Rotterdam Aphasia Therapy Study-3: The efficacy of early, intensive cognitive-linguistic therapy in aphasia after stroke (a randomized controlled trial).

Aphasia is present in about a quarter of all stroke patients and has a large impact on their communicative abilities in daily life. Some consider cognitive-linguistic therapy (CLT) as a “practice standard”. Others state that there is a need for well-designed trials in this field. CLT aims at improving processing on one or more of the affected linguistic components, e.g. semantics (word meaning) or phonology (word sound), resulting in a better verbal communication.
The Rotterdam Aphasia Therapy Study-3, a randomized controlled trial, evaluates the effect of intensive semantic and phonological treatment on verbal communication in an early stage of stroke.



Design:

Aphasic patients (n=150) will be randomized into 2 groups: (A) intensive (7 hours per week) CLT for 4 weeks, starting at the latest 2 weeks after stroke; and (B) deferred regular language therapy, starting 5-6 week after stroke. In the 5-6 weeks after stroke, no language therapy is allowed.
Our hypothesis is that early intensive short CLT is more effective than deferred therapy.

Early intensive short Cognitive Linguistic Therapy (CLT) with a speech and language therapist is more effective than deferred therapy.

1. Baseline: In week 1 and/or 2 (between 0 and 14 days) after stroke;

2. Post therapy: Following 4 weeks of intervention (4½ à 6 weeks after stroke);

3. Posttest: 3 months after inclusion;

4. Posttest: 6 months after inclusion.

Experimental group:

Intensive cognitive-linguistic language therapy; semantic and/or phonologic:

1. Semantic therapy with the cognitive-linguistic program BOX (E.G. Visch-Brink, I.M. Bajema, 2001) including a digital version: eBOX;

2. Phonological therapy with the cognitive-linguistic program FIKS (M. van Rijn, L. Booy, E.G. Visch-Brink, 2000), including a digital version: eFIKS.



Intensity: 7 hours a week (1 hour a day), of which at least 2 hours of therapy with a speech and language therapist.

Duration: 4 weeks.

Timing: As soon as possible after randomization, at the latest 2 weeks post onset.



Control group:

Deferred therapy.

Speech and language therapy will be deferred for four weeks. During those four weeks the controls receive no speech and language therapy.
Regular speech and language therapy starts four weeks after randomization; thus maximum at six weeks after the stroke.



All patients who meet the additional criteria will be asked to participate in a neuroimaging study subpart of RATS-3, FIAT, (Functional Imaging in Aphasia Therapy). These patients are randomized according to the RATS-3 protocol, but undergo MRI-scans pre-therapy, post-therapy and three months after the first MRI-scan to evaluate the neurophysiological correlate of the possible effect of CLT on verbal communication.

For FIAT an additional control group of chronic aphasic patients (n=40) and healthy participants (n=10) is added. Healthy participants will be scanned twice, with four weeks between sessions. Same RATS-3 randomization and intervention methods are applied to the group of chronic patients.