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

用于测量和激励中风后手部使用的交互式可穿戴设备

• 批准号: 9046229
• 负责人: Nizan Friedman
• 金额: $ 65.85万
• 依托单位: FLINT REHABILITATION DEVICES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-18 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9046229
• 关键词: Acceleration; Accelerometer; Activities of Daily Living; Blood Pressure; Body mass index; Books; Boxing; Clinical; Computer software; Development; Devices; Eating; Effectiveness; Ensure; Exercise; Feedback; Goals; Grant; Hand; Hand functions; Health; Home environment; Impairment; Individual; Injury; Interview; Life; Limb structure; Living Standards; Magnetism; Marketing; Measures; Modeling; Monitor; Motor Activity; Movement; Neurologic; Outcome; Participant; Pathway interactions; Patients; Phase; Pilot Projects; Production; Public Health; Questionnaires; Randomized Controlled Trials; Recovery; Recovery of Function; Rehabilitation therapy; Research; Small Business Innovation Research Grant; Societies; Stroke; Technology; Testing; Time; Upper Extremity; Variant; Walking; Wrist; arm; arm movement; base; chronic stroke; commercialization; cost; design; dexterity; disability; exercise program; fitness; improved; interactive feedback; magnetic field; motor impairment; movement practice; novel; public health relevance; sensor; standard of care; tool; usability

 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.

 描述（由申请人提供）：每年70万中风幸存者中约有50%患有持续性上肢损伤。这一比例如此之高的一个原因是，他们进行的康复练习运动数量太少。理想情况下，患有中风的个体将通过在一天中定期尝试使用其受损肢体进行功能活动来增强其临床治疗，但由于使用受损肢体需要更大的努力，目前情况并非如此。正如最近在JAMA上评论的那样，每日计步器反馈已被证明是增加许多人步行活动的有效方法。因此，SBIR项目第二阶段的目标是开发和生产一种交互式“手部计步器”，为中风后寻求上肢康复的人提供类似的益处。我们开发了首款磁性传感器Manumeter，以社会可接受且易于穿戴的方式无线检测手部和手臂运动。用户佩戴一个小型永磁体作为戒指，传感/记录腕带检测戒指移动时磁场的变化;腕带也检测手臂加速度。我们在最初的研究中已经表明，Manumeter可以准确地量化功能活动的数量。因此，我们假设中风患者使用Manumeter测量和激励上肢功能使用将改善他们的恢复。第二阶段资助的目的是：1）开发适合商业化（1-24个月）的Manumeter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）整合三种新型交互反馈功能; c）与专业制造公司合作，大规模生产符合FDA标准的商业版本。2)对慢性卒中患者进行可用性研究，以确保器械易于使用且具有吸引力（3-12个月）。3)在一项针对慢性卒中患者（12-24个月）的初步随机对照试验中，确定Manumeter的交互式反馈在改善上肢功能方面的有效性。在本研究中， 11名参与者将使用Manumeter的交互式反馈功能来监测和激励上肢功能活动; 11名对照参与者将佩戴Manumeter，但没有收到反馈，并将获得用于增加上肢锻炼的当前护理标准，一本家庭锻炼书。我们假设，与Manumeter互动监测功能活动的个人将改善他们的上肢功能显着更多的测量框和块评分，ARAT，运动活动日志，Fugl-Meyer评分，和Manumeter本身。该项目将产生一个商业化的，临床验证的产品，我们将生产和销售。