Improving Footwear Options for Women and Men Veterans with Amputations

改善截肢男女退伍军人的鞋类选择

• 批准号: 10454895
• 负责人: Andrew H. Hansen
• 金额: --
• 依托单位: MINNEAPOLIS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10454895
• 关键词: American; Amputation; Ankle; Athletic; Biomimetics; Child; Clinical; Clothing; Custom; Development; Devices; Distal; Emotional; Environment; Event; Excision; Failure; Feedback; Female; Future; Gait; Goals; Heel; Height; Home; Human; Knowledge; Leg; Life; Mechanics; Modeling; Occupations; Persons; Phase; Process; Prosthesis; Psychologist; Rehabilitation therapy; Research Project Grants; Role; Safety; Self Perception; Shapes; Shoes; Societies; Sports; Surface; System; Techniques; Technology Transfer; Testing; Travel; Veterans; Walking; Width; Woman; Work; ankle prosthesis; design; digital; experience; foot; gait examination; home test; improved; innovation; limb loss; men; novel; prosthetic alignment; prosthetic foot; psychologic; rehabilitation technology; satisfaction; social; symposium

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.

该项目将开发一个新的假肢脚踝系统，使女退伍军人可以更轻松地在选择鞋（包括高跟鞋）之间进行更改，从而使妇女退伍军人在截肢后可以更完全重新融入自己的生活。拟议的系统也将对男女退伍军人有用，他们想在运动和其他活动（例如牛仔靴和运动鞋）之间更轻松地切换不同的脚跟高度的鞋类。最后，拟议的工作将与许多肢体损失的近200万美国人中的许多美国人有关（Ziegler-Graham等，2008），未来的定制脚的未来版本可能与截肢儿童高度相关。 绝大多数假肢是针对特定的脚跟高度鞋子对准的，如果用户决定穿着不同的脚跟高度的鞋类，则对聚集的稳定效果可能会稳定。尽管市场上有少数“脚跟高度可调”的脚，但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，从而限制了可以在鞋子内无动不稳的鞋子范围。此外，用户而不是由认证的假肢进行的不同鞋类的一致性更改，从而增加了次优路线的可能性。最后，没有商业可用的假肢可以适应不同宽度的鞋子，从而进一步限制了鞋类选择。为了最大程度地提高具有腿部截肢的男女退伍军人的参与和功能流动性，需要开发假肢/脚踝系统的发展，可以容纳潜水员的鞋类范围，并且用户可以轻松，快速地更改，同时保留临床上最佳的一致性。 该项目的目的是开发一种新的脚踝伪装系统，该系统将允许具有截肢的退伍军人选择具有脚跟高度在0-100mm（0-4英寸）之间的任何鞋类，并能够轻松地在这些鞋之间轻松切换，而无需更改其假言的对齐。假肢脚踝脚系统还将开发以覆盖22至28厘米之间的一系列尺寸（女性尺寸4.5-13.5或男性尺寸为3-12）。 使用ISO 10328标准的机械测试将用于确定脚踝脚系统的结构强度和耐用性。 ISO 10328标准包括静态证明，最终强度和耐用性测试，可进行200万个周期。机械测试期间的故障将为设计的变化提供信息，然后进行重复的机械测试。耐用性测试阈值300,000个周期将用于提示一个月的足够耐用性参加家庭测试（安全系数> 3）。 六名具有腿截肢的退伍军人（n = 3名女性和n = 3名男性）将在整个开发项目中参与，提供反馈，以改善设计并将新型系统与Eleantion®进行比较，Eleantion®是可调节的可调节鞋跟高度的英尺。在项目结束时，这些退伍军人的一个子集将将系统带回家一个月，每双鞋子的高跟鞋高度不同。在一个月的测试中，将每周与退伍军人联系，以获取现实世界中的反馈，这些反馈将用于改善设计。技术转移工作将在该项目期间开始，包括假肢公司参加的会议旅行。在项目的下半年还计划了传播。