Interdisciplinary Comprehensive Arm Rehab Evaluation (I-CARE) Stroke

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，单盲， 多中心随机对照试验研究ASAP(加速技能)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觉 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。

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, singleblind, 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.