Healthy
Conditions
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.
Interventions
OTHER3D printed insole testing
3D printed comfort insole
Sponsors
University of Pecs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likert based satisfaction analysis | 3 weeks | 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 |
| temporal-spatial gait parameters | 3 weeks | Pedogait system (plantar pressure \& gait analysis): \- temporal-spatial gait: step length, stride length, center of pressure trajectory in cms |
| gait timing measures | 3 weeks | stride time, walking phase durations: stance-, swing time, single/double support contact time and timing of heel strike in seconds (s) |
| pressure distribution parameters | 3 weeks | peak plantar pressure by region (heel, midfoot, forefoot, toes), pressure distribution by foot region in Newton (N) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| spinal and postural assessment | 3 weeks | 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 (°) |
Countries
Hungary
Contacts
PRINCIPAL_INVESTIGATORLuca Tóth, M.D PhD
University of Pécs Neurosurgery Clinic
Outcome results
None listed