An interactive, wearable device for measuring and motivating hand use after stroke

 描述(申请人提供)：每年在中风中存活下来的70万人中，大约有50%的人有持续性的上肢损伤。这一比例如此之高的原因之一是他们所进行的康复练习动作的数量太少。理想情况下，中风患者会通过有规律地尝试使用受损肢体进行全天的功能活动来加强临床治疗，但目前情况并非如此，因为使用受损肢体需要付出更大的努力。正如最近发表在《美国医学会杂志》上的评论，对许多人来说，每日计步器反馈已被证明是增加步行活动的有效方法。因此，这一SBIR二期项目的目标是开发和生产一种交互式的“手部计步器”，为寻求中风后上肢康复的人提供类似的好处。我们开发了第一款磁性传感器--压力计，以社会可接受和易于佩戴的包装无线检测手和手臂的运动。用户佩戴一块小的永久磁铁作为戒指，传感/记录腕带检测戒指移动时磁场的变化；腕带还检测手臂的加速度。我们已经在初步研究中表明，压力计可以准确地量化功能活动量。因此，我们假设，中风患者使用压力计测量和激发其上肢的功能使用将改善他们的恢复。这笔第二阶段赠款的目的是：1)开发适合商业化(1-24个月)的压力计生产模型，方法是a)设计坚固、可扩展和有吸引力的硬件组件；b)结合三种新颖的交互反馈功能；以及c)与专业制造公司合作，大规模生产符合FDA标准的商用版本。2)对慢性中风患者进行可用性研究，以确保设备易于使用和有吸引力(3-12个月)。3)在一项针对慢性中风患者(12-24个月)的先导性随机对照试验中，确定来自指压计的互动反馈在改善上肢功能方面的有效性。在这项研究中， 11名参与者将使用Manumeter的交互反馈功能来监控和激励上肢功能活动；11名对照参与者将佩戴Manumeter，但不会收到任何反馈，并将获得目前的护理标准，以增加上肢锻炼，这是一本关于家庭锻炼的书。我们假设，与血压计互动监测功能活动的个体将显著改善他们的上肢功能，如盒子和块评分、ARAT、运动活动日志、Fugl-Meyer评分和血压计本身。该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): Approximately 50% of the 700,000 individuals who survive a stroke each year have persistent upper extremity impairment. One reason why this percentage is so high is that the number of rehabilitative practice movements that they perform is too small. Ideally, individuals with a stroke would augment their clinical therapy by regularly attempting to use their impaired limb for functional activities throughout their day, yet this is currently not the case due to the greater effort required to use the impaired limb. As recently reviewed in JAMA, daily pedometer feedback has proven to be an effective way to increase walking activity for many individuals. Thus, the goal of this Phase II SBIR project is to develop and productize an interactive "pedometer for the hand" that will provide a similar benefit to people seeking upper extremity recovery after stroke. We have developed a first-of-its-kind magnetic sensor, the Manumeter, to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The user wears a small permanent magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband detects arm accelerations also. We have shown in initial studies that the Manumeter can accurately quantify amounts of functional activity. We thus hypothesize that people with a stroke who use the Manumeter to measure and motivate functional use of their upper extremity will improve their recovery. The aims of this Phase II grant are to: 1) Develop a production model of the Manumeter suitable for commercialization (months 1-24) by a) designing robust, scalable, and attractive hardware components; b) incorporating three novel interactive feedback functions; and c) partnering with a professional manufacturing firm to produce a commercial, FDA compliant version at scale. 2) Perform a usability study with individuals with a chronic stroke to make sure the device is easy to use and attractive (months 3-12). 3) Determine the effectiveness of interactive feedback from the Manumeter in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients (months 12-24). In this study, eleven participants will use the Manumeter's interactive feedback functions to monitor and motivate upper extremity functional activity; eleven control participants will wear a Manumeter but receive no feedback and will be given the current standard-of-care for increasing upper extremity exercise, a book of home exercises. We hypothesize that the individuals who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more as measured by the Box and Blocks score, ARAT, Motor Activity Log, Fugl-Meyer score, and Manumeter itself. This project will result in a commercially-ready, clinically-validated product that we will produce and sell.