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

描述(申请人提供)：手损伤是一种常见的疾病，在美国和世界各地都是导致残疾的主要原因。仅就中风而言，据估计，每年在中风中幸存下来的70万人中有80%需要手部治疗。强化的康复运动可以减少长期的手部损伤。不幸的是，在受伤两周后，人们往往必须在没有专业帮助的情况下在家里进行手部治疗。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，这是一款价格实惠的仪表式手套，需要用户练习功能性抓握动作，才能玩一款定制的电脑游戏，灵感来自游戏史上第三大最受欢迎的视频游戏《吉他英雄》。在我们对16名在家中使用该设备的中风患者进行的第一阶段研究，以及对9名在诊所使用该设备的中风患者的早期试点研究中，我们发现MusicGlove准确地测量了临床手损伤程度，激励人们在40分钟的训练课程中进行1400多个练习握力动作，并刺激手功能比传统疗法显著改善。我们第二阶段的目标是：1)开发一种适合商业化(1-12个月)的MusicGlove生产模式。我们将修改我们的功能原型，使其坚固、易于使用，并以符合FDA的方式高效制造，并将完成直观、易于使用的游戏界面的开发，该界面将自动量化和记录用户的运动和使用习惯。我们还将开发下一代技术，以改进未来的车型。2)对亚急性中风患者(12-24个月)进行该设备的两点随机对照试验。亚急性中风患者是一个庞大的潜在用户群体。在两个地点，我们将随机选择44名亚急性中风患者，接受为期四周的MusicGlove额外治疗或额外的常规治疗。我们假设，与控制组相比，使用MusicGlove锻炼的个体将在临床上显著提高他们的Box&Block分数(6个积木)。3)对患有慢性、颈部、不完全性脊髓损伤的患者(12-24个月)进行使用该设备的试点研究。我们还将为患有脊髓损伤的患者(n=20)建立初步的安全性、可行性和有效性，这是另一个重要的用户群体4)在正常的临床实践中(12-24个月)征求对该设备可用性的反馈。我们将把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融入他们的患者护理中。这个第二阶段的项目将产生一种商业化的、经过临床验证的产品，我们将生产和销售这种产品。

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 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.