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

描述（由申请人提供）：卒中后的残留残疾是相当大的，约65%的患者在6个月时无法将瘫痪的手有效地纳入日常活动。反过来，这种程度的功能缺陷会导致中风后生活质量下降。I-CARE（跨学科综合手臂康复评估）的主要目标是改善中风后手臂轻瘫的门诊治疗。我们将进行一项III期、单盲、多中心、随机对照试验，以调查ASAP（加速技能获取计划）的有效性，ASAP是一项重点、强化、循证的上肢康复计划。ASAP结合了约束诱导治疗、基于技能/减轻损伤的特定任务培训和嵌入式激励增强的各个方面，包括在卒中后急性期门诊间隔（1-3个月）早期开始的30小时一对一治疗。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）组进行比较。有两个次要目标：a）将ASAP与真实（仅监测）常规和习惯治疗组（低剂量）进行比较，和B）将高剂量常规和习惯职业治疗组与低剂量常规和习惯职业治疗组进行比较。我们将随机选择360名中风发作后1 - 3个月内轻度至中度上肢损伤的成年人。我们的主要结果是在参与后一年进行基于表现的手臂功能测试，Wolf运动功能测试（WMFT）。次要结果包括患者对瘫痪手功能的自我感知，卒中影响量表（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。鉴于卒中康复治疗的总可报销时间减少的趋势，我们的最终目标是提供证据，在批准的治疗次数内优化治疗服务的分配，以减少残疾，减轻社会负担，并为康复临床医生和未来的临床试验提供标准化的循证治疗。

DESCRIPTION (provided by applicant): 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.