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NCT Number: NCT07644429

Biomechanical Characterisation 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pécs

Pécs, Baranya, 7624, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D printed insole testing

Other

3D printed comfort insole

Primary outcomes

  1. Likert based satisfaction analysis

    Time frame: 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

  2. temporal-spatial gait parameters

    Time frame: 3 weeks

    Pedogait system (plantar pressure & gait analysis):

    • temporal-spatial gait: step length, stride length, center of pressure trajectory in cms

  3. gait timing measures

    Time frame: 3 weeks

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

  4. pressure distribution parameters

    Time frame: 3 weeks

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

Secondary outcomes

  1. spinal and postural assessment

    Time frame: 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 (°)

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

Biomechanical and Satisfaction Analysis of 3D Printed Comfort Insoles

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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