Pronated FootNCT07298629
Product Information Analysis and Clinical Verification - Clinical Verification of New Smart Health Medical Shoes/Insoles
A study testing 3d printed insole in people with Pronated Foot, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pronated Foot
- What is being tested?
- 3d printed insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obvious medial arch collapse
- Foot posture index (FPI) score of 6 or higher
Who cannot join
- experience wearing custom-made insoles within the past 6 months;
- experience of lower limb injury, surgery, acute infection, or other complications within the past 6 months
- a body mass index (BMI) greater than 35;
- rheumatoid arthritis;
- cognitive impairment preventing obedience;
- systemic diseases affecting the nervous, muscular, skeletal, or circulatory systems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
JO-EN CHIEN, MS contact
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy
Taipei, 100
YUEH-HSIA Chen, PhD, +886-2-3366-8133, yuehhsiachen@ntu.edu.tw
About this study
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.
- Conditions
- Pronated Foot
- Being tested
- 3d printed insole
- Keywords
- 3D printed insoles, foot pressure, physical performance, motion analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed insoleDevice
This study used 3D printer, producing customized insoles with selective laser sintering (SLS) technology.
| Study group | Role | What they receive |
|---|---|---|
| 3D customized insole | Experimental | Not described Receives: Device: 3d printed insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot pressure
Measured: Baseline, Week 1, Week 4
Foot functional Index
Measured: Baseline, Week 1, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pronated FootStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298629
- Sponsor's protocol ID
- 202311043RIPA
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Product Information Analysis and Clinical Verification - Clinical Verification of New Smart Health Medical Shoes/Insoles
- ClinicalTrials.gov ID
- NCT07298629
- Acronym / sponsor ID
- 202311043RIPA
- Conditions
- Pronated Foot
- Keywords
- 3D printed insoles, foot pressure, physical performance, motion analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D customized insole | Experimental | Device: 3d printed insole |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obvious medial arch collapse
- Foot posture index (FPI) score of 6 or higher
Key exclusion criteria (6 listed)
- experience wearing custom-made insoles within the past 6 months;
- experience of lower limb injury, surgery, acute infection, or other complications within the past 6 months
- a body mass index (BMI) greater than 35;
- rheumatoid arthritis;
- cognitive impairment preventing obedience;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3d printed insoleThis study used 3D printer, producing customized insoles with selective laser sintering (SLS) technology. | Device | 3D customized insole |
Primary outcome
Foot pressure
Time frame: Baseline, Week 1, Week 4
Foot functional Index
Time frame: Baseline, Week 1, Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JO-EN CHIEN, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed insole in people with Pronated Foot, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YUEH-HSIA CHEN, PhD (+886-3366-8133, yuehhsiachen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot pressure (time frame: Baseline, Week 1, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.