Development of the CopyCat FES System to Improve Hand Recovery After Stroke

开发 CopyCat FES 系统以改善中风后手部康复

• 批准号: 8523371
• 负责人: Marilyn J. Hamilton
• 金额: $ 20.01万
• 依托单位: STIMDESIGNS, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2015-05-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8523371
• 关键词: Activities of Daily Living; Address; Affect; Agreement; Ankle; Brain; Caregivers; Caring; Case Study; Chronic; Clinical; Clinical Research; Collaborations; Complement; Contracts; Custom; Dependence; Development; Devices; Direct Costs; Doctor of Medicine; Doctor of Philosophy; Elbow; Electric Stimulation; Electronics; Engineering; Ensure; Esthetics; Exercise; FPS-FES Oncogene; Feedback; Funding; Hand; Hand functions; Handwashing; Hemiplegia; Home environment; Human; Impairment; Injury; Inpatients; Intention; Knowledge; Lead; Legal patent; Licensing; Limb structure; Manufacturer Name; Marketing; Medical; Modeling; Monitor; Motor; Movement; Neurorehabilitation; Occupational Therapy; Outcome; Outpatients; Output; Paralysed; Patients; Penetration; Phase; Pilot Projects; Population; Price; Production; Randomized Controlled Trials; Recovery; Rehabilitation Research; Rehabilitation therapy; Research; Research Project Grants; Safety; Sales; Secure; Self-Administered; Site; Small Business Innovation Research Grant; Solutions; Sterile coverings; Stroke; Surface; Survivors; System; Techniques; Technology; Technology Transfer; Testing; Textiles; Translating; Translational Research; United States; Universities; Upper Extremity; Validation; Wireless Technology; acute stroke; base; chronic stroke; clinical research site; commercialization; cost; design; disability; flexibility; graphical user interface; hemiparesis; improved; innovation; instrument; meetings; motor control; multi-site trial; novel; post stroke; product development; programs; public health relevance; relating to nervous system; research study; safety testing; sensor; stroke rehabilitation; therapy design; tool; touchscreen; upper limb hemiparesis; usability; user-friendly

DESCRIPTION (provided by applicant): Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the nearly 800,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately one-third of stroke survivors develop chronic hemiparesis with significant dependence on caregivers for activities of daily living. Contralaterally controlled functional electrical stimulation (CCFES) is a new treatment designed to improve hand motor recovery through active intention-driven movement combined with repetitive stimulated movement. CCFES stimulates paretic hand opening with a stimulation intensity that is regulated by an instrumented glove worn on the unaffected hand. Therefore, volitional opening of the unaffected hand produces a proportional amount of opening of the affected hand (the paretic hand "copies" the non-paretic hand), allowing the patient to practice active, repetitive hand opening exercises and functional tasks. CCFES meets the unique demands of stroke patients by incorporating rehabilitation techniques shown to promote neural recovery and boost the brain's capacity to reorganize after injury, restoring motor control of affected limbs. CCFES treatment has been shown in two pilot case studies and in an early-phase randomized controlled trial (RCT) to reduce hand impairment and improve hand function. Ongoing studies include a large RO1 RCT of the efficacy in chronic hemiplegia, a pilot study investigating the effect of adding stimulated elbow extension to hand, an R21 RCT to improve ankle dorsiflexion, and a recently funded RO1 RCT to investigate the addition of stimulated elbow extension to hand. CCFES treatment is a scientifically proven therapy and is expected to have significant commercial potential. However, to achieve successful technology transfer of the lab-based device from single-site research studies to multi-site studies and commercialization, the research-grade device needs to be redesigned for improved manufacturability, durability, and ease-of-use and programming to make it suitable for widespread dissemination. StimDesigns LLC, in collaboration with the inventors of CCFES treatment from Case Western Reserve University, Cleveland FES Center and WIN Enterprises will develop and test the first commercial Hand CopyCat FES system in this Phase I SBIR project. The specific aims are: 1) Design and produce pre- production CopyCat FES systems that meet the design and functional specifications, and 2) Conduct functional, safety and clinical usability testing of the new CopyCat FES systems. This project is a critical step in advancing CCFES therapy and preparing for the first multi-site trail. Commercialization will not only enhance hand recovery after stroke n a desperate population looking for better solutions but also, advance the field of FES rehabilitation research.

描述（由申请人提供）：上肢轻偏瘫是中风导致的最严重和最常见的损伤之一。在美国每年发生的近800，000例中风中，约75%会导致一定程度的上肢瘫痪。大约三分之一的中风幸存者发展为慢性轻偏瘫，日常生活活动严重依赖照顾者。双侧控制功能性电刺激（CCFES）是一种通过主动意图驱动运动结合重复刺激运动来促进手部运动恢复的新疗法。CCFES刺激麻痹的手张开，刺激强度由戴在未受影响的手上的仪表手套调节。因此，未受影响的手的意志性张开产生受影响的手的成比例的张开量（麻痹的手“复制”非麻痹的手），允许患者练习主动的、重复的手张开练习和功能性任务。CCFES通过结合康复技术来满足中风患者的独特需求，这些康复技术被证明可以促进神经恢复，提高大脑在受伤后的重组能力，恢复受影响肢体的运动控制。CCFES治疗已在两项试点病例研究和一项早期随机对照试验（RCT）中显示，可减轻手部损伤并改善手部功能。正在进行的研究包括一项关于慢性偏瘫疗效的大型RO 1随机对照试验、一项调查手部增加刺激肘部伸展的影响的试点研究、一项改善脚踝背屈的R21随机对照试验，以及最近资助的一项研究增加刺激肘部伸展的RO 1随机对照试验手。CCFES治疗是一种经过科学验证的治疗方法，预计具有巨大的商业潜力。然而，为了实现基于实验室的设备从单点研究到多点研究和商业化的成功技术转移，需要重新设计研究级设备，以提高可制造性，耐用性，易用性和编程，使其适合广泛传播。StimDesigns LLC与凯斯西储大学、克利夫兰FES中心和WIN企业的CCFES治疗发明者合作，将在第一阶段SBIR项目中开发和测试第一个商业Hand CopyCat FES系统。具体目标是：1）设计和生产符合设计和功能规范的预生产CopyCat FES系统，以及2）对新的CopyCat FES系统进行功能、安全和临床可用性测试。该项目是推进CCFES治疗和准备首次多中心试验的关键一步。商业化不仅将促进中风后的手部恢复，而且将推动FES康复研究领域的发展。