Biomechanical Characterisation of 3D Printed Comfort Insoles
9. juni 2026 opdateret af: Luca Tóth, University of Pecs
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Baranya
-
Pécs, Baranya, Ungarn, 7624
- University of Pecs
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Behandling
|
3D printed comfort insole
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Likert based satisfaction analysis
Tidsramme: 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 |
3 weeks
|
|
temporal-spatial gait parameters
Tidsramme: 3 weeks
|
Pedogait system (plantar pressure & gait analysis): - temporal-spatial gait: step length, stride length, center of pressure trajectory in cms |
3 weeks
|
|
gait timing measures
Tidsramme: 3 weeks
|
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
Tidsramme: 3 weeks
|
peak plantar pressure by region (heel, midfoot, forefoot, toes), pressure distribution by foot region in Newton (N)
|
3 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
spinal and postural assessment
Tidsramme: 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 (°)
|
3 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Luca Tóth, M.D PhD, University of Pécs Neurosurgery Clinic
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. maj 2024
Primær færdiggørelse (Anslået)
15. juli 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
1. juni 2026
Først indsendt, der opfyldte QC-kriterier
9. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 16779-6/2024
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
The blinded pooled data will be shared
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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