Contralaterally Controlled FES plus Video Games for Hand Therapy after Stroke

对侧控制 FES 加上视频游戏用于中风后手部治疗

• 批准号: 10322971
• 负责人: Jayme S. Knutson
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10322971
• 关键词: Activities of Daily Living; Acute; Address; Admission activity; Affect; Area; Attention; Brain; Characteristics; Chronic; Clinical Trials; Combined Modality Therapy; Complex; Contralateral; Custom; Development; Disabled Persons; Dose; Electric Stimulation; Electric Stimulation Therapy; Electrodes; Enrollment; Exercise; Exhibits; Extensor; FPS-FES Oncogene; Feedback; Fingers; Functional Magnetic Resonance Imaging; Goals; Hand; Hand functions; Hemiplegia; Home; Hospitals; Hour; Impairment; Individual; Ischemic Stroke; Lead; Learning; Measures; Mediating; Modality; Motor; Motor Activity; Movement; Network-based; Neuronal Plasticity; Outcome; Paralysed; Paresis; Patients; Periodicity; Play; Prefrontal Cortex; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Rehabilitation therapy; Research; Research Personnel; Self Administration; Severities; Stroke; Surface; Thumb structure; Time; Treatment Protocols; United States; Upper Extremity; Veterans; Video Games; Volition; base; chronic stroke; cohesion; design; dexterity; disability; executive function; feasibility testing; functional electrical stimulation; hand rehabilitation; hand therapy; improved; improved outcome; individualized medicine; innovation; instrument; motor control; motor learning; motor rehabilitation; neurological rehabilitation; neuromuscular stimulation; post stroke; recruit; relating to nervous system; response; skills; stroke patient; stroke survivor; treatment comparison; treatment effect; treatment response; trial comparing; upper limb hemiparesis; virtual reality

Hemiparesis of the upper limb is one of the most serious impairments resulting from stroke. Approximately 75% of the over 795,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Up to 65% of stroke survivors still cannot use their affected hand to assist with activities of daily living 6 months after their stroke. The proposed project is a clinical trial that compares the effects of an innovative neuromuscular electrical stimulation therapy to a therapy that integrates the electrical stimulation with interactive hand therapy video games. The purpose of the proposed research is to address the need for effective upper limb rehabilitation therapies by evaluating the effects of these treatments on both hand and brain function. Contralaterally controlled functional electrical stimulation (CCFES) is an innovative neuromuscular electrical stimulation (NMES) treatment for improving recovery of hand function after stroke. CCFES stimulates the paretic hand to open in proportion to the degree of volitional opening of the contralateral unimpaired hand. This enables stroke patients to perform active repetitive hand opening exercises at home and practice functional tasks with a therapist in the lab. Significant improvements in dexterity, upper extremity impairment, and activity limitation measures have been shown with CCFES, but the magnitude of improvement depends on the severity and chronicity of impairment. It may be possible to improve outcomes in both moderately and severely impaired patients by increasing the motor relearning qualities of the home-based part of the treatment, which comprises 70% of the total treatment hours. Therefore, in this study, we integrate CCFES with custom-designed attention-engaging, goal-oriented, skill-requiring CCFES-assisted hand therapy video games (HTVG) and compare the effects of the combined treatment (CCFES+HTVG) to the effects of CCFES alone. The video game component is expected to enhance the treatment effect because the CCFES-mediated games are more goal-oriented and require greater motor planning, motor control, and concentration than CCFES-mediated repetitive hand opening exercises, and therefore may produce more adaptive neuroplastic effects in the brain. This project will enroll 52 chronic stroke patients and randomize them to 12 weeks of either CCFES+HTVG or CCFES in order to: 1) determine if integrating HTVG and CCFES leads to greater improvement in dexterity, impairment, activity limitation, and quality of life, 2) determine how severity of impairment and time post-stroke influences the relative effects of the treatments, thereby defining subpopulations most likely to benefit, and 3) elucidate and compare how the treatments affect cortical activation during a hand motor control task (fMRI assessment). This will be the first randomized controlled trial that integrates video games and neuromuscular electrical stimulation in such a way that the stimulation is delivered during play of the video games. This project is important to the field of neurorehabilitation because it recognizes the potential of combining synergistic therapies to achieve greater benefits for patients, and also recognizes the need to tailor therapies to patient characteristics in order to achieve the best possible outcomes.

上肢偏瘫是中风引起的最严重的损伤之一。 美国每年发生超过 795,000 起中风，其中大约 75% 是由某种程度的中风引起的 上肢瘫痪。高达 65% 的中风幸存者仍然无法使用受影响的手来协助 中风后 6 个月的日常生活活动。拟议的项目是一项临床试验，比较 创新的神经肌肉电刺激疗法对整合电疗法的效果 通过互动手部治疗视频游戏进行刺激。拟议研究的目的是解决 通过评估这些治疗对双手的效果，需要有效的上肢康复治疗 和大脑功能。 对侧控制功能性电刺激（CCFES）是一种创新的神经肌肉刺激 电刺激（NMES）治疗可改善中风后手部功能的恢复。 CCFES 刺激 瘫痪手的张开程度与对侧未受损手的自愿张开程度成比例。 这使得中风患者能够在家中进行主动重复的张手练习和练习 在实验室与治疗师一起完成功能性任务。灵活性显着改善，上肢损伤， 和活动限制措施已通过CCFES展示，但改善的幅度取决于 损害的严重程度和长期性。有可能改善中等和中等程度的结果 通过提高家庭部分的运动再学习质量来帮助严重受损的患者 治疗时间占总治疗时间的 70%。因此，在本研究中，我们整合了CCFES 定制设计的吸引注意力、目标导向、需要技能的 CCFES 辅助手部治疗视频 游戏（HTVG）并将联合治疗（CCFES+HTVG）的效果与CCFES的效果进行比较 独自的。视频游戏成分有望增强治疗效果，因为 CCFES 介导的 游戏更加以目标为导向，需要更多的运动规划、运动控制和注意力。 CCFES 介导的重复张手练习，因此可能产生更具适应性的神经可塑性 对大脑的影响。 该项目将招募 52 名慢性中风患者，并将他们随机分为 12 周 CCFES+HTVG 或 CCFES，以便： 1) 确定 HTVG 和 CCFES 的集成是否会带来更大的结果 灵活性、损伤、活动限制和生活质量的改善，2) 确定疾病的严重程度 损伤和中风后时间影响治疗的相对效果，从而定义 最有可能受益的亚群，以及 3) 阐明并比较治疗如何影响皮质 手部运动控制任务期间的激活（功能磁共振成像评估）。这将是第一个随机对照试验 它将视频游戏和神经肌肉电刺激结合在一起，使刺激 在玩视频游戏期间传递。 该项目对神经康复领域很重要，因为它认识到了神经康复的潜力 结合协同疗法可以为患者带来更大的益处，并且还认识到需要量身定制 根据患者的特点进行治疗，以达到最佳的治疗效果。