■高强度约束诱发的失语症治疗加(CIAT-加)和多模态失语症治疗(M-MAT)是慢性卒中后失语症的有效干预措施,但在临床实践中具有挑战性。提供这些干预措施可能在较低强度下更可行,但是缺乏比较证据。因此,我们探讨了可行性,可接受性,以及在较低强度下治疗的初步疗效。
■多站点,单盲,随机II期试验在COMPAREIII期试验中进行.来自COMPARE试验常规护理组的慢性失语症参与者被随机分配到M-MAT或CIAT-Plus,以与COMPARE试验相同的剂量,但强度较低(6小时/周×5周,而不是15小时/周×2周)。盲人评估人员测量失语症严重程度(西方失语症电池修订失语症商),单词检索,连接语音,多模式通信,功能沟通,和生活质量立即干预后和12周后。探讨了可行性和可接受性。
■在70名符合条件的参与者中,77%同意该试验;78%的随机参与者完成了干预,98%的评估访问进行了。疲劳和困扰等级较低,没有相关的撤回。与试验相关的不良事件(n=4)严重程度较轻。在单词检索和功能交流方面证明了统计学上显着的治疗效果,两种干预措施都同样有效。
■低中重度CIAT-Plus和M-MAT是可行和可接受的。两种干预措施均在低-中等强度下显示出初步疗效。这些结果支持了在低-中等强度下研究这些干预措施的有力试验。
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 (n = 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.