Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke

项目摘要：卒中后手损伤普遍、持续、难以治疗，呈阴性 对功能能力和独立性的影响。提高治疗效果的一种方法是加强治疗 有外周感官刺激。虽然前景看好，但大多数感觉刺激方式都会干扰 自然的手部任务。因此，它们在治疗前给药，需要额外的时间投入和 妨碍患者坚持和执行。此外，刺激后的效果会减弱，从而削弱其 在治疗过程中的效力。解决现有感官刺激的局限性并充分利用治疗性 感觉刺激的好处，一种新的感觉刺激‘TheraBraclet’已经被开发出来：一款手表 在任务练习中应用潜意识的振动来刺激感觉运动皮层神经元 在手部任务中激发，导致增强神经交流和手部功能恢复。目标是 这个项目的目的是确定TheraBraclet与手工练习相结合是否优于手工练习 在动力充足的学习中独自练习。研究设计为双盲随机对照 审判。慢性中风幸存者将接受标准化的手部任务练习治疗计划(每周3天 6周)，并将TheraBraclet装置戴在偏瘫的手腕上。该设备将为 治疗组无振动，对照组无振动。双盲是可能的，因为治疗 振动是难以察觉的。评估将在基线、治疗2周、4周和6周以及1个月时进行 之后。目的1：探讨TheraBraclet在改善手功能恢复方面的临床应用潜力。 假设：手部运动功能的改善，治疗组优于对照组。手部功能 将使用Wolf运动功能、框和块以及行动研究ARM测试进行评估，以及 日常生活中上肢使用的数量/质量、日常活动能力和参与者反馈。 目的：研究TheraBraclet对感觉运动握力控制和神经通讯的影响。 假设：该治疗将增强握手的感觉运动握力控制和神经通讯 与对照组相比。感觉运动握力控制将使用成熟的生物力学进行评估 指向力的测量、方向控制和握力的有效定标。神经 握手的交流将被量化为皮层感觉运动中脑电连贯性的增加 与休息相比，抓握的网络。二次分析将包括描述影响的时间进程 和响应者分析。影响：这项研究将确定该新药的临床实用性和生物标志物 刺激，引导潜在的翻译。这项研究是翻译的，因为这种刺激是在一个 美观的智能手表，不会干扰手的运动，可以很容易地集成到临床上 练习一下。加强手功能应显著提高卒中幸存者的独立性和生活质量 生活，减轻照顾者负担。

Project Summary: Post-stroke hand impairment is prevalent, persistent, and difficult to treat, with negative impact on functional ability and independence. One way to improve treatment efficacy is to augment therapy with peripheral sensory stimulation. While promising, most modalities of sensory stimulation interfere with natural hand tasks. Thus they are administered prior to therapy, requiring additional time commitment and hindering patient adherence and implementation. Further, effects diminish after stimulation, weakening its potency during therapy. To address limitations of existing sensory stimulation and fully leverage the therapeutic benefits of sensory stimulation, a novel sensory stimulation `TheraBracelet' has been developed: A wristwatch applies imperceptible vibration during task practice to stimulate the sensorimotor cortex neurons for coherent firing during hand tasks, leading to enhanced neural communication and hand function recovery. The objective of this project is to determine if combining TheraBracelet with hand task practice is superior to hand task practice alone in an adequately powered study. The study design is a double-blinded randomized controlled trial. Chronic stroke survivors will undergo a standardized hand task-practice therapy program (3 days/week for 6 weeks) with the TheraBracelet device worn on the paretic wrist. The device will deliver vibration for the treatment group and no vibration for the control group. Double blinding is possible because the treatment vibration is imperceptible. Evaluation will be performed at baseline, 2, 4, and 6 weeks of therapy, and 1 month after. Aim 1: To determine clinical potential of TheraBracelet in improving hand functional recovery. Hypothesis: Improvement of hand motor function will be greater for the treatment than control. Hand function will be assessed using the Wolf Motor Function, Box and Block, and Action Research Arm Tests, along with the quantity/quality of the upper limb use in daily living, abilities for daily activities, and participant feedback. Aim 2: To determine the effects of TheraBracelet on sensorimotor grip control and neural communication. Hypothesis: The treatment will enhance sensorimotor grip control and neural communication for hand grip compared with control. Sensorimotor grip control will be assessed using the well-established biomechanical measure of digit force directional control and efficient scaling of grip force during grip-and-lift. Neural communication for hand grip will be quantified as increase in EEG coherence in the cortical sensorimotor network for grip compared to rest. Secondary analyses will include characterizing the time course of effects and responder analysis. Impact: This research will determine clinical utility and biomarkers of this novel stimulation to guide potential translation. This research is translational as this stimulation is implemented in an aesthetically appealing smartwatch, does not interfere with hand motion, and can be easily integrated in clinical practice. Enhancing hand function should substantially increase stroke survivors' independence and quality of life, and reduce caregiver burden.