Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Victoria, Australia.
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Top Stroke Rehabil. 2024 Jan;31(1):44-56. doi: 10.1080/10749357.2023.2196765. Epub 2023 Apr 10.
High-intensity Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) and Multi-Modality Aphasia Therapy (M-MAT) are effective interventions for chronic post-stroke aphasia but challenging to provide in clinical practice. Providing these interventions may be more feasible at lower intensities, but comparative evidence is lacking. We therefore explored feasibility, acceptability, and preliminary efficacy of the treatments at a lower intensity.
A multisite, single-blinded, randomized Phase II trial was conducted within the Phase III COMPARE trial. Groups of participants with chronic aphasia from the usual care arm of the COMPARE trial were randomized to M-MAT or CIAT-Plus, delivered at the same dose as the COMPARE trial but at lower intensity (6 hours/week × 5 weeks rather than 15 hours/week × 2 weeks). Blinded assessors measured aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient), word retrieval, connected speech, multimodal communication, functional communication, and quality of life immediately post interventions and after 12 weeks. Feasibility and acceptability were explored.
Of 70 eligible participants, 77% consented to the trial; 78% of randomized participants completed intervention and 98% of assessment visits were conducted. Fatigue and distress ratings were low with no related withdrawals. Adverse events related to the trial ( = 4) were mild in severity. Statistically significant treatment effects were demonstrated on word retrieval and functional communication and both interventions were equally effective.
Low-moderateintensity CIAT-Plus and M-MAT were feasible and acceptable. Both interventions show preliminary efficacy at a low-moderate intensity. These results support a powered trial investigating these interventions at a low-moderate intensity.
高强度强制性诱导失语症疗法加(CIAT-Plus)和多模态失语症疗法(M-MAT)是治疗慢性中风后失语症的有效干预措施,但在临床实践中实施起来具有挑战性。降低干预强度可能会提高其实施的可行性,但目前缺乏比较证据。因此,我们在较低强度下探索了这些干预措施的可行性、可接受性和初步疗效。
在 COMPARE 试验的三期研究中进行了一项多中心、单盲、随机二期临床试验。从 COMPARE 试验的常规护理组中招募了患有慢性失语症的参与者,将他们随机分为 M-MAT 或 CIAT-Plus 组,干预强度与 COMPARE 试验相同,但剂量较低(每周 6 小时×5 周,而不是每周 15 小时×2 周)。盲法评估者在干预结束后立即以及 12 周后测量失语症严重程度(西方失语症成套测验修订版失语症商数)、词语检索、连贯言语、多模态交流、功能性交流和生活质量。探讨了可行性和可接受性。
在 70 名符合条件的参与者中,有 77%的人同意参加试验;78%的随机参与者完成了干预,98%的评估访问得以进行。疲劳和困扰评分较低,没有相关的退出。与试验相关的不良事件( = 4)的严重程度较轻。词语检索和功能性交流均显示出统计学上显著的治疗效果,两种干预措施的效果相当。
低-中强度的 CIAT-Plus 和 M-MAT 是可行和可接受的。两种干预措施在低-中强度下均显示出初步疗效。这些结果支持在低-中强度下对这些干预措施进行有力度的试验研究。