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      Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial

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          Abstract

          Background

          Aphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke.

          Methods/Design

          A total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls.

          Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio will be calculated. Treatment fidelity will be monitored.

          Discussion

          This is the first fully powered trial of the clinical and cost effectiveness of computerised aphasia therapy. Specific challenges in designing the protocol are considered.

          Trial registration

          Registered with Current Controlled Trials ISRCTN68798818 on 18 February 2014.

          Related collections

          Most cited references 29

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          Speech and language therapy for aphasia following stroke.

          Aphasia is an acquired language impairment following brain damage that affects some or all language modalities: expression and understanding of speech, reading and writing. Approximately one-third of people who have a stroke experience aphasia. To assess the effectiveness of speech and language therapy (SLT) for aphasia following stroke. We searched the Cochrane Stroke Group Trials Register (last searched June 2011), MEDLINE (1966 to July 2011) and CINAHL (1982 to July 2011). In an effort to identify further published, unpublished and ongoing trials we handsearched the International Journal of Language and Communication Disorders (1969 to 2005) and reference lists of relevant articles and contacted academic institutions and other researchers. There were no language restrictions. Randomised controlled trials (RCTs) comparing SLT (a formal intervention that aims to improve language and communication abilities, activity and participation) with (1) no SLT; (2) social support or stimulation (an intervention that provides social support and communication stimulation but does not include targeted therapeutic interventions); and (3) another SLT intervention (which differed in duration, intensity, frequency, intervention methodology or theoretical approach). We independently extracted the data and assessed the quality of included trials. We sought missing data from investigators. We included 39 RCTs (51 randomised comparisons) involving 2518 participants in this review. Nineteen randomised comparisons (1414 participants) compared SLT with no SLT where SLT resulted in significant benefits to patients' functional communication (standardised mean difference (SMD) 0.30, 95% CI 0.08 to 0.52, P = 0.008), receptive and expressive language. Seven randomised comparisons (432 participants) compared SLT with social support and stimulation but found no evidence of a difference in functional communication. Twenty-five randomised comparisons (910 participants) compared two approaches to SLT. There was no indication of a difference in functional communication. Generally, the trials randomised small numbers of participants across a range of characteristics (age, time since stroke and severity profiles), interventions and outcomes. Suitable statistical data were unavailable for several measures. Our review provides some evidence of the effectiveness of SLT for people with aphasia following stroke in terms of improved functional communication, receptive and expressive language. However, some trials were poorly reported. The potential benefits of intensive SLT over conventional SLT were confounded by a significantly higher dropout from intensive SLT. More participants also withdrew from social support than SLT interventions. There was insufficient evidence to draw any conclusion regarding the effectiveness of any one specific SLT approach over another.
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            Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy.

            In response to the established notion that improvement of language functions in chronic aphasia only can be achieved through long-term treatment, we examined the efficacy of a short-term, intensive language training, constraint-induced aphasia therapy (CIAT). This program is founded on the learning principles of prevention of compensatory communication (constraint), massed practice, and shaping (induced). Twenty-seven patients with chronic aphasia received 30 hours of training over 10 days. Twelve patients were trained with the CIAT program. For 15 patients the training included a module of written language and an additional training in everyday communication, which involved the assistance of family members (CIATplus). Outcome measures included standardized neurolinguistic testing and ratings of the quality and the amount of daily communication. Language functions improved significantly after training for both groups and remained stable over a 6-month follow-up period. Single case analyses revealed statistically significant improvements in 85% of the patients. Patients and relatives of both groups rated the quality and amount of communication as improved after therapy. This increase was more pronounced for patients of the group CIATplus in the follow-up. Results confirm that a short-term intense language training, based on learning principles, can lead to substantial and lasting improvements in language functions in chronic aphasia. The use of family and friends in the training provides an additional valuable element. This effective intervention can be successfully used in the rehabilitation of chronic aphasia patients. Additionally, its short-term design makes it economically attractive for service providers.
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              Evidence-based systematic review: effects of intensity of treatment and constraint-induced language therapy for individuals with stroke-induced aphasia.

              This systematic review summarizes evidence for intensity of treatment and constraint-induced language therapy (CILT) on measures of language impairment and communication activity/participation in individuals with stroke-induced aphasia. A systematic search of the aphasia literature using 15 electronic databases (e.g., PubMed, CINAHL) identified 10 studies meeting inclusion/exclusion criteria. A review panel evaluated studies for methodological quality. Studies were characterized by research stage (i.e., discovery, efficacy, effectiveness, cost-benefit/public policy research), and effect sizes (ESs) were calculated wherever possible. In chronic aphasia, studies provided modest evidence for more intensive treatment and the positive effects of CILT. In acute aphasia, 1 study evaluated high-intensity treatment positively; no studies examined CILT. Four studies reported discovery research, with quality scores ranging from 3 to 6 of 8 possible markers. Five treatment efficacy studies had quality scores ranging from 5 to 7 of 9 possible markers. One study of treatment effectiveness received a score of 4 of 8 possible markers. Although modest evidence exists for more intensive treatment and CILT for individuals with stroke-induced aphasia, the results of this review should be considered preliminary and, when making treatment decisions, should be used in conjunction with clinical expertise and the client's individual values.
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                Author and article information

                Contributors
                r.l.palmer@sheffield.ac.uk
                c.l.cooper@sheffield.ac.uk
                p.m.enderby@sheffield.ac.uk
                M.Brady@gcu.ac.uk
                s.a.julious@sheffield.ac.uk
                audrey.bowen@manchester.ac.uk
                n.latimer@shef.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                27 January 2015
                27 January 2015
                2015
                : 16
                Affiliations
                [ ]School of Health and Related Research, University of Sheffield, 107 Innovation Centre, 217 Portobello, Sheffield, S1 4DP England
                [ ]Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G40BA England
                [ ]Medical Statistics Group, School of Health and Related Research, University of Sheffield, Regent Court, Regent Street, Sheffield, S1 4DA England
                [ ]Reader, School of Psychological Sciences, University of Manchester (MAHSC), Joint theme lead - Patient-Centred Care, NIHR CLAHRC Greater Manchester, Centre for Stroke and Vascular Research, CSB, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD England
                [ ]Senior Research Fellow in Health Economics, Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA England
                Article
                527
                10.1186/s13063-014-0527-7
                4318176
                25623162
                © Palmer et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Study Protocol
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                © The Author(s) 2015

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