Interdisciplinary Comprehensive Arm Rehab Evaluation (I-CARE) Stroke

跨学科综合手臂康复评估 (I-CARE) 中风

• 批准号: 8115809
• 负责人: Carolee J Winstein
• 金额: $ 292.13万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8115809
• 关键词: Acute; Address; Adult; Aftercare; Bilateral; Caring; Chronic Phase; Clinical; Clinical Trials; Community Trial; Complex; Development; Dose; Effectiveness; Elements; Environment; Evaluation; Evidence based treatment; Exercise; Family; Future; Gait; Goals; Hand; Hand functions; Home environment; Hour; Household; Hybrids; Impairment; Inpatients; Intervention; Kinesiology; Laboratories; Learning; Leg; Leisure Activities; Level of Evidence; Limb structure; Lower Extremity; Masks; Measures; Medicare; Modality; Monitor; Motor; Movement; Occupational Therapy; Outcome Measure; Outpatients; Paresis; Participant; Patient Self-Report; Patients; Performance; Phase; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Recovery; Recovery of Function; Rehabilitation therapy; Residual state; Resolution; Reversal Learning; Secondary to; Self Care; Self Perception; Services; Site; Solutions; Stroke; Subgroup; Testing; Time; Training; Translations; Travel; Upper Extremity; Walking; Wolves; abstracting; acute stroke; arm; base; comparative efficacy; constraint induced therapy; cost; design; disability; effective intervention; evidence base; 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 as usual; 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, 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.

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），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 治疗组（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）。次要结局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。