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临床试验/NCT07644429
NCT07644429进行中(未招募)不适用

Biomechanical and Satisfaction Analysis of 3D Printed Comfort Insoles

University of Pecs1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Tóth

Head of Biomechanical Laboratory M.D. PhD.

University of Pecs

研究点 (1)

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