Physical Therapy
    • Contact: YUEH-HSIA Chen, PhD; Phone Number: +886-2-3366-8133; Email: yuehhsiachen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D customized insole	Device: 3d printed insole; This study used 3D printer, producing customized insoles with selective laser sintering (SLS) technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Foot pressure	Baseline, Week 1, Week 4
Foot functional Index	Baseline, Week 1, Week 4

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: physical performance; motion analysis; foot pressure; 3D printed insoles
• Other Study ID Numbers: 202311043RIPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No