Contralaterally Controlled FES for Chronic Arm/Hand Hemiplegia: Single-Site RCT

描述(申请人提供)：上肢偏瘫是中风引起的最严重和最常见的损伤之一。在美国每年发生的超过75万例中风中，大约75%会导致不同程度的上肢瘫痪。约65%的卒中幸存者在卒中后6个月仍不能使用患手协助日常生活活动。上肢损伤对残疾和健康的影响很大，但旨在恢复受损上肢功能的康复干预相对较少。因此，我们的长期目标是开发在恢复手臂和手功能方面有效的、适用于各种损伤严重程度的上肢康复疗法，以及在目前的医疗环境中易于实施的上肢康复疗法。本研究的目的是评价对侧控制功能电刺激(CCFES)对减轻慢性上肢偏瘫患者上肢功能损害和活动受限的疗效。CCFES是一种康复干预措施，通过对瘫痪上肢的手指和拇指伸肌进行神经肌肉电刺激(NMES)来打开手。中风幸存者通过调节对侧未受损手的张开程度来控制刺激强度和随之而来的手张开程度，该程度由仪器手套检测。因此，随意张开未受影响的手会刺激受影响的手的张开。刺激范式被用来帮助中风幸存者用他们受累的手练习功能性任务。慢性偏瘫患者CCFES的初步研究令人鼓舞。该项目将扩展已经开始的工作：1)确定12周的CCFES对慢性中风幸存者是否具有治疗效果，2)确定治疗效果是否在12周完成之前达到平台期，3)确定运动障碍的初始水平如何影响治疗效果，以及4)确定治疗成果是否随着时间的推移而持续。我们将进行一项随机对照试验，将102名慢性中风幸存者(中风后6个月)随机分配到接受为期12周的CCFES或周期性NMES，这是一种干预措施，提供手伸肌的电刺激，但具有预先编程的时间和强度。随机化将分为两个水平的基线手损伤，定义为自愿伸指的程度。在治疗期间每3周进行一次上肢损伤和活动受限的评估，并在6个月的随访期内每2个月进行一次评估。这项研究是CCFES治疗慢性上肢偏瘫的第一个随机对照试验。最终，从这项研究中获得的信息将有助于加速开发减少中风后残疾的治疗方法。公共卫生相关性需要对因中风致残的个人进行有效的康复干预。这项研究是朝着开发一种新的治疗方法迈出的重要一步，这种治疗方法可能会被发现更有效地促进持久的运动恢复，更广泛地适用于更广泛的中风幸存者，并且比现有的中风康复技术更容易实施。随着更有效的中风康复疗法的开发，中风后残疾的患病率可能会降低。

DESCRIPTION (provided by applicant): Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately 65% of stroke survivors still cannot use their affected hand to assist with activities of daily living 6 months after their stroke. The impact of upper extremity impairments on disability and health is great, yet there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop upper extremity rehabilitation therapies that are effective at restoring arm and hand function, that are applicable across a wide range of impairment severity, and that are readily implemented in the present healthcare environment. The purpose of this study is to estimate the efficacy of Contralataterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor muscles of the paretic upper limb to open the hand. The stroke survivor controls the stimulation intensity, and consequent degree of hand opening, by modulating the degree of opening of the contralateral unimpaired hand, which is detected by an instrumented glove. Thus, volitional opening of the unaffected hand produces stimulated opening of the affected hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional tasks with their affected hand. Pilot studies of CCFES in chronic hemiplegia were encouraging. This project will expand on the work already begun by: 1) determining if 12 weeks of CCFES is therapeutically effective in chronic stroke survivors, 2) determining if a plateau in treatment effect is achieved before 12 weeks is completed, 3) determining how initial level of motor impairment affects treatment efficacy, and 4) determining whether therapeutic gains persist over time. We will conduct a randomized controlled trial in which 102 chronic stroke survivors (>6 months post-stroke) will be randomly assigned to receive 12 weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified on two levels of baseline hand impairment defined by the degree of voluntary finger extension present. Assessments of upper extremity impairment and activity limitation will be made every 3 weeks during the treatment period and every 2 months during a 6-month follow-up period. This study is the first randomized controlled trial of CCFES in chronic upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability. PUBLIC HEALTH RELEVANCE There is a need for effective rehabilitation interventions for individuals who have become disabled by stroke. This study is an important step toward the development of a new treatment that may be found to be more effective in facilitating lasting motor recovery, more widely applicable to a broader range of stroke survivors, and more readily implemented than existing stroke rehabilitation techniques. As more effective stroke rehabilitation therapies are developed, the prevalence of post-stroke disability may be decreased.