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: 10420277
• 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/10420277
• 关键词: 3-Dimensional; Accelerometer; Address; Adherence; Affect; Aftercare; American; Biological Markers; Brain; Caregiver support; Caring; Chronic; Clinic; Clinical; Combined Modality Therapy; Corticospinal Tracts; Custom; Devices; Diffusion Magnetic Resonance Imaging; Dose; Effectiveness; Facilities and Administrative Costs; Filament; 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; Neuronal Plasticity; Optics; Orthotic Devices; Outcome; Outcome Measure; Patients; Performance; Personal Satisfaction; Phase; Population Intervention; Predictive Factor; Proprioception; Protocols documentation; Quality of life; 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; Volition; actigraphy; arm; arm function; arm movement; arm paresis; base; 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 functioning; improved outcome; insight; interest; kinematics; military veteran; motor deficit; motor impairment; motor learning; neurophysiology; novel; novel strategies; patient population; post stroke; primary outcome; randomized controlled design; 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使许多中风幸存者恢复正常的手臂功能，