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最严重和最常见的后果之一。美国每年发生超过 795,000 例中风，其中大约 75% 会导致某种程度的上肢急性瘫痪。中风后 6 个月，估计 65% 的患者仍无法将受损的手臂和手纳入日常活动，近三分之一的患者上肢功能慢性丧失，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，我们的长期目标是开发针对瘫痪上肢的康复疗法，并在有效性、适用性和实施​​方面进行优化。对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，用于改善中风后手部功能的恢复。 CCFES 刺激瘫痪手张开，其张开程度与对侧未受损手的有意识张开程度成比例。这使得中风幸存者能够用瘫痪的手执行主动重复的张手练习、手部运动控制任务和功能性任务。在这项研究中，我们添加了对侧肘部控制的肘部伸肌的刺激，以提高伸展范围和手的张开度。本研究的目的是通过增加肘部伸展刺激、增加和评估治疗持续时间的效果以及估计中风后开始治疗的最佳时间来优化 CCFES。具体目标包括：1) 评估手臂+手 CCFES 对上肢运动障碍和活动限制的影响，2) 评估治疗持续时间的影响，3) 确定治疗效果与中风发作和开始治疗之间的时间之间的关系。一百八 (108) 名患有急性/亚急性（中风后≤ 6 个月）上肢偏瘫的中风幸存者将被按相同比例随机分配接受 6、9 或 12 周的手臂+手 CCFES 或 12 周的循环 NMES，这是一种刺激肘部和手伸展的干预措施，但时间和强度预设。将在基线、第 6、9、12、20、28 和 36 周时评估上肢损伤和活动限制。通过优化针对急性中风幸存者的CCFES治疗，其治疗效果将最大化，并且将估计最佳治疗持续时间和开始治疗的时间范围。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传播减少中风后残疾的新疗法。