Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke

描述(申请人提供)：在美国的570万中风幸存者中，绝大多数都表现出严重的手臂无力(称为“偏瘫”)。这种破坏性的损害损害了有价值的活动和生活质量的表现。然而，传统的受影响的ARM策略有负面证据，或者没有证据支持它们的使用。较新的康复方法强调重复的、特定任务的练习(RTP)，包括受影响的手臂。然而，这些有希望的方案中有许多需要参与强化治疗，而且大多数只对损伤最小的患者有效。因此，仍然需要一种有效的、实用的RTP技术来解决中度到重度的手臂偏瘫。 为了解决上述不足，开发了一种将肌电(EMG)和机器人技术相结合的创新支架。一位研究小组成员收集的数据表明，在中度受损的慢性中风患者中，使用支具(称为“Myomo”)和RTP联合使用可以减少受影响的手臂损伤。下一步，这项疗效研究将随机选择30名手臂中度受损的慢性中风患者接受：(A)Myomo联合RTP(Myomo+RTP)；(B)仅RTP(RTP)；或(C)仅Myomo治疗(Myomo)。这项研究设计将解决应用程序的目标，即收集随机的、受控的飞行员数据，评估Myomo的临床有效性。根据研究小组的临床经验和支架的试验数据，中心假设是，接受Myomo疗法和RTP联合治疗的受试者将显示出显著的损伤减轻。结果包括受影响的手臂损伤(主要终点)、实验室和社区活动受限、生活质量和运动学。PIs将检验他们的中心假设，并通过追求以下特定目标来实现他们的目标：(1)比较Myomo+RTP与仅RTP和仅Myomo对受影响手臂损伤的疗效；(2)确定Myomo+RTP对受影响手臂预后的影响；(3)评估Myomo+RTP对运动运动学的影响。 与公共健康相关：在美国，中风是导致残疾的主要原因，会导致运动障碍，影响有价值的活动的表现。偏瘫尤其致残，是中风相关残疾的主要损害，也是美国治疗师治疗的最常见的损害。这项研究将测试一项有前景的技术在减少残疾和增加功能，从而改善结果和健康，并降低护理费用，社区居住的中风导致的偏瘫患者的有效性。

DESCRIPTION (provided by applicant): Of the 5.7 million stroke survivors in the United States, the vast majority exhibit significant arm weakness (called "hemiparesis"). This devastating impairment undermines performance of valued activities and quality of life. Yet, conventional affected arm strategies have negative evidence, or no evidence, supporting their use. Newer rehabilitative approaches emphasize repetitive, task-specific practice (RTP) incorporating the affected arm. However, many of these promising regimens require participation in intensive therapies, and most are only efficacious on the least impaired patients. Thus, there remains a need for an efficacious, practical RTP technique to address moderate to severe affected arm hemiparesis. To address above shortfalls, an innovative brace integrating electromyography (EMG) and robotics has been developed. Data collected by a study team member suggest that use of the brace (called "the Myomo") in conjunction with RTP reduces affected arm impairment in moderately impaired, chronic stroke patients. As a next step, this efficacy study will randomize 30 chronic stroke patients exhibiting moderate affected arm deficits to receive: (a) Myomo combined with RTP (Myomo + RTP); (b) RTP only (RTP); or (c) Myomo therapy only (Myomo). This study design will address the objective of the application, which is to collect randomized, controlled pilot data estimating Myomo clinical effectiveness. Based on the study team's clinical experiences and pilot data with the brace, the central hypothesis is that subjects administered Myomo therapy in combination with RTP will exhibit significant impairment reductions. Outcomes include affected arm impairment (primary endpoint), activity restriction in the lab and community, quality of life and kinematics. The PIs will test their central hypothesis and accomplish their objective by pursuing the following specific aims: (1) Compare efficacy of Myomo + RTP with RTP only and Myomo only on affected arm impairment; (2) Determine the impact of Myomo + RTP on affected arm outcomes; (3) Estimate the effect of Myomo + RTP on movement kinematics. PUBLIC HEALTH RELEVANCE: Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing disability and increasing function, thereby improving outcomes and health, and reducing care costs, for community dwelling patients with stroke-induced hemiparesis.