Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia

优化对侧控制 FES 治疗急性上肢偏瘫

• 批准号: 8692438
• 负责人: Jayme S. Knutson
• 金额: $ 41.81万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8692438
• 关键词: Acute; Affect; American; Animals; Bilateral; Brain; Characteristics; Chronic; Clinical Research; Contralateral; Coupling; Data; Development; Disabled Persons; Effectiveness; Elbow; Electric Stimulation; Electrodes; Exercise; FPS-FES Oncogene; Fingers; Hand; Hand functions; Health; Hemiplegia; Impairment; Individual; Injury; Intention; Intervention; Lead; Learning; Limb structure; Link; Modeling; Motor; Motor Activity; Motor output; Movement; Muscle; Outcome; Paralysed; Participant; Patients; Phase; Pilot Projects; Prevalence; Randomized; Recovery; Recurrence; Regimen; Rehabilitation therapy; Scheme; Stimulus; Stroke; Surface; Survivors; Techniques; Therapeutic Effect; Thumb structure; Time; United States; Upper Extremity; acute stroke; arm; clinical efficacy; design; disability; efficacy trial; functional restoration; improved; innovation; motor control; motor impairment; neuromuscular; novel; post stroke; programs; sensory feedback; stroke rehabilitation; technology/technique; therapy design; treatment duration; treatment effect

DESCRIPTION (provided by applicant): Impaired arm and hand function is one of the most disabling and most common consequences of stroke. Approximately 75% of the over 795,000 strokes that occur annually in the Unites States cause some degree of upper limb paralysis acutely. By 6 months post-stroke an estimated 65% of patients still cannot incorporate the impaired arm and hand into their daily activities, and nearly one third have chronic loss of upper limb function, which is often characterized by inability to extend the arm and open the hand. While the impact of upper limb impairments on disability and health is great, there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop rehabilitation therapies for the paretic upper limb that are optimized for effectiveness, applicability, and implementation. Contralaterally Controlled Functional Electrical Stimulation (CCFES) is an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke. CCFES stimulates the paretic hand to open in proportion to the degree of volitional opening of the contralateral unimpaired hand. This enables the stroke survivor to perform active repetitive hand opening exercises, hand motor-control tasks, and functional tasks with the paretic hand. In this study, we add stimulation of elbow extensors controlled by the contralateral elbow in order to improve reach as well as hand opening. The purpose of this study is to optimize CCFES by adding stimulated elbow extension, increasing and evaluating the effect of treatment duration, and estimating the best time after stroke to begin treatment. The specific aims include: 1) estimating the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation, 2) estimating the effect of treatment duration, 3) defining the relationship between treatment effect and time elapsed between stroke onset and start of treatment. One hundred eight (108) stroke survivors with acute/subacute (≤ 6 months post-stroke) upper limb hemiplegia will be randomly assigned in equal proportions to receive either 6, 9, or 12 weeks of Arm+Hand CCFES or 12 weeks of cyclic NMES, which is an intervention that stimulates the elbow and hand to extend, but with pre-set timing and intensity. Upper limb impairment and activity limitation will be assessed at baseline, 6, 9, 12, 20, 28, and 36 weeks. By optimizing the CCFES treatment for acute stroke survivors, its therapeutic effect will be maximized and the optimum treatment duration and timeframe to start treatment will be estimated. This information is critical for the design of a large-scale efficacy trial of Arm+Hand CCFES, and will serve to accelerate the development and ultimately the dissemination of a new treatment for reducing post-stroke disability.

描述（由申请人提供）：手臂和手部功能受损是中风的最残疾和最常见的后果之一。每年在联合状态中发生的795,000多个中风中，大约有75％引起一定程度的上肢瘫痪。触球后6个月，估计有65％的患者仍无法将受损的手臂和手纳入他们的日常活动，而将近三分之一的患者患有上肢功能的长期丧失，通常其特征是无法伸出手臂并张开手。尽管上肢损害对残疾和健康的影响很大，但旨在恢复上肢受损的功能的康复干预措施相对较少。因此，我们的长期目标是针对针对有效性，适用性和实施​​而优化的副上肢开发康复疗法。对侧控制功能电刺激（CCFE）是一种创新的神经肌肉电刺激（NMES）治疗，用于改善中风后手功能的恢复。 CCFE与对侧未损坏的手的自愿性开放程度成比例地刺激了偏心的手。这使中风幸存者能够用副手执行主动重复的手开练习，手动​​控制任务以及功能性任务。在这项研究中，我们添加了对对侧肘部控制的肘伸肌的刺激，以提高覆盖范围和手势。这项研究的目的是通过添加刺激的肘部扩展，增加和评估治疗持续时间的效果，并估算中风后开始治疗的最佳时间来优化CCFE。具体目的包括：1）估计ARM+手动CCF对上肢运动障碍和活动限制的影响，2）估计治疗持续时间的影响，3）定义治疗效果与中风开始和治疗开始之间经过的时间之间的关系。具有急性/亚急性（中风后≤6个月）上肢倾斜的一百八（108）个中风幸存者将以相等比例的比例随机分配，以接收6、9或12周的ARM+手动CCF或12周的环状NME，这是刺激肘部和手柄的介入，但要延伸到肘部和预定的时间。上肢损伤和活动限制将在基线，6、9、12、20、28和36周时评估。通过优化急性中风幸存者的CCFE治疗，将最大程度地提高其治疗效果，并估计最佳的治疗持续时间和时间范围。此信息对于设计ARM+手动CCFE的大规模疗效试验至关重要，并且将有助于加速发展，并最终传播新的治疗方法，以减少冲程后残疾。