Contralaterally Controlled FES versus Cyclic NMES for Hand Function after Stroke

项目摘要/摘要 中风康复技术和治疗必须通过多个阶段的研究取得进展 并在它们达到临床接受并转化为临床实践之前进行开发。从 单站点到多站点的临床试验是这一过程中的关键一步。多个地点的研究证明 技术和/或治疗可由始发地点以外的地点成功实施 类似的积极结果。这里提出的这项研究是一种新干预措施的第一次多点临床试验 称为对侧控制功能电刺激(CCFES)。CCFES是一项创新技术 康复治疗对促进上肢患者手功能恢复的作用 偏瘫。CCFES通过对偏瘫手指和拇指伸肌进行电刺激 表面电极，导致虚弱的手张开，这是中风幸存者经常失去的功能。病人 通过在未受影响的手上戴上带有传感器的手套来控制对其瘫痪手的刺激强度 另一只手。当患者张开未受影响的手时，刺激强度成比例地打开。 他们那双麻木的手。CCFES使患者重新控制他们瘫痪的手，这可能会驱动神经整形 导致手功能更好恢复的变化。CCFES疗法包括使用该设备辅助手部 在实验室与治疗师进行功能任务练习期间开放，并自行管理CCFES- 居家介入性重复张手练习。我们之前的单点研究表明，CCFES 在慢性(6个月)中风患者中，比传统的循环式NMES(CNMES)更能提高灵活性，并且 确定最有可能的应答者是中风后不到2年的中风幸存者。主 这项研究的目的是证实和论证这些初步结果在更大范围内的普适性 跨多个站点的一组最有可能的响应者。这项研究将招募171名中风幸存者，年龄在6岁到24岁之间 中风后几个月。他们将随机接受为期12周的CCFES，cNMES(应用电学 刺激手部伸肌，但有预先设定的时间和强度)，或没有任务导向的训练 电刺激。这项研究将由三个地点的研究小组进行，他们将管理 治疗和盲目的结果评估。这项研究将确定CCFES治疗是否会产生 在上肢功能方面比cNMES或任务导向训练有更大的改善，并探讨其效果 CCFES治疗对中枢神经系统的影响。改进的保留将通过6- 治疗后一个月的随访期。这项第二阶段的多地点研究是推进一项新的 康复方法走向临床翻译并广泛传播。

PROJECT SUMMARY/ABSTRACT Stroke rehabilitation technologies and treatments must progress through multiple phases of research and development before they reach clinical acceptance and are translated to clinical practice. Progressing from single-site to multi-site clinical trials is a critical step in the process. Multi-site studies prove whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positive outcomes. The study proposed here is the first multi-site clinical trial of a new intervention called contralaterally controlled functional electrical stimulation (CCFES). CCFES is an innovative technology and rehabilitation therapy for improving the recovery of hand function in patients with upper extremity hemiparesis. CCFES applies electrical stimulation to the paretic finger and thumb extensor muscles through surface electrodes, causing the weak hand to open, a function that is often lost in stroke survivors. The patient controls the intensity of stimulation to their paretic hand by wearing a glove with sensors on their unaffected contralateral hand. When the patient opens their unaffected hand, a proportional intensity of stimulation opens their paretic hand. CCFES puts the patient back in control of their paretic hand, and this may drive neuroplastic changes that lead to better recovery of hand function. CCFES therapy includes using the device to assist hand opening during functional task practice sessions with a therapist in the lab plus self-administering a CCFES- mediated repetitive hand opening exercise at home. Our previous single-site study showed that CCFES improves dexterity more than conventional cyclic NMES (cNMES) in chronic (> 6 months) stroke patients, and identified most likely responders to be stroke survivors who are less than 2 years post-stroke. The main purpose of this study is to confirm and demonstrate the generalizability of these preliminary results in a larger group of most likely responders across multiple sites. The study will enroll 171 stroke survivors who are 6 to 24 months post-stroke. They will be randomized to 12 weeks of CCFES, cNMES (which applies electrical stimulation to the hand extensors, but with pre-set timing and intensity), or task-oriented training without electrical stimulation. The study will be conducted by research teams at three sites, who will administer the treatments and blinded outcome assessments. This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or task-oriented training, and explore the effects of CCFES therapy on the central nervous system. Retention of improvements will be evaluated through a 6- month post-treatment follow-up period. This Phase II multi-site study is a critical step in advancing a novel method of rehabilitation toward clinical translation and widespread dissemination.