From Controlled Experimental Trial to Everyday Communication: How effective is intensive aphasia therapy under routine clinical conditions?
- Conditions
- R47.0I60I61I62I63I64Dysphasia and aphasiaSubarachnoid haemorrhageIntracerebral haemorrhageOther nontraumatic intracranial haemorrhage
- Registration Number
- DRKS00003337
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Background: Treatment guidelines for aphasia recommend intensive speech and language therapy for chronic (=6 months) aphasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness are scarce. We aimed to examine whether 3 weeks of intensive speech and language therapy under routine clinical conditions improved verbal communication in daily-life situations in people with chronic aphasia after stroke. Methods: In this multicentre, parallel group, superiority, open-label, blinded-endpoint, randomised controlled trial, patients aged 70 years or younger with aphasia after stroke lasting for 6 months or more were recruited from 19 inpatient or outpatient rehabilitation centres in Germany. An external biostatistician used a computer-generated permuted block randomisation method, stratified by treatment centre, to randomly assign participants to either 3 weeks or more of intensive speech and language therapy (=10 h per week) or 3 weeks deferral of intensive speech and language therapy. The primary endpoint was between-group difference in the change in verbal communication effectiveness in everyday life scenarios (Amsterdam-Nijmegen Everyday Language Test A-scale) from baseline to immediately after 3 weeks of treatment or treatment deferral. All analyses were done using the modified intention-to-treat population (those who received 1 day or more of intensive treatment or treatment deferral). This study is registered with ClinicalTrials.gov, number NCT01540383. Findings: We randomly assigned 158 patients between April 1, 2012, and May 31, 2014. The modified intention-to-treat population comprised 156 patients (78 per group). Verbal communication was significantly improved from baseline to after intensive speech and language treatment (mean difference 2·61 points [SD 4·94]; 95% CI 1·49 to 3·72), but not from baseline to after treatment deferral (-0·03 points [4·04]; -0·94 to 0·88; between-group difference Cohen's d 0·58; p=0·0004). Eight patients had adverse events during therapy or treatment deferral (one car accident [in the control group], two common cold [one patient per group], three gastrointestinal or cardiac symptoms [all intervention group], two recurrent stroke [one in intervention group before initiation of treatment, and one before group assignment had occurred]); all were unrelated to study participation. Interpretation: Three weeks of intensive speech and language therapy significantly enhanced verbal communication in people aged 70 years or younger with chronic aphasia after stroke, providing an effective evidence-based treatment approach in this population. Future studies should examine the minimum treatment intensity required for meaningful treatment effects, and determine whether treatment effects cumulate over repeated intervention periods.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 156
Presence of aphasia for at least 6 months after non-hemorrhagic or hemorrhagic cortical or subcortico-cortical stroke, native language German, participant's language abilities have to allow the administration of the Aachen Aphasia Test. Minimum level of required language ability defined as a) < 10 errors on the first section of the Token Test subtest of the Aachen Aphasia Test (AAT), b) a score of at least 1 in the AAT subtest 'Spontaneuous Speech' (level 1, communication ability).
1. Aphasia due to non-vascular etiology; 2. No evidence for aphasia (based on AAT subtests 'Token Test' and 'Written Language'; 3. severe untreated medical conditions which prohibit participation in intensive language therapy; 4. severe vision or hearing problems (uncorrected); 5. participation in another interventional or in intensive language therapy within four weeks before anticipated enrollment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapy-induced mean gain in Amsterdam Nijmegen Everyday Language Test ANELT understandability scores (ANELT A-scale; using the parallel versions ANELT-I and ANELT-II).<br>Performance at baseline is compared to performance immediately and 6 months post 3 weeks of 3 weeks of intensive language therapy. In patients with therapy allowance of > 3 weeks therapy will be continued, and in cases of a total therapy duration of <=5 weeks performance will be re-assessed after therapy completion. <br> <br>
- Secondary Outcome Measures
Name Time Method