Lever Actuated Rehabilitation of the Arm using Wheelchair Propulsion and Computer Gaming

 描述（由申请人提供）：手臂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。例如，据估计，每年70万中风幸存者中有80%需要手臂治疗。强化康复可以减少长期的手臂损伤，特别是在中风后早期进行。不幸的是，在住院康复期间与治疗师在一起的时间是有限的，患有严重损伤的人缺乏激励和有效的工具来增加他们接受的治疗剂量。为了解决这一问题，我们开发了LARA：一种辅助的，双驱动轮椅，专门设计用于通过重复的肘/肩屈曲/伸展运动提供手臂康复。在试点研究中，我们发现12名手臂严重受损的人中有12名能够使用LARA，他们的受损手臂在轮椅上移动50英尺，并在LARA的固定模式下锻炼时玩基于治疗的电脑游戏。因此，通过使用LARA作为他们每天通常在轮椅上花费的几个小时的轮椅，住院患者将能够使用他们受损的手臂步行到他们的治疗预约，自助餐厅等，而不是像现在这样被动地由看护者推动或仅使用他们的好胳膊和脚来推动。他们还可以在自己的房间或诊所公共休息室轻松访问基于治疗的游戏。因此，他们将比目前的实践多实现数千个康复练习动作，改善他们的手臂运动恢复。我们第二阶段的目标是：1）开发适合商业化的LARA生产模型（1-24个月）。我们将修改我们的功能原型，使其坚固、可扩展、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。2)对亚急性卒中患者（12-24个月）进行器械随机对照试验。亚急性卒中患者是一个巨大的潜在用户群体。通过与加州大学欧文分校的联盟，我们将随机选择44名亚急性卒中患者，在住院期间使用LARA或接受额外的常规治疗。我们假设使用LARA锻炼和步行到他们的约会的个人将改善他们的Fugl-Meyer评分的临床显著量（7分）超过对照组，在三个月的随访评估。3)征求关于器械在正常临床实践中可用性的反馈（月 12-24）。我们将把LARA分发给两个主要的康复单位，并研究这些单位如何将该设备纳入他们的病人护理。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。

 DESCRIPTION (provided by applicant): Arm impairment is a common condition that contributes substantially to disability in the U.S. and around the world. For example, it is estimated that 80% of the 700,000 individuals who survive a stroke each year require arm therapy. Intensive rehabilitation reduces long-term arm impairment, especially when performed early after stroke. Unfortunately, time with a therapist is limited during inpatient rehabilitation and individuals with severe impairment lack motivating and effective tools to increase the dose of therapy they receive. To address this problem, we have developed LARA: an assistive, lever-drive wheelchair specifically designed to provide arm rehabilitation through repetitive elbow/shoulder flexion/extension exercise. In pilot studies, we found 12 out of 12 individuals with severe arm impairment were able to use LARA with their impaired arm to move 50 feet overground in their wheelchair and to play engaging therapy-based computer games while exercising in LARA's stationary mode. Thus, by using LARA as their wheelchair for the several hours per day they normally spend in a wheelchair, inpatients will be able to use their impaired arm to ambulate to their therapy appointments, the cafeteria, etc., rather than being passively pushed by a caregiver or by using only their good arm and foot, as is now the case. They will also be able to easily access the therapy-based games in their room or in the clinic common room. They will thus achieve thousands more rehabilitation practice movements than is current practice, improving their arm movement recovery. Our aims for Phase II are to: 1) Develop a production model of LARA suitable for commercialization (months 1-24). We will modify our functional prototype to be robust, maneuverable, 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. 2) Perform a randomized controlled trial of the device with sub-acute stroke patients (months 12-24). Individuals with subacute stroke are a large potential user group. Through a consortium with UC Irvine, we will randomize 44 individuals with a subacute stroke to use LARA or receive additional conventional therapy during their inpatient stay. We hypothesize that the individuals who use LARA to exercise and ambulate to their appointments will improve their Fugl-Meyer score by a clinically significant amount (7 points) more the control group as assessed at a three month follow-up. 3) Solicit feedback on usability of the device in normal clinical practice (months 12-24). We will distribute LARA to two 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.