Improving Footwear Options for Women and Men Veterans with Amputations

该项目将开发一种新的假肢脚踝-脚系统，使女退伍军人能够更容易地在他们选择的鞋子之间进行切换，包括高跟鞋，使女退伍军人在截肢后更完全地重新融入他们的生活。拟议的制度也将有助于男女退伍军人，他们希望更容易地在运动和其他活动(例如牛仔靴和运动鞋)的不同鞋跟高度之间切换。最后，拟议的工作将与近200万失去肢体的美国人中的许多人相关(Ziegler-Graham等人，2008年)，未来版本的定制足可能与截肢儿童高度相关。 绝大多数的假脚都是对齐特定鞋跟高度的鞋子，如果使用者决定穿不同鞋跟高度的鞋子，可能会对步态产生不稳定的影响。虽然市面上有一小部分脚跟高度可调的脚，但这些脚的足底表面的形状并没有改变，以匹配不同鞋类的内部，限制了鞋内可以使用的鞋的范围，而不会出现脚的不稳定。此外，不同鞋子的对齐改变是由用户而不是由认证的假肢医生执行的，这增加了出现次优对齐的可能性。最后，市场上还没有能适应不同宽度鞋子的假肢，这进一步限制了鞋类的选择。为了最大限度地提高接受腿部截肢的女性和男性退伍军人的参与度和功能活动度，非常需要开发一种假肢/踝关节系统，该系统可以容纳不同范围的鞋类，并且可以由使用者容易和快速地更换，同时保持假肢医生确定的临床最佳对齐方式。 该项目的目的是开发一种新的脚踝-脚假体系统，允许截肢退伍军人选择鞋跟高度在0-100 mm(0-4英寸)之间的任何鞋子，并能够在这些鞋子之间轻松切换，而不需要改变假体的对齐方式。假肢踝足系统也将被开发成覆盖22至28厘米的尺寸范围(女性尺寸为4.5至13.5或男性尺寸为3至12)。 使用国际标准化组织10328标准的机械测试将用于确定脚踝-足部系统的结构强度和耐久性。国际标准化组织10328标准包括静力验证、极限强度和耐久性测试，可达到200万次循环。机械测试期间的失败将通知设计中的更改，随后是重复的机械测试。耐久性测试阈值为300,000次将被用来建议足够的耐用性进行一个月的带回家测试(安全系数&gt；3)。 六名腿部截肢的退伍军人(N=3名女性和N=3名男性)将参与整个开发项目，提供反馈以改进设计，并将新系统与商业上可获得的脚跟高度可调的Elation®进行比较。在项目结束时，这些退伍军人中的一部分将把系统带回家一个月，每个人都会选择三双不同鞋跟高度的鞋子。在为期一个月的测试期间，退伍军人每周都会被联系，从现实世界的使用中获得反馈，这些反馈将被用来改进设计。技术转让工作将在该项目期间开始，包括前往假肢公司参加的会议。还计划在项目的后半部分进行传播。

This project will develop a new prosthetic ankle-foot system that allows Women Veterans to more easily change between their footwear of choice, including high heel shoes, allowing Women Veterans to more fully reintegrate into their lives after amputation. The proposed system will also be useful for Women and Men Veterans who would like to more easily switch between footwear of different heel heights for sports and other activities (e.g., cowboy boots and athletic shoes). Lastly, the proposed work will be relevant to many of the nearly 2 million Americans living with limb loss (Ziegler-Graham et al, 2008), with future versions of customized feet potentially being highly relevant for children with amputations. The vast majority of prosthetic feet are aligned for a specific heel height shoe, with a potentially de-stabilizing effect on gait if the user decides to wear footwear with different heel heights. Although there are a small number of “heel-height adjustable” feet on the market, the shapes of the plantar surfaces of these feet do not change to match the interior of different footwear, restricting the range of shoes that can be used without instability of the foot within the shoe. Additionally, alignment changes for different footwear are performed by the user rather than by a certified prosthetist, increasing the likelihood of sub-optimal alignment. Lastly, there are no commercially available prosthetic feet that can adjust to shoes of different widths, further limiting footwear options. In order to maximize the participation and functional mobility of Women and Men Veterans with leg amputations, there is a great need for the development of a prosthetic foot/ankle system that could accommodate a diverse range of footwear and could be changed easily and quickly by the user while retaining the clinically optimal alignment determined by the prosthetist. The purpose of this project is to develop a new ankle-foot prosthesis system that will allow Veterans with amputations to choose any footwear with heel heights between 0-100mm (0-4 inches), and to be able to easily switch between these footwear without needing to change the alignment of their prosthesis. Prosthetic ankle-foot systems will also be developed to cover a range of sizes between 22 and 28 cm (women’s sizes 4.5-13.5 or men’s sizes 3-12). Mechanical testing using the ISO 10328 standard will be used to determine structural strength and durability of the ankle-foot system. The ISO 10328 standard includes static proof, ultimate strength, and durability testing to 2 million cycles. Failures during mechanical testing will inform changes in the design, followed by repeated mechanical testing. A durability testing threshold of 300,000 cycles will be used to suggest sufficient durability for a one month take home test (safety factor > 3). Six Veterans with leg amputations (N=3 women and N=3 men) will participate throughout the development project, providing feedback to improve the design and comparing the novel system to the Elation®, a commercially-available adjustable heel-height foot. At the end of the project, a subset of these Veterans will take the system home for one month, each using three pairs of shoes with different heel heights of their choice. During the one month testing, Veterans will be contacted weekly to obtain feedback from real-world usage, which will be used to improve the design. Technology transfer efforts will begin during this project, including travel to conferences attended by prosthetics companies. Dissemination is also planned during the second half of the project.