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

项目总结/摘要 中风后的残余残疾是相当大的，约65%的患者在6个月时不能将 有效地将麻痹的手纳入日常活动中。反过来，这种程度的功能缺陷有助于减少 中风后的生活质量I-CARE的主要目标（跨学科综合手臂康复） 评估）是为了改善中风后手臂麻痹的门诊治疗。我们将进行第三阶段，单一- 研究ASAP（加速技能）有效性的盲法、多中心、随机对照试验 收购计划），一个集中的，密集的，循证的，上肢康复计划。ASAP 结合了约束诱导疗法、基于技能/减轻损伤的特定任务训练， 嵌入式激励增强，包括30小时的一对一治疗，在早期 卒中后急性期后门诊间隔（1-3个月）。 这项随机对照试验有一个主要目的：将ASAP与剂量等效的常规和习惯职业 治疗（高剂量）组。有两个次要目标：a）将ASAP与真实（仅监测）常规进行比较 B）常规治疗组（低剂量组）与常规治疗组（高剂量组）比较 治疗组改为小剂量常规作业治疗组。 我们将随机抽取360名中风发作后1 - 3个月内的成年人， 肢体损伤我们的主要结果是基于表现的手臂功能测试，Wolf运动功能 参加后一年进行测试（WMFT）。次要结果包括患者对麻痹的自我感觉 手功能，中风影响量表（SIS）的一个领域和完整的SIS。特定亚组分析将 探索重要的调节因素，包括发病时间、卒中类型和运动障碍。 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 提供在批准的治疗次数内最佳分配治疗服务的证据 会议将减少残疾，减轻社会负担，并提供一个标准化的循证医学。 治疗有用的康复临床医生和未来的临床试验。项目叙述： 跨学科综合手臂康复评估（I-CARE）中风倡议试验实施 2006年NINDS卒中进展审查小组的报告确定了卒中恢复的优先事项， 康复研究。I-CARE是一项随机对照试验，将测试传统康复的重要参数 干预措施包括：时机、给药方案、治疗效应的半衰期和 各种训练模式。如果我们的主要假设得到支持，这项III期试验将改变目前的 在急性期后门诊治疗期间对轻度至中度手臂和 手部损伤我们的次要假设同样重要：将高治疗剂量与低治疗剂量进行比较， 通常提供的剂量将决定单独的剂量是否影响功能结果。I-CARE的调查结果将 建立基于证据的门诊手臂治疗的内容和访问次数的建议 必须优化结果。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、干细胞植入和直接皮层刺激。

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.