RATIONALE The comparative efficacy and cost-effectiveness of constraint-induced and multi-modality aphasia therapy in chronic stroke are unknown. AIMS AND HYPOTHESES In the COMPARE trial, we aim to determine whether Multi-Modal Aphasia Treatment (M-MAT) and Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) are superior to usual care (UC) for chronic post-stroke aphasia. Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia. SAMPLE SIZE ESTIMATES A total of 216 participants (72 per arm) will provide 90% power to detect a 5-point difference on the WAB-R-AQ between CIAT-Plus or M-MAT and UC at α = 0.05. METHODS AND DESIGN Prospective, randomized, parallel group, open-label, assessor blinded trial. Participants: Stroke >6 months; aphasia severity categorized using WAB-R-AQ. Computer-generated blocked and stratified randomization by aphasia severity (mild, moderate, and severe), to 3 arms: CIAT-Plus, M-MAT (both 30 h therapy over two weeks); UC (self-reported usual community care). STUDY OUTCOMES WAB-R-AQ immediately post-intervention. Secondary outcomes: WAB-R-AQ at 12-week follow-up; naming scores, discourse measures, Communicative Effectiveness Index, Scenario Test, and Stroke and Aphasia Quality of Life Scale-39 g immediately and at 12 weeks post-intervention; incremental cost-effectiveness ratios compared with UC at 12 weeks. DISCUSSION This trial will determine whether CIAT-Plus and M-MAT are superior and more cost-effective than UC in chronic aphasia. Participant subgroups with the greatest response to CIAT-Plus and M-MAT will be described.

中文翻译：

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约束诱导或多模式个性化失语康复（COMPARE）：一项针对中风相关慢性失语症的随机对照试验。


基本原理 约束诱导失语症治疗和多模式失语症治疗对慢性卒中的比较疗效和成本效益尚不清楚。目的和假设 在 COMPARE 试验中，我们的目的是确定多模式失语治疗 (M-MAT) 和约束性失语治疗加 (CIAT-Plus) 对于慢性中风后失语是否优于常规护理 (UC)。主要假设：与 UC 相比，CIAT-Plus 和 M-MAT 将降低失语症严重程度（西方失语症电池修正失语商数 (WAB-R-AQ)）：CIAT-Plus 对于中度失语症更有效； M-MAT 对于轻度和重度失语症更有效。样本量估计 总共 216 名参与者（每组 72 名）将提供 90% 的功效来检测 CIAT-Plus 或 M-MAT 与 UC 之间的 WAB-R-AQ 5 点差异（α = 0.05）。方法和设计 前瞻性、随机、平行组、开放标签、评估者盲法试验。参与者：中风>6个月；使用 WAB-R-AQ 对失语症严重程度进行分类。计算机生成的按失语严重程度（轻度、中度和重度）进行分组和分层随机化，分为 3 个组：CIAT-Plus、M-MAT（均为两周内 30 小时的治疗）； UC（自我报告的常规社区护理）。干预后立即研究结果 WAB-R-AQ。次要结局：12 周随访时的 WAB-R-AQ；命名分数、话语测量、沟通有效性指数、情景测试以及中风和失语症生活质量量表 - 干预后立即和 12 周时 39 g；与 12 周时的 UC 相比，增量成本效益比。讨论 本试验将确定 CIAT-Plus 和 M-MAT 在治疗慢性失语症方面是否比 UC 更优越且更具成本效益。将描述对 CIAT-Plus 和 M-MAT 反应最大的参与者亚组。