Abstract
BackgroundTherapy 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/DesignParticipants 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).Trial registrationRegistered in ClinicalTrials.gov with the Identifier NCT01540383
Highlights
Therapy guidelines recommend speech and language therapy (SLT) as the “gold standard” for aphasia treatment
Apart from the emotional burden associated with aphasia [8], language dysfunction in the postacute or chronic phase after a stroke is a major reason for failure of vocational rehabilitation [9]
The scientific evidence to support the efficacy of SLT is unsatisfactory to date [12] given the lack of randomized controlled trials (RCTs), with respect to chronic aphasia
Summary
Aging populations and higher survival rates in patients with acute stroke place increasing financial constraints on the health care system, requiring evidence-based interventions in stroke rehabilitation [1,2,3]. Even though recent evidence-based reviews support the efficacy of intensive aphasia therapy [2,13], the available evidence has not yet led to increased referrals for aphasia patients This state of affairs may in part be due to a lack of high-quality RCTs with positive outcome as well as to a failure to administer a functional outcome measure. Apart from questionnaires asking patients and relatives to indicate the estimated level of communicative abilities, primary outcome measures in these studies were operationalized as changes in scores of standardized language test batteries. In the past two years, several RCTs with large numbers of participants have used primary outcome measures focused on functional communication ability [23,24,25] In all of these trials, treatment started within the period of spontaneous remission after the initial stroke. For patients with stroke-induced chronic aphasia, an evaluation of the efficacy of intensive integrative, systematic therapy with respect to everyday communication ability is urgently needed
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