Department of Speech Pathology, Audiology and Orthoptics, School of Allied Health, La Trobe University, Melbourne, Australia.
Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.
Int J Stroke. 2019 Dec;14(9):972-976. doi: 10.1177/1747493019870401. Epub 2019 Sep 7.
The comparative efficacy and cost-effectiveness of constraint-induced and multi-modality aphasia therapy in chronic stroke are unknown.
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.
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.
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).
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.
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.
约束诱导疗法和多模态失语症疗法治疗慢性脑卒中的疗效和成本效益比较尚不清楚。
在 COMPARE 试验中，我们旨在确定多模态失语症治疗（M-MAT）和强制性诱导失语症治疗加（CIAT-Plus）是否优于慢性卒中后失语症的常规护理（UC）。主要假设：CIAT-Plus 和 M-MAT 与 UC 相比，将降低失语症严重程度（西部失语症成套测验修订版失语症商数（WAB-R-AQ））：CIAT-Plus 对中度失语症更有效；M-MAT 对轻度和重度失语症更有效。
共有 216 名参与者（每组 72 名）将在 α = 0.05 时提供 90%的效力，以检测 CIAT-Plus 或 M-MAT 与 UC 之间 WAB-R-AQ 差异 5 分。
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；失语症严重程度采用 WAB-R-AQ 进行分类。根据 WAB-R-AQ 严重程度（轻度、中度和重度），使用计算机生成的块和分层随机分组，分为 3 组：CIAT-Plus、M-MAT（均为 2 周内 30 小时治疗）；UC（自我报告的常规社区护理）。
干预后即刻 WAB-R-AQ。次要结果：12 周随访时 WAB-R-AQ；命名评分、话语测量、交际效果指数、情景测试和中风和失语症生活质量量表-39g 即刻和干预后 12 周；与 UC 相比，12 周时的增量成本效益比。
该试验将确定 CIAT-Plus 和 M-MAT 是否优于 UC，在慢性失语症中更有效且更具成本效益。将描述对 CIAT-Plus 和 M-MAT 反应最大的参与者亚组。
