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.

项目概要 微处理器控制的脚踝已被证明可以显着提高运动的灵活性和稳定性 下肢截肢的个人，但这些设备通常仅适用于行动能力较高的用户，因为 缺乏科学证据来证明保险报销的合理性。因此，许多体质较低的人 最需要先进技术的肢体截肢却无法实现。 该第一阶段申请描述了一种微处理器控制的踝关节假肢，适用于患有低血压的个体。 肢体截肢可无缝适应不同的活动和地形，包括斜坡行走和站立， 楼梯行走和高度不平坦的地形行走。由于这种调整，该设备是预期的，并且已经 前期工作已表明，可以提高这些地形的安全性、稳定性和舒适度。 第一阶段提案的主要目标是对拟议项目的价值进行初步评估 为行动不便的下肢截肢者安装假肢。这些证据对于证明保险的合理性至关重要 因此，这是将微处理器技术带给个人的过程中至关重要的一步 K2 移动级别。为此，研究人员提出以下目标：1）使所提出的脚踝适应 优化下肢截肢的 K2 个体的表现，并且 2) 进行试点研究 (n=5) 来量化 与谓词非 MPC 脚踝相比，所提出的脚踝在提高性能方面的有效性 适用于下肢截肢的 K2 个体。