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: 10212104
• 负责人: MARCO SANTELLO
• 金额: $ 63.78万
• 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/10212104
• 关键词: Activities of Daily Living; Address; Adult; Affect; Amputation; Arizona; Biomechanics; Clinic; Clinical Trials; Complement; Computer software; Crossover Design; Data; Digit structure; Disease; Feedback; Fibrinogen; Forearm; Grant; Hand; Home; Human; Individual; Joints; Laboratories; Life; 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; Rogaine; Role; Shapes; Site; Surveys; Technology; Testing; Time; Traumatic injury; United States National Institutes of Health; Universities; Upper Extremity; Weight; Work; base; 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.

项目摘要 人类的手在执行许多日常活动中起着关键作用，包括自我喂食，工具使用， 娱乐因此，由于创伤性损伤或疾病导致的手的丧失可以显著地限制或干扰手的功能。 肢体丧失的人进行日常活动和工作的能力，从而大大影响 生活尽管假手设计和研究取得了进展，但广泛接受假手的几个障碍仍然存在。 上肢丧失者的假手仍然存在，包括进行日常活动的能力有限， 假手的耐用性差。因此，目前市售的肌电假手 未能满足肢体丧失者的需求，即，重新获得一定程度的自主性、功能性， 重新进入劳动力市场。为了解决这些差距，在过去几年中，我们调查了 这是一只人造拟人手，最初是为机器人抓取和操纵而设计的-- SoftHand -可通过非侵入性肌电控制器用于假肢应用- SoftHand Pro（SHP）. SHP的新颖设计是世界上唯一一个结合了 人机协同概念和软机器人技术。初步功能测试结果 评估和生物力学分析显示，上肢丧失的人可以进行 各种抓握和操作任务，SHP水平与他们的首选水平相似或上级 假肢装置此外，受试者调查报告了关于易用性和舒适性的积极反馈 与使用SHP有关。这种反馈也有助于制造软件和硬件 改进，使手更轻，能够抓住和操纵小物体。我们建议 确定SHP可以满足经桡动脉截肢者的三个关键需求的程度， 满足商业上可用的手假体：功能，多功能性和鲁棒性。我们会做到的 目的通过比较其功能，多功能性和鲁棒性与市售的多位 假肢手，i-limb（Ossur）。我们将追求三个目标：（1）确定在多大程度上 使用SHP的抓握和操作任务的性能上级i-肢，（2）确定 在较长时间内每天使用SHP和i-limb改善抓握的程度， 操作性能，以及（3）获得SHP使用模式和受试者的满意度评级，从使用 SHP和i-limb。我们将测试以下假设：（1）SHP的性能优于i-limb，以及（2）日常使用 两个假手在8周的时间内，每个假手在抓握方面都会有明显的改善 和操作性能与SHP比i-肢体。我们将获取收集的使用和调查数据 在日常使用过程中通过SHP和i-limb固件补充目标1和2中获得的数据，以探索 日常使用。这项拟议的工作是重要的，因为它将揭示一个创新的软协同作用是否- 基于的假体设计允许商业假体中不可用的功能、多功能性和坚固性。