A Music-Based Rehabilitation Device for Training and Assessing Hand Function

描述（由申请人提供）：手部损伤是一种常见的疾病，在美国和世界各地对残疾有很大的贡献。仅就中风而言，据估计，每年70万中风幸存者中有80%需要手部治疗。强化康复训练可减少长期手部损伤。不幸的是，在受伤后2周内，人们通常必须在没有专业帮助的情况下在家进行手部治疗。个人很少遵守家庭治疗的书面家庭计划。为了解决这个问题，我们开发了一种负担得起的（<100美元的制造成本）仪器手套，它要求用户练习功能性抓握动作来玩一个定制的电脑游戏，该游戏的灵感来自游戏历史上第三大最受欢迎的视频游戏《吉他英雄》。在一项针对9名中风患者的试点研究中，我们发现MusicGlove可以准确测量临床手部损伤水平，激励人们在40分钟的训练课程中进行1400多个练习抓握动作，并在临床上显著改善手部功能。当被问及他们有多大可能在家里完成这种治疗时，他们给它打了满分。为了将MusicGlove推向商业化，第一阶段项目的目标是：1）开发适合家庭康复（1-3个月）的MusicGlove原型。我们将修改我们的临床原型，使其能够承受数月的激烈家庭使用而不会损坏，具有直观、易于使用的游戏界面，适合对计算机经验最少的用户，并自动量化和记录用户的运动和使用习惯。2)对这个原型进行可用性研究，并根据用户反馈改进设计（2-3个月）。该反馈将从中风后手部受损的个体及其临床护理人员处获得。3)进行一项在家使用该器械的试点研究，将其性能与传统的在家自我监督治疗（4-6个月）进行比较。我们将招募10名慢性中风患者，让他们在家中使用该设备2个月; 10名对照组患者将接受小册子规定的标准家庭手部锻炼计划。我们假设，使用MusicGlove进行锻炼的个体a）比对照组更多地锻炼他们的手;和B）与对照组相比，他们的Box & Block评分提高了临床显著的量（6块）。该项目将产生一个工作和测试的原型，我们可以将其推向生产，并生成必要的用户体验数据，以继续改进产品，并在第二阶段进行更大规模的疗效试验。 公共卫生相关性：这项研究与公共卫生有关，因为它将增加上肢康复治疗的可及性并降低成本。这将为数百万患有中风和其他神经损伤后运动障碍的美国公民提供一条改善生活的途径。康复治疗不仅降低了毁灭性并发症的可能性，还提高了功能能力， 提高残疾人的生活水平，减轻残疾对社会造成的负担。

DESCRIPTION (provided by applicant): Hand impairment is a common condition that contributes substantially to disability in the U.S. and around the world. In the case of stroke alone, it is estimated that 80% of the 700,000 individuals who survive a stroke each year require hand therapy. Intensive rehabilitation exercise reduces long-term hand impairment. Unfortunately, as soon as 2 weeks after the onset of an injury, people often must perform hand therapy at home without professional assistance. Individuals rarely comply with written home programs for home therapy. To address this problem, we have developed an affordable (< $100 manufacturing cost) instrumented glove that requires the user to practice functional gripping movements to play a custom computer game inspired by the third most popular video game in gaming history, Guitar Hero. In a pilot study with 9 individuals with a stroke, we found that the MusicGlove accurately measures clinical hand impairment level, inspires people to make over 1400 practice grip movements in 40 minute training sessions, and induces clinically significant improvements in hand function. When asked how likely they would be to complete this therapy at home, they rated it a perfect 10 out 10. To move MusicGlove toward commercialization, the objectives of this Phase 1 project are to: 1) Develop a prototype of the MusicGlove suitable for at-home rehabilitation (months 1-3). We will modify our clinical prototype to withstand months of intense home use without breaking, to have an intuitive, easy-to-use game interface that is suitable for users who have minimal experience with computers, and to automatically quantify and log the user's movement and use habits. 2) Perform a usability study of this prototype and refine the design based on user feedback (months 2-3). This feedback will be obtained from individuals with hand impairment after stroke and their clinical caregivers. 3) Conduct a pilot study of at-home use of the device, comparing its performance to conventional at-home self-supervised therapy (months 4-6). We will recruit 10 individuals with a chronic stroke to use the device at home for 2 months; a control group of 10 individuals will receive a program of standard home hand exercises specified by a booklet. We hypothesize that the individuals who exercise with the MusicGlove will a) exercise their hand more than the control group; and b) improve their Box & Block score by a clinically significant amount (6 blocks), compared to the control group. This project will result in a working and tested prototype that we can push to production and generate the user experience data necessary to continue to improve the product and to move to a larger efficacy trial to be proposed in Phase II. PUBLIC HEALTH RELEVANCE: This research is relevant to public health because it will increase the accessibility and lower the costs of rehabilitation therapy for the upper extremity. This will provide a pathway to a better life for millions of U.S citizens suffering from motor impairment after stroke and other neurologic injuries. Not only does rehabilitation therapy reduce the likelihood of devastating complications, it also improves functional ability, increasing the standard of living of individuals with impairment and reducing the burden on society caused by disability.