Baumgaertner Annette, Grewe Tanja, Ziegler Wolfram, Floel Agnes, Springer Luise, Martus Peter, Breitenstein Caterina
Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Alte Rabenstraße 2, 20148 Hamburg, Germany.
Trials. 2013 Sep 23;14:308. doi: 10.1186/1745-6215-14-308.
Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia.
METHODS/DESIGN: Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative.The primary analysis tests for differences between the therapy group and an untreated (waiting list) control group with respect to pre- versus post 3-week-therapy (or waiting period, respectively) scores on the ANELT A-scale. Statistical between-group comparisons of primary and secondary outcome measures will be conducted in intention-to-treat analyses.Long-term stability of treatment effects will be assessed six months post intensive SLT (primary and secondary endpoints).
Registered in ClinicalTrials.gov with the Identifier NCT01540383.
治疗指南推荐言语和语言治疗（SLT）作为失语症治疗的“金标准”。治疗强度（即每周至少5小时的SLT）是SLT治疗效果的关键预测因素。鉴于缺乏随机对照试验（RCT），尤其是关于慢性失语症（首次中风后持续超过6个月）的试验，目前支持SLT疗效的科学证据并不令人满意。这项随机等待列表对照的多中心试验旨在研究在常规门诊和住院临床环境中提供的强化综合语言治疗是否能有效改善慢性中风后失语症患者的日常交流能力。
方法/设计：参与者为年龄在18至70岁之间的男性和女性，在缺血性或出血性中风后至少6个月，导致持续的语言障碍（即慢性失语症）；将筛选220名患者参与研究，目标是在26个月的招募期内至少纳入126名患者。基本的语言表达和理解能力需要保留（通过亚琛失语症测试评估）。治疗包括语言系统和交际语用练习，每天至少2小时，每周至少10小时，外加每天至少1小时的自我训练，持续至少三周。治疗内容根据患者的个体损伤情况进行调整。在治疗/等待期之前和之后，通过主要和次要结局指标评估患者的个体语言能力。主要（盲法）结局指标是阿姆斯特丹 - 奈梅亨日常语言测试（ANELT）的A量表（信息内容，即信息的“可理解性”），这是一种功能性沟通能力的标准化测量方法。次要（非盲法）结局指标是语言系统和交际语用语言筛查以及评估患者及其亲属所认为的生活质量的问卷。主要分析测试治疗组和未治疗（等待列表）对照组在治疗前与治疗3周后（或分别为等待期后）ANELT A量表得分之间的差异。将在意向性分析中对主要和次要结局指标进行组间统计学比较。将在强化SLT治疗后6个月评估治疗效果的长期稳定性（主要和次要终点）。
在ClinicalTrials.gov上注册，标识符为NCT01540383。
