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

对侧控制 FES 治疗慢性手臂/手偏瘫：单部位随机对照试验

基本信息

批准号：
7756673
负责人：
Jayme S. Knutson
金额：
$ 44.78万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-01-10 至 2013-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7756673
关键词：
Activities of Daily Living Affect Alternative Therapies Animals Bilateral Chronic Clinical Research Contralateral Control Groups Coupling Development Disabled Persons Dose Effectiveness Electric Stimulation Electrodes Environment FPS-FES Oncogene Fingers Funding Goals Hand Hand functions Health Healthcare Hemiplegia Impairment Individual Intention Intervention Lead Learning Limb structure Link Measurable Motor Motor output Movement Muscle Occupational Therapy Paralysed Patients Pilot Projects Population Prevalence Principal Investigator Randomized Randomized Clinical Trials Randomized Controlled Trials Recovery Rehabilitation therapy Research Project Grants Severities Site Solid Stimulus Stroke Study Section Surface Survivors Techniques Testing Therapeutic Thumb structure Time Training Treatment Efficacy United States Upper Extremity Work arm chronic stroke design disability effective therapy follow-up functional improvement functional restoration hemiparesis instrument motor impairment neuromuscular novel post stroke public health relevance sensory feedback stroke rehabilitation therapy design therapy development time interval treatment duration treatment effect treatment response upper limb hemiparesis

项目摘要

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.

描述（由申请人提供）：上肢的偏瘫是中风最严重，最常见的障碍之一。在美国，每年发生的75万超过750,000次中风中约有75％引起一定程度的上肢麻痹。大约65％的中风幸存者仍然无法使用受影响的手来协助他们中风后6个月的日常生活活动。上肢障碍对残疾和健康的影响很大，但是旨在恢复上肢受损的功能的康复干预措施相对较少。因此，我们的长期目标是开发有效恢复手臂和手部功能的上肢康复疗法，这些疗法适用于广泛的障碍严重程度，并且在当前的医疗保健环境中很容易实施。这项研究的目的是估计对侧控制功能刺激（CCFE）在减少上肢障碍和慢性上肢偏瘫的活动限制方面的疗效。 CCFES是一种康复干预措施，其中神经肌肉电刺激（NMES）应用于手指和拇指的伸肌肌肉肌肉的上肢，以张开手。中风幸存者通过调节对侧未损坏的手的打开程度来控制刺激强度和随之而来的开放程度，该手套被仪器手套检测到。因此，未受影响的手的自愿开口会产生受影响的手的刺激性开口。刺激范式用于帮助中风幸存者用受影响的手来实践功能任务。慢性偏瘫中CCFE的试点研究令人鼓舞。该项目将扩大已经开始的工作：1）确定CCFEs在慢性中风幸存者中是否有效是否有效，2）确定是否在完成12周之前确定治疗效果是否达到平稳，3）确定初始运动水平如何影响治疗功效，以及4）确定治疗方法是否持续持续时间。我们将进行一项随机对照试验，其中102个慢性中风幸存者（击球后> 6个月）将被随机分配，以接收12周的CCFE或CYCLIC NME，这种干预措施可提供对手动延伸器的电刺激，但具有预编程的时正时和强度。随机分组将在两个基线手动损伤的两个级别分层，这些障碍是由自愿性手指伸展的程度定义的。在治疗期间，每3周以及在6个月的随访期内每3周进行一次评估上肢障碍和活动限制的评估。这项研究是慢性上肢偏瘫中CCFE的首次随机对照试验。最终，本研究中学到的信息将有助于加速减少势后残疾的治疗方法。公共卫生相关性需要对中风残疾的个人进行有效的康复干预措施。这项研究是迈向开发新疗法的重要一步，该方法可能在促进持久运动恢复方面更有效，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发展，势后残疾的患病率可能会降低。