Exoskeleton Research: Myoelectric orthosis for rehab of severe chronic arm motor deficits

目前的康复方法无法恢复许多中风幸存者的正常手臂功能， 特别是那些严重赤字的人。本研究的主要目的是测试疗效， 评估一种新方法治疗持续性脑梗死的潜在神经生理机制 中风后严重的手臂缺陷，结合MyoPro™和基于运动学习的 疗法我们还将评估这种治疗方法的成本效益。理由：电机 基于学习的治疗是可用的最有效的中风康复方法之一， 然而，其应用对于具有严重手臂损伤个体是具有挑战性的，因为 他们有限的能力来有效地练习有意识的手臂运动。MyoPro是一种外骨骼 肌电控制的矫正装置，其被定制装配到个体的麻痹手臂， 帮助使用者移动麻痹手臂。MyoPro可以帮助基于运动学习的治疗 对于有严重运动缺陷的人，因为它激励练习，因为即使是弱肌肉 活动被转化为患者发起的手臂运动。运动学习的初步结果 在我们的实验室中使用MyoPro治疗显示上肢Fugl-Meyer增加 在18周的培训（18次临床治疗，超过9次）后， 基线FM≤30的慢性卒中幸存者的随访时间为10周，随后为9周的家庭实践）。 然而，相同剂量的联合治疗与单独的运动学习相比， 还有待确定。研究设计：采用随机对照设计， 慢性重度卒中患者（术后≥6个月; Fugl Meyer UE评分≤30;n=60）将参加 MyoPro+运动学习（M+ML）或单独运动学习（ML-单独）。研究 干预将包括9周的门诊培训（18节课，每次1.5小时），然后是9周的门诊培训。 家庭训练和6周的随访。目的1是确定M+ML是否会导致 与单独使用ML相比，治疗获益更大。主要结局将是FM的变化。 次要结局指标将评估麻痹手臂的总体表现，包括： 运动学、肌张力（改良Ashworth量表; MAS）、抓握/捏夹/手臂测力法， 感觉功能（Semmes Weinstein单丝测试，关节本体感觉），手臂功能 (Arm运动能力测试（AMAT）;体动记录仪）和生活质量（卒中影响量表（SIS））。 目的2是描述治疗后大脑结构和功能的变化。成果 包括皮质脊髓兴奋性（运动诱发电位募集曲线（MEP-rc））， 功能连接（静息状态功能）磁共振成像（rs-fMRI）。目标3是 确定与治疗后更大的功能改善相关的基线因素。 结果如下：中风影响的皮质脊髓束的基线完整性（损伤负荷， MEP-rc;弥散张量成像）;受累手臂的基线运动能力（FM）;基线 功能连接（rs-fMRI）;器械使用和体动记录。目标4：评估成本 M+ML与单独ML的有效性。成果包括：直接/间接费用和健康 相关生活质量调查（简表12v.2和SIS）。意义：本研究将探讨 通过首次测试MyoPro是否 结合运动学习疗法的治疗效果上级单纯运动学习疗法 中风时手臂的慢性严重损伤如果发现有效，则研究干预是 易于部署到临床环境中。

Current rehabilitation methods fail to restore normal arm function for many stroke survivors, particularly those with severe deficits. The main objective of this study is to test efficacy and evaluate underlying neurophysiological mechanisms of a novel approach to treat persistent severe arm deficits after stroke with a combination of MyoPro™ and motor learning-based therapy. We will also estimate cost effectiveness of this therapeutic approach. Rationale: Motor learning-based therapy is one of the most effective stroke rehabilitation methods available, however its application is challenging for individuals with severe arm impairment because of their limited ability to practice volitional arm movement effectively. The MyoPro is an exoskeletal myoelectrically controlled orthotic device that is custom fitted to an individual’s paretic arm and assists the user to move the paretic arm. MyoPro can help with motor learning-based therapy for individuals with severe motor deficits as it motivates practice because even weak muscle activity is translated into patient-initiated arm movement. Preliminary results of motor-learning therapy using MyoPro in our laboratory showed an increase in Fugl-Meyer for Upper extremity score (FM) of 7.44 points following 18 weeks of training (18 in-clinic therapy sessions over 9 weeks followed by 9 weeks of home practice) for chronic stroke survivors with baseline FM≤30. However, comparison of the same dose of combination therapy with motor-learning alone remains to be determined. Study Design: Using a randomized, controlled design, individuals with chronic severe stroke (≥6 months post; Fugl Meyer UE score ≤30;n=60) will participate in either MyoPro+motor learning (M+ML) or motor learning alone (ML-alone). The study intervention will include 9 weeks of in-clinic training (18 sessions;1.5 hours each) followed by 9 weeks of home practice and a 6-week follow-up. Aim 1 is to determine whether M+ML results in greater treatment gains compared to ML-alone. The primary outcome will be change in FM. Secondary outcome measures will assess overall paretic arm performance and will include: kinematics, muscle tone (Modified Ashworth Scale; MAS), grip/pinch/arm dynamometry, sensory function (Semmes Weinstein mono-filament test, joint proprioception), arm function (Arm Motor Ability Test (AMAT);actigraphy) and quality of life (Stroke Impact Scale (SIS)). Aim 2 is to characterize structural and functional brain changes after treatment. Outcomes include corticospinal excitability (motor evoked potential recruitment curve (MEP-rc)), and functional connectivity (resting state function Magnetic Resonance Imaging(rs-fMRI). Aim 3 is to identify baseline factors associated with greater functional improvement with treatment. Outcomes are as follows: baseline integrity of the stroke-affected corticospinal tract (lesion load, MEP-rc; Diffusion Tensor Imaging); baseline motor ability of the affected arm (FM); baseline functional connectivity (rs-fMRI); device usage and actigraphy. Aim 4 is to evaluate cost effectiveness of M+ML versus ML-alone. Outcomes include: direct/indirect costs and health related quality of life surveys (Short Form 12v.2 and SIS). Significance: This study will address an important problem for the VA patient population by testing for the first time whether MyoPro combined with motor learning-based therapy is superior to motor learning alone in the treatment of chronic, severe arm impairment in stroke. If found to be effective, the study intervention is readily deployable to the clinical setting.