Pivot-Flex Foot

枢轴弯曲脚

• 批准号: 10424359
• 负责人: Glenn Klute
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10424359
• 关键词: Acclimatization; Adoption; American; Amputees; Ankle; Biomechanics; Blinded; Clinical Trials; Communities; Complex; Computers; Conflict (Psychology); Coupled; Couples; Coupling; Development; Devices; Diabetes Mellitus; Disease; Etiology; Face; Future; Gait; Height; Hip Joint; Hip region structure; Human; Incidence; Individual; Industry Standard; Injury; Joints; Knee; Laboratories; Limb Prosthesis; Limb structure; Lower Extremity; Measures; Motion; Motor; Operative Surgical Procedures; Outcome; Participant; Play; Population; Prosthesis; Research; Research Support; Role; Rotation; Sampling; Soft Tissue Injuries; Technology; Test Result; Testing; To specify; Torque; Torsion; Veterans; Walking; Weight; Work; base; clinically relevant; commercialization; cost; design; disability; experimental study; foot; human subject; innovation; limb amputation; limb loss; military veteran; novel; prosthetic foot; residual limb; satisfaction; soft tissue; standard of care; stem

Project Summary (Public Abstract) When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available. While these conventional prosthetic feet primarily function in the sagittal plane, the intact foot and ankle comprise a complex set of joints that allow rotation in multiple planes of motion. Some of these motions are coupled, meaning rotation in one plane induces motion in another. One such coupling is between the sagittal and transverse planes. For every step, plantar- and dorsi-flexion motion is coupled with external and internal rotation of the shank relative to the foot, respectively. There is no prosthetic foot available for prescription that mimics this natural coupling. The purpose of the proposed research is to develop a passive prosthesis (Pivot-Flex Foot) that mimics the natural coupling of the intact limb and determine if this coupling can reduce transverse-plane socket torque and compensatory gait biomechanics when compared to a standard-of-care prosthesis. We anticipate the long-term outcomes from wearing a Pivot-Flex Foot are a lower incidence of soft tissue and compensatory gait injuries. To investigate the need for this coupling, we have already built a torsionally adaptive prosthesis (TAP) where the coupling ratio between the transverse- and sagittal-planes can be independently controlled with a motor. The TAP can be used to discover the optimal coupling ratio, but is a bit unwieldy for long-term, everyday use. A more robust solution for daily wear is the Pivot-Flex Foot, a passive prosthesis we have built using industry standards. We plan to use the TAP to identify the optimal coupling ratio and then build a selection of Pivot-Flex Feet for testing by individuals with lower limb amputation. Our proposed research has two specific aims: (1) To identify the optimal coupling ratio between transverse- and sagittal-plane motions using a novel, torsionally adaptive prosthesis. We propose to conduct a human subject experiment (n=15) with below-knee amputees wearing the motor-driven and computer controlled TAP. Participants will walk in a straight line and in both directions around a circle while we vary the coupling ratio between transverse- and sagittal-plane motions. Participants will be blinded to the coupling ratio. We hypothesize that: (1) a coupling ratio exists that minimizes undesirable transverse-plane socket torque and (2) there will be a coupling ratio that amputees prefer. The results from this test will be used to specify the coupling ratio of the more practical Pivot- Flex Feet we plan to test in specific aim 2. (2) To determine if a passive prosthesis with an optimal coupling ratio (Pivot-Flex Foot) can reduce transverse-plane socket torque and compensatory gait biomechanics when compared to a standard-of-care prosthesis. We propose to design and build Pivot-Flex Feet of various sizes and stiffnesses that can be worn by a majority of below-knee amputees. In a blinded crossover experiment, participants (n=15) will be fit with the Pivot-Flex Foot and the Össur Vari-Flex XC Rotate prostheses (random order), and then wear each for two weeks before we test them. The tests will involve walking in a straight line and in both directions around a circle while we measure their gait biomechanics. We hypothesize that the Pivot- Flex Foot will reduce transverse-plane socket torque and the work performed by the hip when compared to a standard-of-care prosthesis. After the proposed project, we will have evidence regarding the need for providing coupled motion in a lower limb prosthesis. If the Pivot-Flex Foot proves efficacious in this laboratory-based study, we will investigate long- term outcomes, namely reduced incidence of soft tissue and compensatory gait injuries, and pursue commercial development.

项目摘要（公共摘要） 开处方假肢时，临床医生面临着令人眼花show乱的选择 尽管这些常规的假肢可以使用。 完整的脚和踝关节组成了一组复杂的接头，可以在多个运动平面中旋转。其中一些 这些运动是耦合的，这意味着一个平面的旋转会影响另一个平面的运动。一个这样的耦合是 在矢状和横向平面之间。对于每一步 小腿相对于脚的外部和内部旋转。没有假肢可用 为了模仿这种自然耦合的处方。 拟议的研究的目的是开发一个被动假体（Pivot-Flex脚），以模仿自然 完整肢体的耦合，并确定此耦合是否可以减少横平插座扭矩和 与护理标准假体相比，补偿步态生物力学。我们期待长期 佩戴枢轴脚的脚的结果是软组织和补偿性AIT损伤的较低事件。 为了调查这种耦合的需求，我们已经建立了一个自适应假体（TAP） 横向平面和矢状平面之间的耦合比可以通过电动机独立控制。这 TAP可用于发现最佳耦合率，但每天使用的长期使用有点笨拙。更多 日常磨损的强大解决方案是Pivot-Flex脚，这是我们使用行业标准建造的被动假体。 我们计划使用水龙头来识别最佳耦合率，然后为 下肢截肢的个体测试。 我们提出的研究有两个具体的目标： （1）使用A横向和矢状平面运动之间的最佳耦合比 小说，扭转自适应假体。我们建议与 膝盖下的截肢者穿着电动机驱动和计算机控制的水龙头。参与者将走进 直线和两个方向围绕一个圆的两个方向，而我们改变横向和之间的耦合比 矢状平面运动。参与者将对耦合比率视而不见。我们假设：（1）耦合比 存在可以最大程度地减少难以透明的横向平面插座扭矩，（2）将有一个耦合比 截肢者更喜欢。该测试的结果将用于指定更实际的枢轴的耦合比 弯曲脚我们计划在特定的目标2中测试。 （2）确定具有最佳耦合比（Pivot-Flex脚）的被动假体是否可以 与相比 护理标准假体。我们建议设计和建造各种尺寸的Pivot-Flex英尺， 大多数膝盖截肢者都可以佩戴的刚度。在盲人的跨界实验中 参与者（n = 15）将适合枢轴 - 弗利脚和Össurvari-flex XC旋转假体（随机 订购），然后在我们测试之前佩戴两个星期。测试将涉及直线行走 在我们测量步​​态生物力学的同时，在两个方向上都有两个方向。我们假设枢轴 - 弯曲脚将减少横向平面插座扭矩，并且与A相比 护理标准假体。 在拟议的项目之后，我们将有证据表明需要在较低的情况下提供耦合运动 肢体假体。如果在这项基于实验室的研究中证明了Pivot-Flex脚有效，我们将研究长期 术语结果，即减少软组织的事件和补偿性辅助损伤以及购买商业 发展。