Assessment of a Microprocessor Ankle for Low Mobility Individuals with Amputation

微处理器踝关节对低活动能力截肢患者的评估

• 批准号: 10591094
• 负责人: Brian Edward Lawson
• 金额: $ 27.66万
• 依托单位: SYNCHRO MOTION, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10591094
• 关键词: Adoption; Advocate; Amputation; Amputees; Ankle; Awareness; Biomechanics; Bionics; Chicago; Clinical; Clinical Data; Data; Devices; Effectiveness; Funding; Gait; Goals; Guidelines; Healthcare Common Procedure Coding System; Individual; Industry; Insurance; Insurance Carriers; Intervention; Investigation; Joints; Kinetics; Knowledge; Laboratories; Lower Extremity; Measures; Medicare; Medicine; Microprocessor; Motion; Names; Outcome; Outcome Measure; Pathology; Pathway interactions; Patient Outcomes Assessments; Patients; Performance; Phase; Pilot Projects; Plant Roots; Population; Privatization; Process; Prosthesis; Ramp; Recommendation; Rehabilitation therapy; Reporting; Research; Research Personnel; Safety; Series; Small Business Technology Transfer Research; Technology; Testing; United States Centers for Medicare and Medicaid Services; Variant; Walking; Weight-Bearing state; Work; ankle prosthesis; clinically relevant; design; experience; improved; improved mobility; improved outcome; interest; kinematics; limb amputation; novel; pressure; virtual

PROJECT SUMMARY Microprocessor-controlled ankles have been shown to substantially improve mobility and stability in individuals with lower limb amputation, but these devices are typically only available to higher mobility users due to a lack of scientific evidence to justify insurance reimbursement. As such, many of the individuals with lower limb amputation that have the greatest need for advanced technology are unable to attain it. This Phase I application describes a microprocessor-controlled ankle prosthesis for individuals with lower- limb amputation that adapts seamlessly to varying activities and terrain, including slope walking and standing, stair walking, and highly-uneven terrain walking. As a result of this adaptation, the device is expected, and has been shown in preliminary work, to improve safety and enhance stability and comfort across these terrains. The primary goal of this Phase I proposal is to conduct a preliminary assessment of the value of the proposed prosthesis on lower mobility individuals with lower limb amputation. Such evidence is critical to justify insurance reimbursement, and so it is a vital step in the process of bringing microprocessor technology to individuals at the K2 mobility level. In order to do so, the investigators propose the following aims: 1) adapt the proposed ankle to optimize performance for K2 individuals with lower limb amputation, and 2) perform a pilot study (n=5) to quantify the effectiveness of the proposed ankle as compared to a predicate non-MPC ankle in improving performance for K2 individuals with lower limb amputation.

项目摘要 微处理器控制的脚踝已显示可大大提高迁移率和稳定性 下肢截肢的人，但是这些设备通常仅适用于更高的移动性用户 缺乏科学证据来证明保险报销是合理的。因此，许多人较低 对先进技术最需要的肢体截肢无法实现。 该阶段I应用描述了一个微处理器控制的脚踝假体，适用于较低的人 肢体截肢无缝地适应各种活动和地形，包括步行和站立， 楼梯步行和高度的地形步行。由于这种适应性，该设备是可以预期的，并且具有 在初步工作中展示了，以提高安全性并提高这些地形的稳定性和舒适性。 该阶段I建议的主要目标是对提议的价值进行初步评估 下肢截肢较低的流动性个体的假体。这种证据对于证明保险是至关重要的 报销，因此，这是将微处理器技术带给个人的至关重要的一步 K2流动性水平。为此，调查人员提出以下目的：1）将提议的脚踝适应 优化下肢截肢的K2个体的性能，以及2）进行试验研究（n = 5）以量化 与谓词非MPC脚踝相比，提出的脚踝的有效性在提高性能方面 对于具有下肢截肢的K2个体。