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临床试验/NCT03618628
NCT03618628已完成不适用

Carbon Fiber Off-Loading Orthosis

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年5月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Peak Plantar Pressure

研究概览

简要总结

The purpose of this study is to determine the ability of carbon fiber off loading orthoses to reduce plantar pressure while providing an augmented plantarflexor power to improve walking and function. Results of this study could lead to increased use of carbon fiber off loading orthoses for patients with diabetes, peripheral neuropathy, and foot wounds as a way augmenting wound healing and preventing future recurrences of wounds.

详细描述

The long term goal of this research is the successful incorporation of carbon fiber into an off loading device will provide protection to the insensate foot of people with diabetes by reducing localized peak pressures, and thus the risk of recurrence neuropathic foot wounds and fractures, while improving ankle power at push off that will allow individuals with loss of ankle muscle function to walk faster and return to dynamic activities required in their jobs and for full function in the community. The overall goal of this proposal is to determine effects of carbon fiber off loading orthoses (CFO) design characteristics (lay up and geometry of strut) on brace strength, weight, power return capacity, plantar off-loading and participant comfort using FE models, ex-vivo testing and human testing.

First, a CFO will be fabricated using geometry consistent with the current clinical standard. This representative CFO will serve as a baseline from which a finite element (FE) model will be built. The model will be altered as desired to determine the effects of variable design characteristics. The FE model will estimate brace deflection and stress when the CFO is designed with various lay up designs and brace thicknesses. We will use results from the FE model to fabricate a new CFO for study participants.

We will then measure peak plantar pressures during walking while the participants are barefoot, wearing the CFO consistent with current clinical standards, and wearing the new CFO fabricated based on the results of the FE model. We will also measure plantarflexor power during walking while the participants are wearing the CFO consistent with current clinical standards and while wearing the CFO designed based on the results of the FE model. It is believed that the FE model driven CFO design will lead to improved brace strength while reducing plantar pressure compared to barefoot and will have similar plantarflexor power as the CFO based on current clinical standards.

研究设计

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

入排标准

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

入选标准

  • Daily life includes a minimum of moderate activity level (variable cadence walking)
  • Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
  • Diagnosis of diabetes mellitus and peripheral neuropathy
  • Ability to ambulate in the community (K-level ≥ 2)
  • Age > 21 years

排除标准

  • Unable to ambulate and complete testing required for study participation.
  • Severe foot deformity of the hindfoot or any deformity of the foot with a dislocation resulting in a bony prominence on the plantar/weightbearing surface of the foot.
  • Neurological diseases that affects walking

结局指标

主要结局

Peak Plantar Pressure

时间窗: Participant was tested in new brace (based on FE model) after wearing for 1 week.

Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.

次要结局

未报告次要终点

研究者

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

Mary Hastings, PT, DPT, ATC

Professor of Physical Therapy, Orthopaedic Surgery

Washington University School of Medicine

研究点 (2)

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