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

外骨骼研究：用于严重慢性手臂运动缺陷康复的肌电矫形器

• 批准号: 10609509
• 负责人: SVETLANA PUNDIK
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10609509
• 关键词: 3-Dimensional; Accelerometer; Address; Adherence; Affect; Aftercare; American; Brain; Caregiver support; Caring; Chronic; Clinic; Clinical; Combined Modality Therapy; Corticospinal Tracts; Custom; Devices; Diffusion Magnetic Resonance Imaging; Dose; Effectiveness; Electromyography; Facilities and Administrative Costs; Functional Magnetic Resonance Imaging; Future; Goals; Health Services Accessibility; Health Surveys; Home; Hour; Impairment; Individual; Intervention; Intervention Studies; Joints; Laboratories; Lesion; Limb structure; Magnetic Resonance Imaging; Measures; Methods; Motion; Motor; Motor Evoked Potentials; Movement; Muscle; Muscle Tonus; Muscle Weakness; Neuronal Plasticity; Optics; Orthotic Devices; Outcome; Outcome Measure; Patients; Performance; Personal Satisfaction; Phase; Population Intervention; Predictive Factor; Proprioception; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Rehabilitation therapy; Research; Research Design; Rest; Sensory; Signal Transduction; Stroke; Structure; Surveys; System; Testing; Time; Training; Translating; United States Department of Veterans Affairs; Upper Extremity; Upper limb movement; Veterans; actigraphy; arm; arm function; arm movement; arm paresis; biomarker identification; care costs; chronic stroke; clinical practice; cost; cost effective; cost effectiveness; cost estimate; cost-effectiveness evaluation; design; disability; efficacy study; efficacy testing; exoskeleton; follow-up; functional improvement; grasp; health related quality of life; improved; improved outcome; insight; interest; kinematics; military veteran; motor deficit; motor impairment; motor learning; neurophysiology; novel; novel strategies; patient population; post stroke; primary outcome; recruit; response; rural area; secondary outcome; stroke rehabilitation; stroke survivor; therapeutic effectiveness; treatment effect; treatment group; treatment response; white matter

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.

当前的康复方法无法恢复许多中风存活的正常手臂功能， 特别是那些严重缺陷的人。这项研究的主要目的是测试效率和 评估一种新方法的基本神经生理机制来治疗持久性 严重的手臂在中风后与MyoPro™和基于运动学习的组合定义 治疗。我们还将估计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 但是，它的应用是针对严重手臂损伤的人的挑战 他们有限的有效练习视力运动的能力有效。 Myopro是外骨骼 肌电控制的矫形器设备可定制适用于个人的侧臂和 协助用户移动侧臂。 Myopro可以帮助进行基于运动学习的治疗 对于患有严重运动的人，它会激发练习，因为即使是肌肉弱 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的治疗显示上肢的Fugl-Meyer有所增加 经过18周的训练后，得分（FM）为7.4°4分（18个超过9次临床治疗课程 几周，然后进行9周的家庭练习），用于基线FM≤30的慢性中风存活。 但是，单独使用相同剂量的组合疗法与单独运动学习的比较 仍有待确定。研究设计：使用随机，控制的设计，个人 随着慢性严重中风（后≥6个月； Fugl Meyer UE得分≤30; n = 60）将参加 单独使用Myopro+运动学习（M+mL）或运动学习（单独使用ML）。研究 干预措施将包括9周的临床训练（18个课程；每次1.5小时），然后是9周 几周的家庭练习和为期6周的随访。目标1是确定M+ML是否结果 在更大的治疗收益中，与单独的ML相比。主要结果将是FM的变化。 次要结果指标将评估总体臂的整体性能，并包括： 运动学，肌肉音（改良的Ashworth量表； MAS），抓地力/捏/手臂八角体， 感觉函数（Semmes Weinstein Mono-Filement测试，联合本体感受），ARM功能 （ARM运动能力测试（AMAT）；行动学）和生活质量（中风冲击量表（SIS））。 目的2是在治疗后表征结构和功能性大脑的变化。结果 包括皮质脊髓刺激性（运动诱发的潜在招聘曲线（MEP-RC））和 功能连接性（静止状态函数磁共振成像（RS-FMRI）。目标3是 确定与治疗功能改善相关的基线因素。 结果如下：受中风影响皮层脊髓束的基线完整性（病变负荷， MEP-RC;扩散张量成像）；受影响臂（FM）的基线运动能力；基线 功能连接性（RS-FMRI）;设备的使用和行为。目标4是评估成本 M+ML与ML-NONE的有效性。结果包括：直接/间接成本和健康 相关的生活质量调查（简短表格12v.2和SIS）。意义：这项研究将解决 VA患者人群首次测试Myopro是否是一个重要的问题 在治疗中，与基于运动学习的治疗相结合，仅优于运动学习 中风中慢性严重的手臂障碍。如果发现有效，研究干预是 容易部署到临床环境。