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.

目前的康复方法无法让许多中风幸存者恢复正常的手臂功能， 尤其是那些有严重赤字的人。本研究的主要目的是测试功效和 评估治疗持续性新方法的潜在神经生理学机制 结合使用 MyoPro™ 和基于运动学习的方法治疗中风后严重的手臂缺陷 治疗。我们还将估计这种治疗方法的成本效益。原理：电机 基于学习的治疗是最有效的中风康复方法之一， 然而，对于手臂严重受损的人来说，其应用具有挑战性，因为 他们有效练习手臂自主运动的能力有限。 MyoPro 是一种外骨骼 肌电控制矫形器，定制安装到个人的瘫痪手臂上， 帮助用户移动瘫痪手臂。 MyoPro 可以帮助进行基于运动学习的治疗 对于运动严重缺陷的人来说，因为它可以激励练习，因为即使肌肉较弱 活动被转化为患者发起的手臂运动。运动学习的初步结果 我们实验室使用 MyoPro 进行的治疗显示上肢 Fugl-Meyer 有所增加 经过 18 周的培训（18 次临床治疗疗程超过 9 次）后，评分 (FM) 为 7.44 分 针对基线 FM≤​​30 的慢性中风幸存者，进行为期 10 周的家庭练习，然后进行 9 周的家庭练习。 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 患有慢性严重中风（≥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-only）。研究 干预措施将包括 9 周的临床培训（18 次课程；每次 1.5 小时），然后是 9 周 几周的家庭练习和六周的随访。目标 1 是确定 M+ML 是否结果 与单独使用 ML 相比，治疗效果更大。主要成果将是 FM 的变化。 次要结果指标将评估偏瘫手臂的整体表现，包括： 运动学、肌肉张力（改良阿什沃斯量表；MAS）、握力/捏力/手臂测力、 感觉功能（Semmes Weinstein 单丝测试、关节本体感觉）、手臂功能 （手臂运动能力测试（AMAT）；体动记录仪）和生活质量（中风影响量表（SIS））。 目标 2 是表征治疗后大脑结构和功能的变化。结果 包括皮质脊髓兴奋性（运动诱发电位招募曲线（MEP-rc）），以及 功能连接（静息状态功能磁共振成像 (rs-fMRI)）。目标 3 是 确定与治疗后功能改善更大相关的基线因素。 结果如下：中风影响的皮质脊髓束的基线完整性（病变负荷， MEP-rc；扩散张量成像）；受影响手臂的基线运动能力（FM）；基线 功能连接（rs-fMRI）；设备使用和体动记录仪。目标 4 是评估成本 M+ML 与单独 ML 的有效性。结果包括：直接/间接成本和健康 相关生活质量调查（简表 12v.2 和 SIS）。意义：本研究将解决 首次测试 MyoPro 是否对 VA 患者群体来说是一个重要问题 与基于运动学习的治疗相结合的治疗效果优于单独运动学习的治疗 中风导致的慢性、严重手臂损伤。如果发现有效，则研究干预是 易于部署到临床环境。