Design and Evaluation of a High-Performance, Low-Cost Prosthetic Foot for Developing Countries

IF 0.8 4区 医学 Q4 ENGINEERING, BIOMEDICAL Journal of Medical Devices-Transactions of the Asme Pub Date : 2022-10-13 DOI:10.1115/1.4055967
W. Johnson, Victor Prost, Pooja Mukul, A. Winter
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Abstract

A novel, high-performance, cosmetic, rugged, appropriately-costed, mass-manufacturable prosthetic foot for use in low-income countries was designed and field tested. This ruggedized foot was created to accommodate the unique economic, environmental, and cultural requirements for users in India. A previous prototype that enabled able-bodied like gait was modified to include a durable cosmetic cover without altering the tuned stiffness of the overall foot. After undergoing mechanical benchtop testing, the foot was distributed to prosthesis users in India to for at least 5 months. Afterwards, participants underwent clinical tests to evaluate walking performance, and additional benchtop testing was performed on the field-tested feet to identify changes in performance. The ruggedized foot endured one million fatigue cycles without failure and demonstrated the desired stiffness properties. Subjects walked significantly faster (0.14 m/s) with the ruggedized foot compared to the Jaipur foot, and the feet showed no visible sign of damage after months of use. Additionally, the field-tested feet showed little difference in stiffness from a set of unused controls. Anecdotal feedback from the participants indicated that the foot improved their speed and/or walking effort, but may benefit from more degrees of freedom about the ankle. The results suggest that the foot fulfills its design requirements; however, further field testing is required with more participants over a longer period to make sure the foot is suitable for use in developing countries.
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一种适用于发展中国家的高性能、低成本假肢足的设计与评价
为低收入国家设计了一种新型、高性能、美观、坚固、成本合理、可大规模生产的假肢足,并进行了现场测试。这种坚固耐用的脚是为了适应印度用户独特的经济、环境和文化要求而设计的。先前的原型,使健全的步态被修改,包括一个耐用的化妆品覆盖,而不改变整个脚的调整刚度。经过机械台式测试后,脚被分发给印度的假体用户至少5个月。之后,参与者进行临床测试以评估步行性能,并对现场测试的脚进行额外的台式测试以确定性能的变化。加固后的脚经受了100万次疲劳循环而没有失效,并显示出所需的刚度特性。与斋浦尔足相比,受试者用加固足行走的速度明显更快(0.14 m/s),并且在使用数月后,足部没有明显的损伤迹象。此外,现场测试的脚与一组未使用的控制脚的刚度几乎没有区别。来自参与者的轶事反馈表明,脚提高了他们的速度和/或行走的努力,但可能受益于踝关节的更多自由度。结果表明,该脚满足设计要求;然而,需要更多的参与者在更长的时间内进行进一步的实地测试,以确保这种脚适合在发展中国家使用。
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来源期刊
CiteScore
1.80
自引率
11.10%
发文量
56
审稿时长
6-12 weeks
期刊介绍: The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.
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