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， 尤其是那些赤字严重的国家。这项研究的主要目的是测试疗效和 评估一种治疗持续性疾病的新方法的潜在神经生理机制 MYOPRO™和基于运动学习的组合应用于卒中后严重的手臂缺陷 心理治疗。我们还将评估这种治疗方法的成本效益。基本原理：马达 基于学习的治疗是现有的最有效的中风康复方法之一， 然而，它的应用对患有严重手臂损伤的个人来说是具有挑战性的，因为 他们有效练习任意性手臂动作的能力有限。MyoPro是一种外骨骼 肌电控制的矫形器，是定制安装在个人的偏瘫手臂上，并 帮助用户移动偏瘫的手臂。MyoPro可以帮助进行基于运动学习的治疗 对于有严重运动障碍的人来说，因为这会激励练习，因为即使是虚弱的肌肉 活动被转化为患者发起的手臂运动。运动学习的初步结果 我们实验室使用MyoPro的治疗显示上肢的Fugl-Meyer增加 经过18周的训练，得分(FM)为7.4分(9周以上的18次临床治疗 对于慢性中风幸存者，使用基线FM≤30进行治疗(先进行9周的家庭训练)。 然而，相同剂量的联合治疗与单独运动学习的比较 仍有待确定。研究设计：采用随机对照设计，个体 患有慢性重度中风(≥6个月后；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-Alone)。这项研究 干预将包括9周的门诊培训(18节，每节1.5小时)，然后是9周 数周的家庭训练和6周的随访。目标1是确定M ML结果 与单独使用ML相比，在治疗方面有更大的收益。主要结果将是FM的变化。 次要结果评估将评估瘫痪手臂的整体表现，并将包括： 运动学、肌肉张力(改良的Ashworth量表；MAS)、握力/握力/手臂测力， 感觉功能(塞姆斯-温斯坦单丝测试、关节本体感觉)、手臂功能 (手臂运动能力测试(AMAT)；动作图)和生活质量(卒中影响量表(SIS))。 目标2是描述治疗后大脑结构和功能的变化。结果 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(病变负荷， 弥散张量成像(MEP-RC；弥散张量成像)；受累手臂的基线运动能力(FM)；基线 功能连通性(RS-fMRI)；设备使用和活动描记。目标4是评估成本 M ML与单独使用ML的有效性比较。结果包括：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：这项研究将解决 通过首次检测MyoPro是否为VA患者人群的一个重要问题 运动学习为主的综合治疗效果优于单纯运动学习治疗。 中风导致的慢性严重手臂损伤。如果发现是有效的，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.