Biomechanical Characterisation of 3D Printed Comfort Insoles

NCT07644429 | Active Not Recruiting

• 1 other identifier: 16779-6/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated force distribution, biomechanical changes, and user satisfaction after 3 weeks of wearing three dimensional (3D)-printed personalised comfort insoles in healthy and flat-footed adults. Institutional approval was obtained and participants (age 18-65) able to walk independently were enrolled, excluding pregnancy, neurologic gait disorders, or distal foot wounds. Baseline and follow-up static and dynamic plantar pressure and gait analyses were performed using Diers Pedoscan, Pedogait, and a pressure-integrated treadmill, with forces measured on ten plantar regions normalized to body weight plus spatio-temporal and kinematic parameters and center-of-pressure trajectories. Full-weight-bearing 3D foot scans were captured with an iQube E500 scanner, meshes processed in Foot3D, and anonymized for design. Insoles were digitally designed using LeoInsole artificial intelligence software that auto-detected anatomical landmarks and adjusted a base template, with manual tweaks as needed, targeting comfort features (arch, metatarsal pad, sulcus length) and 2.5-3.5 mm thickness. Final insole pairs were additively manufactured in Polyamide12 nylon via Hewlett-Packard Multi Jet Fusion, finished with a glued textile cover, and checked/adjusted by an orthotic technician at delivery. Participants wore the insoles at least 3 hours daily for 3 weeks and completed a 12-item 5-point Likert satisfaction questionnaire after follow-up testing. Flat foot was diagnosed from 3D models using the Chippaux-Smirak Index, but the same comfort insole design was used regardless of flat-foot status.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Likert based satisfaction analysis

  12 item 5 point Likert scale Q1. The insole is comfortable for wearing in my regular shoes, even for all-day wear Q2. The insole is comfortable for wearing in my regular shoes, for 1-2 hours maximum Q3. I am satisfied with the appearance of my insoles Q4. The design of the insole is suitable (it fits my foot size and my foot shape) Q5. My new insoles are more comfortable than my previous insoles Q6. I would recommend this technology and the insole to others Q7. My pain has been reduced by wearing insoles Q8. The insole did not move/slip when placed in my shoe during wear Q9. Insole comfort was unaffected by foot perspiration Q10. I am satisfied with the time it took to make the insoles (including sampling, production and delivery) Q11. The insoles did not damage my shoes Q12. Regardless of the study, I will use the insoles in the future

  3 weeks

• temporal-spatial gait parameters

  Pedogait system (plantar pressure \& gait analysis): \- temporal-spatial gait: step length, stride length, center of pressure trajectory in cms

  3 weeks

• gait timing measures

  stride time, walking phase durations: stance-, swing time, single/double support contact time and timing of heel strike in seconds (s)

  3 weeks

• pressure distribution parameters

  peak plantar pressure by region (heel, midfoot, forefoot, toes), pressure distribution by foot region in Newton (N)

  3 weeks

Secondary Outcomes (1)

• spinal and postural assessment

  3 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Other: 3D printed insole testing

Interventions

3D printed insole testing OTHER

3D printed comfort insole

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years, able to walk independently, with no significant cognitive deficit which may limit the cooperation, willing to use the insole for 3 weeks, 3 hours daily and signed informed consent

You may not qualify if:

• pregnancy during the study period, any neurologic deficit or trauma related pathology likely to alter normal gait, and any sores or injuries distal to the ankle joint

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

University of Pécs

Pécs, Baranya, 7624, Hungary

Location

Study Officials

• Luca Tóth, M.D PhD

  University of Pécs Neurosurgery Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Biomechanical Laboratory M.D. PhD.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 12, 2026
• Study Start: May 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)