Toward use of the synergy-based SoftHand Pro for activities of daily living by transradial amputees: A multi-site clinical trial

针对经桡动脉截肢者使用基于协同作用的 SoftHand Pro 进行日常生活活动：一项多中心临床试验

• 批准号: 10684785
• 负责人: MARCO SANTELLO
• 金额: $ 62.02万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-12 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684785
• 关键词: Activities of Daily Living; Address; Adult; Affect; Amputation; Arizona; Clinic; Clinical Trials; Collaborations; Complement; Computer software; Crossover Design; Data; Digit structure; Disease; Disparity; Electromyography; Endowment; Feedback; Forearm; Genetic Complementation Test; Grant; Hand; Home; Human; Individual; Joints; Laboratories; Limb Prosthesis; Limb structure; Literature; Mechanics; Modification; Motor; Multi-Institutional Clinical Trial; Muscle; Myoelectric prosthesis; Outcome Measure; Participant; Pattern; Performance; Persons; Play; Prosthesis; Prosthesis Design; Quality of life; Randomized; Recreation; Reporting; Research; Research Personnel; Robotics; Role; Shapes; Site; Surveys; Technology; Testing; Time; Traumatic injury; United States National Institutes of Health; Universities; Upper Extremity; Weight; Work; battery life; biomechanical test; design; feeding; grasp; improved; innovation; insight; kinematics; limb loss; new technology; novel; performance tests; primary outcome; prosthetic hand; prototype; response; satisfaction; secondary analysis; secondary outcome; synergism; tool; transradial amputee

PROJECT SUMMARY The human hand plays a critical role in performing many daily activities including self-feeding, tool use, and recreation. Therefore, loss of the hand due to traumatic injury or disease can significantly limit or interfere with the ability of persons with limb loss to perform daily activities and work, thus greatly affecting overall quality of life. Despite advances in prosthetic hand design and research, several barriers to widespread acceptance of prosthetic hands by persons with upper limb loss remain, including limited ability to perform daily activities and poor durability of the prosthetic hand. Therefore, today’s commercially-available myoelectric hand prostheses fail to address the needs of persons with limb loss, i.e., regaining some degree of autonomy, functionality, and re-entry into the work force. To address these gaps, in the past few years we have investigated the extent to which an artificial anthropomorphic hand originally designed for robotic grasping and manipulation – the SoftHand – could be used for prosthetic applications through a non-invasive myoelectric controller – the SoftHand Pro (SHP). The novel design of the SHP is the only prosthetic hand in the world that combines the concept of human hand synergies and soft robotics technologies. The results of preliminary functional assessments and biomechanical analyses revealed that individuals with upper limb loss could perform a variety of grasping and manipulation tasks with the SHP at levels similar or superior to those of their preferred prosthetic device. Additionally, subject surveys reported positive feedback about the ease and comfort associated with using the SHP. This feedback was also instrumental in making software and hardware improvements to make the hand lighter and able to grasp and manipulate small objects. We propose to determine the extent to which the SHP can address three critical needs of transradial amputees that are not met by commercially-available hand prostheses: function, versatility, and robustness. We will attain this objective by comparing its function, versatility, and robustness with a commercially-available multi-digit prosthetic hand, the i-limb (Ossur). We will pursue three aims: (1) to determine the extent to which performance of grasping and manipulation tasks using the SHP is superior to the i-limb, (2) to determine the extent to which daily use of the SHP and i-limb over an extended period of time improves grasping and manipulation performance, and (3) to obtain SHP usage patterns and subjects’ satisfaction ratings from using the SHP and i-limb. We will test the hypotheses that (1) the SHP will outperform the i-limb, and (2) daily use of both prosthetic hands over an 8-week period each will lead to significantly greater improvement in grasping and manipulation performance with the SHP than the i-limb. We will obtain usage and survey data collected through the SHP and i-limb firmware during daily use to complement data obtained in Aims 1 and 2 to explore daily use. This proposed work is significant because it will shed insight on whether an innovative soft synergy- based prosthetic design allows for function, versatility and robustness not available in commercial prostheses.

项目概要 人手在许多日常活动中发挥着至关重要的作用，包括自我进食、工具使用和 因此，由于外伤或疾病而失去手会严重限制或干扰休闲活动。 肢体丧失者进行日常活动和工作的能力，从而极大地影响其整体素质 尽管假手设计和研究取得了进步，但广泛接受仍存在一些障碍。 上肢丧失者仍保留假手，包括进行日常活动的能力有限和 因此，目前市售的肌电假手的耐用性较差。 未能满足肢体丧失者的需求，即恢复一定程度的自主权、功能和 为了解决这些差距，我们在过去几年中调查了重新进入劳动力市场的程度。 这是一种拟人化的人工手，最初是为机器人抓取和操作而设计的—— SoftHand – 可通过非侵入性肌电控制器用于假肢应用 – SoftHand Pro (SHP) 的新颖设计是世界上唯一结合了 人手协同概念和软机器人技术的初步功能结果。 评估和生物力学分析表明，上肢丧失的个体可以执行 使用 SHP 完成各种抓取和操作任务，其水平与他们喜欢的水平相似或更高 此外，受试者调查报告了关于假肢装置的易用性和舒适性的积极反馈。 与使用 SHP 相关的反馈对于制作软件和硬件也很有帮助。 我们建议进行改进，使手变得更轻，能够抓住和操纵小物体。 确定 SHP 能够在多大程度上满足经桡动脉截肢者的三个关键需求 商用手动工具能够满足以下要求：功能、多功能性和坚固性，我们将实现这一点。 通过将其功能、多功能性和鲁棒性与市售多位数进行比较来确定目标 假手，i-limb（Ossur）我们将追求三个目标：（1）确定其程度。 使用 SHP 执行抓取和操作任务的性能优于 i-limb，(2) 确定 长期日常使用 SHP 和 i-limb 在多大程度上改善了抓握和 操纵性能，以及（3）获得小水电的使用模式和受试者对使用的满意度 我们将测试以下假设：(1) SHP 将优于 i-limb，以及 (2) 日常使用。 两只假手在 8 周的时间内都会显着改善抓握能力 SHP 的操控性能优于 i-limb 我们将获得收集的使用情况和调查数据。 在日常使用过程中通过SHP和i-limb固件来补充Aims 1和2中获得的数据进行探索 这项拟议的工作意义重大，因为它将深入了解创新的软协同作用是否如此。 基于假肢设计的功能、多功能性和坚固性是商业假肢所不具备的。