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: 8236177
• 负责人: Jayme S. Knutson
• 金额: $ 38.46万
• 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/8236177
• 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. PUBLIC HEALTH RELEVANCE: There is a need for more effective motor 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 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 and administered during the acute recovery phase, the prevalence of chronic post-stroke disability may be decreased.

描述（由申请人提供）：手臂和手部功能受损是中风最常见的致残后果之一。在美国每年发生的超过795，000次中风中，约75%会引起一定程度的急性上肢瘫痪。到中风后6个月，估计65%的患者仍然不能将受损的手臂和手纳入日常活动中，近三分之一的患者患有上肢功能的慢性丧失，其特征通常是无法伸展手臂和张开手。虽然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，我们的长期目标是为瘫痪上肢开发有效性、适用性和实施方面最优化的康复疗法。双侧控制功能性电刺激（CCFES）是一种创新的神经肌肉电刺激（NMES）治疗方法，用于改善中风后手功能的恢复。CCFES刺激麻痹的手打开的程度成比例的对侧未受损的手的意志开放。这使得中风幸存者能够用麻痹的手进行主动重复的手部张开练习、手部运动控制任务和功能性任务。在这项研究中，我们增加了由对侧肘控制的肘伸肌的刺激，以改善伸展和手的张开。本研究的目的是通过增加刺激伸肘、增加和评估治疗持续时间的效果以及估计卒中后开始治疗的最佳时间来优化CCFES。具体目标包括：1）估计手臂+手CCFES对上肢运动障碍和活动受限的影响，2）估计治疗持续时间的影响，3）定义治疗效果与卒中发作和治疗开始之间的时间之间的关系。将108例急性/亚急性（卒中后6个月）上肢偏瘫的卒中幸存者以相等比例随机分配接受6、9或12周的臂+手CCFES或12周的周期性NMES，这是一种刺激手肘和手伸展的干预，但具有预设的时间和强度。将在基线、第6、9、12、20、28和36周评估上肢损伤和活动受限。通过优化急性卒中幸存者的CCFES治疗，其治疗效果将最大化，并将估计最佳治疗持续时间和开始治疗的时间表。这些信息对于设计Arm+Hand CCFES的大规模疗效试验至关重要，并将有助于加速开发并最终推广减少卒中后残疾的新治疗方法。 公共卫生相关性：需要对因中风致残的个人进行更有效的运动康复干预。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治疗的开发和管理在急性恢复期，慢性中风后残疾的患病率可能会下降。