Contralaterally Controlled FES versus Cyclic NMES for Hand Function after Stroke

对侧控制 FES 与循环 NMES 对中风后手功能的影响

• 批准号: 10226068
• 负责人: Jayme S. Knutson
• 金额: $ 61.06万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10226068
• 关键词: Activities of Daily Living; Affect; Aftercare; Back; Blinded; Brain; Chronic; Clinical; Contralateral; Devices; Dose; Effectiveness; Electric Stimulation; Electric Stimulation Therapy; Electrodes; Enrollment; Exercise; Extensor; FPS-FES Oncogene; Feedback; Fingers; Hand; Hand functions; Home; Impairment; Individual; Intention; Intervention; Lead; Measures; Mediating; Methods; Modality; Motor; Motor Cortex; Movement; Multi-Institutional Clinical Trial; Muscle; Muscle Contraction; Neuraxis; Neuronal Plasticity; Occupational Therapy; Outcome; Outcome Assessment; Output; Paresis; Participant; Patient Outcomes Assessments; Patients; Periodicity; Peripheral; Phase; Process; Randomized; Recovery; Rehabilitation therapy; Research; Sample Size; Self Administration; Site; Stroke; Surface; Technology; Testing; Therapeutic Effect; Thumb structure; Training; Transcranial magnetic stimulation; Translating; United States; Upper Extremity; Volition; arm; clinical efficacy; clinical practice; clinical translation; clinically relevant; clinically significant; cost effective; dexterity; effectiveness evaluation; experience; follow-up; functional electrical stimulation; hand dysfunction; hand rehabilitation; hemiparesis; improved; innovative technologies; instrument; neuromuscular stimulation; novel; novel therapeutics; post stroke; rehabilitation technology; research and development; response; sensor; stroke patient; stroke rehabilitation; stroke survivor

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.

项目概要/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 在获得临床认可并转化为临床实践之前进行开发。进展自 单中心到多中心的临床试验是该过程中的关键步骤。多地点研究证明是否 技术和/或治疗可以在始发地点以外的地点成功实施，并且 类似的积极成果。这里提出的研究是新干预措施的第一个多中心临床试验 称为对侧控制功能性电刺激（CCFES）。 CCFES是一项创新技术 促进上肢患者手功能恢复的康复治疗 偏瘫。 CCFES 通过以下方式对瘫痪手指和拇指伸肌施加电刺激： 表面电极，导致无力的手张开，这种功能在中风幸存者中经常丧失。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瘫痪手的刺激强度 对侧手。当患者张开未受影响的手时，会出现一定比例的刺激强度 他们麻木的手。 CCFES 让患者重新控制瘫痪的手，这可能会促进神经可塑性 导致手部功能更好恢复的变化。 CCFES 疗法包括使用该装置来辅助手 在实验室中与治疗师一起进行功能性任务练习课程期间开始，并自行管理 CCFES- 在家进行重复的张手练习。我们之前的单中心研究表明，CCFES 比传统循环 NMES (cNMES) 更能提高慢性（> 6 个月）中风患者的灵活性，并且 确定最有可能的反应者是中风后不到 2 年的中风幸存者。主要 本研究的目的是确认并证明这些初步结果在更大范围内的普遍性 跨多个站点的最有可能的响应者组。该研究将招募 171 名 6 至 24 岁的中风幸存者 中风后几个月。他们将被随机分配接受为期 12 周的 CCFES、cNMES（应用电气 刺激手伸肌，但有预设的时间和强度），或以任务为导向的训练，无需 电刺激。该研究将由三个地点的研究小组进行，他们将管理 治疗和盲法结果评估。这项研究将确定 CCFES 疗法是否会产生 比 cNMES 或任务导向训练更能改善上肢功能，并探讨其效果 CCFES 疗法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。这项二期多中心研究是推进新型药物的关键一步 康复方法走向临床转化和广泛传播。