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.

上肢的偏瘫是中风造成的最严重的损害之一。 每年在美国发生的795,000多人中，约有75％导致一定程度 上肢瘫痪。多达65％的中风幸存者仍然无法使用其受影响的手来协助 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气的疗法的影响 通过交互式手动治疗视频游戏刺激。拟议研究的目的是解决 需要通过评估这些治疗方法对两者的影响进行有效的上肢康复疗法 和大脑功能。 对侧控制功能电刺激（CCFE）是一种创新的神经肌肉 电刺激（NME）治疗，以改善中风后手功能的恢复。 CCFE刺激 与对侧未损坏的手的自愿性开放程度成比例地张开的手提之手。 这使中风患者能够在家中进行主动重复的手开练习并练习 实验室中的治疗师的功能任务。敏捷性，上肢障碍的显着改善， CCFE显示了和活动限制措施，但改进的幅度取决于 损害的严重性和慢性。可能会改善中等和 通过提高家庭基于家庭的运动质量，严重受损的患者。 治疗，占总治疗时间的70％。因此，在这项研究中，我们整合了CCFE 具有定制设计的注意力吸引人，以目标为导向的，需要CCFES辅助手动治疗视频 游戏（HTVG）并比较合并治疗（CCFE+HTVG）的效果与CCFE的效果 独自的。预计视频游戏组件将增强治疗效果，因为CCFE介导 游戏更面向目标，需要更大的运动计划，电动机控制和集中注意力 CCFE介导的重复打开练习，因此可能会产生更多的自适应神经塑性 大脑的影响。 该项目将注册52名慢性中风患者，并将其随机分配到12周 CCFE+HTVG或CCFE为：1）确定整合HTVG和CCFES是否会导致更大 敏捷性，障碍，活动限制和生活质量的改善，2）确定如何严重性 障碍和中风后的时间影响治疗的相对影响，从而定义 亚种群最有可能受益，3）阐明和比较治疗方法如何影响皮质 手机控制任务期间的激活（fMRI评估）。这将是第一个随机对照试验 以刺激为 在视频游戏的游戏中交付。 该项目对神经居住领域很重要，因为它认识到 结合协同疗法，为患者带来更大的好处，也认识到有必要量身定制的 为了实现最佳结果，对患者特征进行疗法。