Contralaterally Controlled FES versus Cyclic NMES for Hand Function after Stroke

项目总结/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 在达到临床接受并转化为临床实践之前进行开发。取得进展 从单中心到多中心的临床试验是这一过程中的一个关键步骤。多地点研究证明， 技术和/或治疗可以成功地管理的网站以外的起源网站， 类似的积极成果。这里提出的研究是第一个新干预措施的多中心临床试验 称为对侧控制功能性电刺激（CCFES）。CCFES是一项创新技术 康复治疗促进上肢患者手功能的恢复 偏瘫CCFES通过以下方式对麻痹的手指和拇指伸肌施加电刺激： 表面电极，导致虚弱的手打开，中风幸存者往往失去了一个功能。患者 通过在未受影响的手上戴上带有传感器的手套来控制对他们麻痹的手的刺激强度。 对侧的手当患者张开未受影响的手时， 麻痹的手CCFES使患者重新控制麻痹的手，这可能会驱动神经可塑性 这些变化导致手部功能更好的恢复。CCFES治疗包括使用该装置辅助手 在实验室与治疗师进行功能性任务练习期间开放，加上自我管理CCFES- 在家中进行反复的手部张开练习。我们之前的单中心研究表明，CCFES 在慢性（> 6个月）卒中患者中，比常规周期性NMES（cNMES）更能改善灵活性， 确定最可能的反应者是中风后不到2年的中风幸存者。主要 本研究的目的是在一个更大的范围内证实和证明这些初步结果的普遍性。 跨多个站点的最可能响应者组。该研究将招募171名6至24岁的中风幸存者 中风后数月。他们将随机接受12周的CCFES，cNMES（应用电刺激）， 刺激手部伸肌，但具有预先设定的时间和强度），或以任务为导向的训练， 电刺激这项研究将由三个研究中心的研究小组进行，他们将管理 治疗和盲态结局评估。这项研究将确定CCFES治疗是否产生 上肢功能的改善比cNMES或任务导向训练更大，并探讨其效果 CCFES治疗对中枢神经系统的影响。保留改进将通过6- 治疗后1个月随访期。这项II期多中心研究是推进一种新的 康复方法向临床转化和广泛传播。

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.