New smart 3D-printed medical insoles and shoes clinical verification
Official title: Product Information Analysis and Clinical Verification - Clinical Verification of New Smart Health Medical Shoes/Insoles
Run by National Taiwan University Hospital · NCT07298629 · Data updated 2026-11-12
This project tests whether smart 3D-printed insoles improve foot pressure distribution and biomechanics for people with pronated feet and collapsed medial arches.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 65 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07298629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with obvious medial arch collapse and an FPI score of 6 or higher who have not used custom-made insoles or had recent lower-limb injuries or surgery and have a BMI of 35 or less.
✕Probably not a fit
People with recent lower-limb injury or surgery, BMI over 35, rheumatoid arthritis, systemic neuromuscular or circulatory disease, cognitive impairment, or who used custom insoles in the past six months are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with pronated feet and a foot posture index of 6 or higher will receive custom 3D-printed insoles designed with microstructural zoning to target regional foot pressures. The project will follow a clinical verification process comparing baseline measures of foot pressure, gait and physical performance to outcomes after using the new insoles. Motion analysis and pressure-mapping tools will be used to quantify biomechanical changes and usability. The effort also aims to validate the manufacturing and medical workflow for faster, highly customizable insole production.
Why it matters
Potential benefit: If successful, these insoles could relieve abnormal pressure, improve gait mechanics, and provide faster-access custom orthotics for people with pronated feet.
How similar studies have gone: Prior small-scale work on custom and 3D-printed insoles has shown promising short-term improvements in pressure distribution and comfort, but long-term and large-scale evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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School and Graduate Institute of Physical Therapy
Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: YUEH-HSIA CHEN, PhD
- Email: yuehhsiachen@ntu.edu.tw
- Phone: +886-3366-8133
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.