Interdisciplinary Comprehensive Arm Rehab Evaluation (I-CARE) Stroke Initiative

跨学科综合手臂康复评估 (I-CARE) 中风倡议

• 批准号: 7905229
• 负责人: Alexander W Dromerick
• 金额: $ 12.84万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7905229
• 关键词: Acute; Address; Adult; Aftercare; Bilateral; Caring; Chronic Phase; Classification; Clinical; Clinical Trials; Community Trial; Complex; Development; Dose; Effectiveness; Elements; Environment; Evaluation; Evidence based treatment; Exercise; Family; Future; Gait; Gene Therapy Agent; Goals; Half-Life; Hand; Hand functions; Home environment; Hour; Household; Hybrids; Impairment; Implant; Inpatients; Intervention; Kinesiology; Laboratories; Learning; Leg; Leisure Activities; Level of Evidence; Limb structure; Lower Extremity; Masks; Measures; Medicare; Modality; Monitor; Motor; Movement; National Institute of Neurological Disorders and Stroke; Neurorehabilitation; Occupational Therapy; Outcome; Outpatients; Paresis; Participant; Patient Self-Report; Patients; Performance; Phase; Phase III Clinical Trials; Progress Review Group; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Recovery; Recovery of Function; Rehabilitation Research; Rehabilitation therapy; Reporting; Residual state; Resolution; Reversal Learning; Schedule; Secondary to; Self Care; Self Perception; Services; Site; Solutions; Stem cells; Stroke; Subgroup; Testing; Time; Training; Translations; Travel; Upper Extremity; Upper arm; Visit; Walking; Wolves; abstracting; acute stroke; base; blind; comparative efficacy; constraint induced therapy; cost; design; disability; effective intervention; evidence base; evidence based guidelines; experience; functional outcomes; improved; instrument; motor control; motor impairment; motor learning; muscle strength; post intervention; post stroke; primary outcome; programs; remediation; secondary outcome; skill acquisition; skills; stroke recovery; stroke rehabilitation; systematic review; tool; treatment effect; trend

Project Summary/Abstract Residual disability after stroke is substantial, with about 65% of patients at 6 months unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The primary objective of I-CARE (Interdisciplinary Comprehensive Arm Rehabilitation Evaluation) is to improve outpatient therapy for arm paresis after stroke. We will conduct a Phase III, single- blind, multi-center, randomized control trial to investigate the effectiveness of ASAP (Accelerated Skill Acquisition Program), a focused, intense, evidence-based, upper extremity rehabilitation program. ASAP combines aspects of constraint-induced therapy, skill-based/impairment-mitigating task-specific training with embedded motivational enhancements and includes 30 hours of one-on-one therapy initiated during the early post-acute outpatient interval (1-3 months) after stroke. This RCT has one primary aim: Compare ASAP to a dose equivalent usual and customary occupational therapy (high dose) group. There are two secondary aims: a) Compare ASAP to a true (monitoring only) usual and customary therapy group (low dose) and b) Compare the high dose usual and customary occupational therapy group to the low dose usual and customary occupational therapy group. We will randomize 360 adults, within one to three months of stroke onset, with mild to moderate upper extremity impairment. Our primary outcome is a performance-based arm function test, Wolf Motor Function Test (WMFT) at one year after participation. Secondary outcomes include patients' self-perception of paretic hand function, a domain of the Stroke Impact Scale (SIS) and the full SIS. Specific subgroup analyses will explore important moderating factors including duration from onset, stroke type, and motor impairment. Given the trend toward diminished total reimbursable time for stroke rehabilitation, our ultimate goal is to provide evidence toward an optimal allocation of therapy services within the approved number of treatment sessions that will reduce disability, lessen the societal burden, and provide a standardized evidence-based treatment useful for the rehabilitation clinician and future clinical trialist. Project Narrative: The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (I-CARE) Stroke Initiative trial implements the 2006 Report of the NINDS Stroke Progress Review Group's established priorities for stroke recovery and rehabilitation research. I-CARE is an RCT that will test ¿important parameters of conventional rehabilitation interventions including: timing, dosing schedule, half life of treatment effect, and (the) differential effects of various training paradigms¿. If our primary hypothesis is supported, this Phase III trial would change current neurorehabilitation treatment during post-acute outpatient therapy for those with mild to moderate arm and hand impairments. Our secondary hypothesis is equally important: comparing a high therapy dose to the lower dose usually provided will determine if dose alone impacts functional outcomes. The findings of I-CARE will establish evidence-based recommendations for the content of outpatient arm therapy and the number of visits necessary to optimize outcome. Further, I-CARE will generate two standardized outpatient neurorehabilitation protocols that can be used in trials of current and future experimental interventions such as pharmacological agents, gene therapy, stem cell implants, and direct cortical stimulation.

项目摘要/摘要 中风后的残废是很严重的，大约65%的患者在6个月时无法合并 麻木的手有效地融入日常活动。反过来，这种程度的功能性赤字有助于减少 中风后的生活质量。I-CARE(跨学科综合手臂康复)的主要目标 评估)是改善中风后手臂瘫痪的门诊治疗。我们将进行第三阶段，单一- 盲法、多中心、随机对照试验研究ASAP(加速技术)的有效性 收购计划)，这是一个专注、紧张、以证据为基础的上肢康复计划。尽快 将约束性诱导治疗、基于技能/减轻损伤的特定任务培训与 嵌入式激励增强，包括在早期开始的30小时一对一治疗 卒中后急性门诊间隔(1-3个月)。 这项随机对照试验有一个主要目标：尽快与通常和习惯职业的剂量当量进行比较。 治疗(高剂量)组。有两个次要目标：a)尽快与真实的(仅限监测)进行比较 和常规治疗组(低剂量)和b)比较大剂量常规和常规职业 治疗组改为常规小剂量常规作业治疗组。 我们将在中风发作的一到三个月内随机选择360名患有轻度到中度上半身中风的成年人 四肢损伤。我们的主要结果是基于性能的手臂功能测试，即Wolf运动功能 在参与一年后进行WMFT测试。次要结果包括患者对轻瘫的自我感知 手功能，卒中影响量表(SIS)的一个领域和完整的SIS。特定的子组分析将 探索重要的调节因素，包括发病持续时间、中风类型和运动障碍。 考虑到中风康复的总可报销时间减少的趋势，我们的最终目标是 在批准的治疗次数内提供最佳治疗服务分配的证据 会议将减少残疾，减轻社会负担，并提供标准化的循证 治疗对康复临床医生和未来的临床试用者有用。项目说明： 跨学科综合手臂康复评估(I-CARE)卒中倡议试验实施 NINDS卒中进展审查小组2006年的报告确定了卒中恢复和治疗的优先事项 康复研究。I-CARE是一种RCT，它将测试传统康复的重要参数 干预措施包括：时间安排、给药时间表、治疗半衰期效应和不同的药物效应。 不同的培训模式。如果我们的主要假设得到支持，这项第三阶段试验将改变目前的情况 轻、中度臂丛神经功能障碍患者急性门诊治疗期间的神经康复治疗 手部损伤。我们的第二个假设同样重要：比较高治疗剂量和低治疗剂量 通常提供的剂量将决定剂量是否单独影响功能结果。I-care的调查结果将 为门诊手臂治疗的内容和就诊次数建立循证建议 这是优化结果所必需的。此外，i-care将产生两个标准化的门诊神经康复 可用于当前和未来实验干预试验的方案，如药理学 药物、基因治疗、干细胞移植和直接皮质刺激。