Open Access Study protocol

Rotterdam Aphasia Therapy Study (RATS) – 3: “The efficacy of intensive cognitive-linguistic therapy in the acute stage of aphasia”; design of a randomised controlled trial

Femke Nouwens1*, Diederik WJ Dippel1, Marjolein de Jong-Hagelstein1, Evy G Visch-Brink1, Peter J Koudstaal1, Lonneke M L de Lau12 and RATS-3 investigators

Author Affiliations

1 Department of Neurology, Erasmus MC – University Medical Center Rotterdam, P.O. Box 2040, Rotterdam, CA, 3000, The Netherlands

2 Department of Neurology, Slotervaart Hospital, Amsterdam, The Netherlands

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Trials 2013, 14:24  doi:10.1186/1745-6215-14-24

Published: 23 January 2013

Abstract

Background

Aphasia is a severely disabling condition occurring in 20 to 25% of stroke patients. Most patients with aphasia due to stroke receive speech and language therapy. Methodologically sound randomised controlled trials investigating the effect of specific interventions for patients with aphasia following stroke are scarce. The currently available evidence suggests that intensive speech and language therapy is beneficial for restoration of communication, but the optimal timing of treatment is as yet unclear.

In the Rotterdam Aphasia Therapy Study-3 we aim to test the hypothesis that patients with aphasia due to stroke benefit more from early intensive cognitive-linguistic therapy than from deferred regular language therapy.

Methods/design

In a single blinded, multicentre, randomised controlled trial, 150 patients with first ever aphasia due to stroke will be randomised within two weeks after stroke to either early intensive cognitive-linguistic therapy (Group A) or deferred regular therapy (Group B). Group A will start as soon as possible, at the latest two weeks after stroke, with a four week period of one hour a day treatment with cognitive-linguistic therapy. In Group B professional speech and language therapy is deferred for four weeks. After this period, patients will follow the conventional procedure of speech and language therapy. Participants will be tested with an extensive linguistic test battery at four weeks, three months and six months after inclusion. Primary outcome measure is the difference in score between the two treatment groups on the Amsterdam-Nijmegen Everyday Language Test, a measure of everyday verbal communication, four weeks after randomisation.

Trial registration

This trial is registered in the Dutch Trial Register (http://www.trialregister.nl webcite), NTR3271.

Keywords:
Aphasia; Stroke; Cognitive-linguistic therapy; Treatment; Timing; Intensity; RCT