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，在美国和世界各地都是导致残疾的主要原因。仅以中风为例，据估计，每年70万中风幸存者中有80%需要手部治疗。密集的康复训练可减少长期手部损伤。不幸的是，在受伤后2周，人们通常必须在没有专业帮助的情况下在家中进行手部治疗。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乐器手套，用户需要练习抓握的功能动作来玩一个定制的电脑游戏，这个游戏的灵感来自游戏史上第三大最受欢迎的电子游戏《吉他英雄》。在我们的第一阶段研究中，有16名中风患者在家中使用该设备，以及一项早期的试点研究，有9名中风患者在诊所使用该设备，我们发现MusicGlove准确地测量了临床手部损伤水平，激励人们在40分钟的训练课程中进行1400多个握力动作，并刺激手部功能比传统疗法有更大的改善。我们第二阶段的目标是：1)开发适合商业化的MusicGlove生产模型（1-12个月）。我们将修改我们的功能原型，使其强大，易于使用，并以符合fda的方式有效地制造，并将完成直观，易于使用的游戏界面的开发，该界面可以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)对亚急性脑卒中患者（12-24个月）进行双中心随机对照试验。亚急性中风患者是一个很大的潜在使用者群体。在两个地点，我们将随机抽取44名亚急性中风患者，接受为期四周的MusicGlove附加治疗或附加常规治疗。我们假设，与对照组相比，使用MusicGlove锻炼的个体将显著提高他们的Box & Block得分（6个Block）。3)对慢性，颈椎，不完全性脊髓损伤患者（12-24个月）进行设备使用的试点研究。我们还将对脊髓损伤患者（n = 20）（另一个重要的用户群体）建立初步的安全性、可行性和有效性(4)，征求设备在正常临床实践中的可用性反馈（12-24个月）。我们将把MusicGlove分发给三家领先的康复单位，并研究这些单位如何将该设备纳入他们的病人护理中。这个第二阶段的项目将产生一个商业准备，临床验证的产品，我们将生产和销售。

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.