The effect of personalised 3D printed metamaterial insoles in combination with a prefabricated offloading device for the reduction of plantar pressure in healthy individuals

Queensland University of Technology0 个研究点目标入组 14 人开始时间: 2024年9月25日最近更新: 2024年9月30日

适应症

试验速览

阶段: Unknown
状态: 尚未招募
发起方: Queensland University of Technology
入组人数: 14
主要终点: Peak plantar pressure[This will be assessed using the Novel Pedar X plantar pressure measurement system - This is a validated commercial system for measuring plantar pressure. This will be assessed using a validated 12 step protocol. Immediate effects following a brief acclimatisation period (at least 2 minutes) wearing the insole condition.]

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 No limit（—）
性别: All

入选标准

•Able to walk for 10 minutes without use of assistive devices (e.g. walking frame, walking stick).Available to attend a follow up appointment 2-4 weeks after the initial appointment.

排除标准

•Evidence of peripheral arterial disease.Loss of peripheral protective sensation.Current or history of previous foot ulceration, Charcot neuroarthropathy, previous amputation of foot (at any level).Previous amputation to lower limb.History of falls in previous 12 months.Current or recent (4 weeks) self-reported foot or leg pain.

结局指标

主要结局

Peak plantar pressure[This will be assessed using the Novel Pedar X plantar pressure measurement system - This is a validated commercial system for measuring plantar pressure. This will be assessed using a validated 12 step protocol. Immediate effects following a brief acclimatisation period (at least 2 minutes) wearing the insole condition.]

次要结局

未报告次要终点

研究者

发起方

Queensland University of Technology

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