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.

项目摘要 人的手在执行许多日常活动中起着至关重要的作用，包括自喂养，工具使用和 娱乐。因此，由于创伤或疾病而导致的手的丧失可以显着限制或干扰 肢体损失的人进行日常活动和工作的能力，从而极大地影响了整体质量 生活。尽管假肢设计和研究取得了进步 剩下上肢损失的人的假肢手仍然存在，包括有限的日常活动能力和 假肢的耐用性差。因此，今天的商业上可用的肌电伪造 无法满足肢体损失的人的需求，即重新获得一定程度的自治，功能和 重新进入劳动力。为了解决这些差距，在过去的几年中，我们调查了 人造拟人手最初是为机器人抓握和操纵而设计的 - 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的假肢之手 人类手协同和软机器人技术的概念。初步功能的结果 评估和生物力学分析表明，上肢损失的个体可以执行 SHP的掌握和操纵任务的各种级别相似或优于其偏好的级别 假体装置。此外，主题调查还报告了有关宽松和舒适性的积极反馈 与使用SHP有关。该反馈也有助于制作软件和硬件 改进，使手更轻，能够掌握和操纵小物体。我们建议 确定SHP可以在多大程度上满足不属于跨性别截肢的三个关键需求 通过商业上可用的手提伪造：功能，多功能性和鲁棒性。我们将达到这个 目标通过将其功能，多功能性和鲁棒性与商业上可用的多位数进行比较 假肢，i-limb（ossur）。我们将追求三个目标：（1）确定多大程度上 使用SHP的抓握和操纵任务的执行优于I-LIMB，（2）确定 在很长一段时间内每天使用SHP和I-LIMB的范围可改善抓地力和 操纵性能，以及（3）获得SHP使用模式和受试者的满意度。 SHP和I-LIMB。我们将测试（1）SHP将优于I-LIMB的假设，以及（2）每日使用 在为期8周的时间里，这两个假肢的双手都将导致掌握的改善明显更大 SHP的操纵性能比I-LIMB。我们将获得收集的用法和调查数据 通过SHP和I-LIMB固件在日常使用过程中完成AIMS 1和2中获得的数据，以探索 日常使用。这项提出的工作很重要，因为它将深入了解创新的软协同作用 - 基于的假体设计允许商业假体中无法使用功能，多功能性和鲁棒性。