Biomechanical Characterisation of 3D Printed Comfort Insoles

Biomechanical and Satisfaction Analysis of 3D Printed Comfort Insoles

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: 3D printed insole testing

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • University of Pécs

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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: Treatment	Other: 3D printed insole testing; 3D printed comfort insole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
spinal and postural assessment	Diers Formetric 4D (surface topography / spinal posture): 3D surface topography of the back (no radiation)Trunk imbalance / lateral deviation Spinal curvature angles: thoracic kyphosis, lumbar lordosis, scoliosis-related measures: vertebral lateral deviation, scoliosis angle / "Cobb equivalent", Vertebral rotation, hump height, pelvic parameters: pelvic inclination, pelvic torsion, Sagittal and coronal vertical balance, shoulder imbalance, symmetry indices and change over time, knee flexion, ankle flexion, in degrees (°)	3 weeks

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Principal Investigator: Luca Tóth, M.D PhD, University of Pécs Neurosurgery Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 16779-6/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The blinded pooled data will be shared

Drug and device information, study documents

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