Improving Footwear Options for Women and Men Veterans with Amputations

该项目将开发一种新的假肢踝足系统，使女性退伍军人能够更容易地更换她们选择的鞋子，包括高跟鞋，使女性退伍军人能够在截肢后更充分地重新融入她们的生活。所提出的系统也将对女性和男性退伍军人有用，他们希望更容易地在不同鞋跟高度的鞋类之间切换以进行运动和其他活动（例如，牛仔靴和运动鞋）。最后，拟议的工作将与近200万患有肢体缺失的美国人中的许多人相关（Ziegler-Graham等人，2008），未来版本的定制脚可能与截肢儿童高度相关。 绝大多数假脚都是针对特定鞋跟高度的鞋而对齐的，如果使用者决定穿具有不同鞋跟高度的鞋，则可能对步态产生不稳定影响。虽然市场上有少量的“脚跟高度可调节”的脚，但是这些脚的足底表面的形状不会改变以匹配不同鞋类的内部，限制了可以使用的鞋的范围，而不会使脚在鞋内不稳定。此外，不同鞋类的对准变化由用户而不是由认证的假肢师执行，增加了次优对准的可能性。最后，没有可商购的假脚可以适应不同宽度的鞋，进一步限制了鞋类的选择。为了最大化腿部截肢的女性和男性退伍军人的参与和功能移动性，非常需要开发一种假足/踝系统，该假足/踝系统可以适应各种各样的鞋类，并且可以由使用者容易且快速地更换，同时保持由假肢专家确定的临床最佳对准。 该项目的目的是开发一种新的踝足假肢系统，使截肢的退伍军人能够选择鞋跟高度在0- 100 mm（0-4英寸）之间的任何鞋子，并且能够在这些鞋子之间轻松切换，而无需改变假肢的对齐方式。还将开发踝足假肢系统，以涵盖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）。 采用ISO 10328标准进行的机械测试将用于确定踝足系统的结构强度和耐久性。ISO 10328标准包括防静电、极限强度和200万次循环的耐久性测试。机械测试期间的失效将通知设计变更，然后进行重复机械测试。将使用300，000次循环的耐久性测试阈值来表明一个月的带回家测试具有足够的耐久性（安全系数> 3）。 六名截肢退伍军人（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，并将新型系统与Elation®（一种市售可调节脚跟高度的脚）进行比较。在项目结束时，这些退伍军人中的一部分人将把系统带回家一个月，每人使用三双不同鞋跟高度的鞋子。在为期一个月的测试期间，将每周联系退伍军人，以获得来自实际使用的反馈，这些反馈将用于改进设计。技术转让工作将在该项目期间开始，包括前往参加假肢公司参加的会议。还计划在项目的后半期进行宣传。

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.