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

在美国，手部损伤是一种常见的疾病， 世界各地仅就中风而言，据估计，70万人中有80% 每年中风后幸存的人都需要手部治疗。密集的康复锻炼减少 长期手部损伤不幸的是，在受伤后两周， 经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MusicGlove，这是一种价格实惠的仪器手套，需要使用者练习 功能性的抓握动作，以发挥自定义的电脑游戏的灵感来自第三个最受欢迎的 游戏史上最伟大的电子游戏吉他英雄在我们对16名中风患者的I期研究中， 在家里使用该设备的人，以及早期的一项针对9名中风患者的试点研究， 在临床上使用该设备时，我们发现MusicGlove可以准确地测量临床手部 损伤水平，激励人们在40分钟的训练中进行1400多个练习握杆动作 会话，并刺激显着更大的改善手功能比传统的 疗法我们第二阶段的目标是：1）开发一个适合于以下情况的MusicGlove生产模型： 商业化（1-12个月）。我们将修改我们的功能原型，使其更健壮，更易于使用， 并以符合FDA标准的方式有效制造，并将完成 直观、易于使用的游戏界面，可自动量化和记录用户的运动 使用习惯。我们还将开发下一代技术，以改进未来的模型。（二） 在亚急性卒中患者中进行该器械的双中心随机对照试验（月 12-24）。亚急性卒中患者是一个巨大的潜在用户群体。在两个地点，我们将 将44名亚急性卒中患者随机分组，接受MusicGlove的额外治疗 或额外的常规治疗四周。我们假设那些 使用MusicGlove进行锻炼将显著提高他们的Box & Block评分 （6块），与对照组相比。3)对器械的使用进行初步研究， 患有慢性、颈部、不完全SCI的患者（12-24个月）。我们还将建立初步的 SCI患者（n = 20）的安全性、可行性和有效性，另一个重要的用户组4） 征求关于器械在正常临床实践中可用性的反馈（12-24个月）。我们将 将MusicGlove分发给三个领先的康复单位，并研究这些单位如何 将该设备纳入患者护理中。第二阶段项目将在商业上- 我们将生产和销售的现成的临床验证产品。

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 the MusicGlove, an affordable 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 our Phase I study with 16 individuals with a stroke who used the device at home, and an earlier pilot study with 9 individuals with a stroke who used the device in the clinic, 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 stimulates significantly greater improvements in hand function than conventional therapy. Our aims for Phase II are to: 1) Develop a production model of the MusicGlove suitable for commercialization (months 1-12). We will modify our functional prototype to be robust, easy to use, and efficiently manufactured in an FDA-compliant way, and will complete development of an intuitive, easy-to-use game interface that automatically quantifies and logs the user's movement and use habits. We will also develop next generation technologies for improved future models. 2) Perform a two-site randomized controlled trial of the device with sub-acute stroke patients (months 12-24). Individuals with subacute stroke are a large potential user group. At two sites, we will randomize 44 individuals with a subacute stroke to receive additional therapy with the MusicGlove or additional conventional therapy for four weeks. We hypothesize that the individuals who exercise with the MusicGlove will improve their Box & Block score by a clinically significant amount (6 blocks), compared to the control group. 3) Conduct a pilot study of use of the device with individuals with a chronic, cervical, incomplete SCI (months 12-24). We will also establish initial safety, feasibility, and efficacy for individuals with a SCI (n = 20), another important user group 4) Solicit feedback on usability of the device in normal clinical practice (months 12-24). We will distribute the MusicGlove to three leading rehabilitation units, and study how these units incorporate the device into their patient care. This Phase II project will result in a commercially- ready, clinically-validated product that we will produce and sell.