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

用于训练和评估手部功能的基于音乐的康复装置

• 批准号: 8790761
• 负责人: Nizan Friedman
• 金额: $ 92.35万
• 依托单位: FLINT REHABILITATION DEVICES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8790761
• 关键词: Activities of Daily Living; Address; Affect; Books; Boxing; Cervical; Chicago; Chronic; Clinic; Clinical; Computers; Consult; Contractor; Control Groups; Controlled Study; Custom; Data; Data Analyses; Development; Device Designs; Devices; Electronics; Exercise; Feedback; Future; Goals; Habits; Hand; Hand functions; Health; Home environment; Hospitals; Hour; Impairment; Individual; Injury; Institutes; Interview; Life; Living Standards; Measures; Medical center; Modeling; Movement; Music; Neurologic; Outcome; Pathway interactions; Patient Care; Patients; Pattern; Performance; Phase; Pilot Projects; Play; Positioning Attribute; Procedures; Production; Public Health; Quality Control; Questionnaires; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Regimen; Rehabilitation device; Rehabilitation therapy; Research; Safety; Saint Jude Children' s Research Hospital; Site; Societies; Solutions; Spinal cord injury; Stroke; Survivors; Technology; Testing; Training; United States; Upper Extremity; Video Games; Wireless Technology; Wrist; Writing; acute stroke; base; clinical practice; clinically significant; commercialization; control trial; conventional therapy; cost; design; disability; experience; follow-up; grasp; hand therapy; improved; instrument; interest; motor impairment; next generation; novel; phase 1 study; programs; prototype; routine practice; sensor; usability

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.

描述（由申请人提供）：手部损伤是一种常见的疾病，在美国和世界各地对残疾有很大的贡献。仅就中风而言，据估计，每年70万中风幸存者中有80%需要手部治疗。强化康复训练可减少长期手部损伤。不幸的是，在受伤后2周内，人们通常必须在没有专业帮助的情况下在家进行手部治疗。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，这是一种价格实惠的仪器手套，需要用户练习功能性抓握动作来玩自定义电脑游戏，其灵感来自游戏历史上第三大最受欢迎的视频游戏吉他英雄。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超过1400次练习抓握动作，并且比常规疗法刺激手功能的显著更大改善。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，使其坚固耐用，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，该界面可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，以改进未来的模型。2)在亚急性卒中患者（12-24个月）中进行该器械的双中心随机对照试验。亚急性卒中患者是一个巨大的潜在用户群体。在两个研究中心，我们将随机选择44名亚急性卒中患者，接受为期四周的MusicGlove额外治疗或额外常规治疗。我们假设，与对照组相比，使用MusicGlove进行锻炼的个体将通过临床显著量（6块）改善其Box & Block评分。3)对患有慢性、颈椎、不完全SCI的患者（12-24个月）使用该器械进行初步研究。我们还将为SCI患者（n = 20）（另一个重要用户群体）建立初步安全性、可行性和有效性4）征求有关该设备在正常临床实践中可用性的反馈（12-24个月）。我们将把MusicGlove分发给三个主要的康复单位，并研究这些单位如何将该设备纳入他们的病人护理中。该第二阶段项目将产生一种商业化的、经过临床验证的产品，我们将生产和销售该产品。

项目成果

Feasibility of Wearable Sensing for In-Home Finger Rehabilitation Early After Stroke.

• DOI: 10.1109/tnsre.2020.2988177
• 发表时间: 2020-06
• 期刊: IEEE TRANSACTIONS ON NEURAL SYSTEMS AND REHABILITATION ENGINEERING
• 影响因子: 4.9
• 作者: Sanders, Quentin;Chan, Vicky;Augsburger, Renee;Cramer, Steven C.;Reinkensmeyer, David J.;Do, An H.
• 通讯作者: Do, An H.