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

• 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
• 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

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）：上肢偏瘫是中风引起的最严重和最常见的损伤之一。美国每年发生超过 750,000 起中风，其中大约 75% 会导致某种程度的上肢瘫痪。大约 65% 的中风幸存者在中风后 6 个月仍然无法使用受影响的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措施相对较少。因此，我们的长期目标是开发上肢康复疗法，能够有效恢复手臂和手部功能，适用于各种损伤严重程度，并且易于在当前的医疗环境中实施。本研究的目的是评估对侧控制功能性电刺激 (CCFES) 在减少慢性上肢偏瘫的上肢损伤和活动限制方面的功效。 CCFES 是一种康复干预，其中神经肌肉电刺激 (NMES) 应用于瘫痪上肢的手指和拇指伸肌以张开手。中风幸存者通过调节对侧未受损手的张开程度（由仪器手套检测）来控制刺激强度以及随之而来的手部张开程度。因此，未受影响的手的自愿张开会刺激受影响的手的张开。刺激范例用于帮助中风幸存者用受影响的手练习功能性任务。 CCFES 在慢性偏瘫中的初步研究令人鼓舞。该项目将通过以下方式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) 确定在 12 周完成之前治疗效果是否达到平台期，3) 确定运动障碍的初始水平如何影响治疗效果，以及 4) 确定治疗效果是否随着时间的推移持续存在。我们将进行一项随机对照试验，其中 102 名慢性中风幸存者（中风后 6 个月以上）将被随机分配接受为期 12 周的 CCFES 或循环 NMES，这是一种对手伸肌提供电刺激的干预措施，但时间和强度均预先设定。随机化将根据手部基线损伤的两个水平进行分层，这两个水平由手指自愿伸展的程度定义。治疗期间每 3 周进行一次上肢损伤和活动限制评估，在 6 个月的随访期间每 2 个月进行一次上肢损伤和活动限制评估。本研究是第一个CCFES治疗慢性上肢偏瘫的随机对照试验。最终，本研究中学到的信息将有助于加速减少中风后残疾的治疗方法的开发。 公共卫生相关性 对于因中风致残的个人需要有效的康复干预措施。这项研究是开发新疗法的重要一步，可能会发现这种新疗法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开发，中风后残疾的患病率可能会降低。