From Controlled Experimental Trial to Everyday Communication: How Effective is Intensive Aphasia Therapy Under Routine Clinical Conditions?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 156
- Locations
- 2
- Primary Endpoint
- Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale
Study Overview
Brief Summary
The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in improving everyday communication in postacute/chronic post-stroke aphasia, as measured by performance on the Amsterdam Nijmegen Everyday Language Test (ANELT).
Detailed Description
Aims of the study:
This multicenter randomized placebo-controlled study aims to examine whether integrative intensive (> 10 hours/week for at least 3 weeks) language and communication therapy administered under routine clinical conditions translates into a statistically significant functional improvement of everyday communication in patients with chronic aphasia (i.e., aphasia persisting for 6 or more months after the stroke). A further aim is to examine whether therapy-induced improvements are still maintained over a period of six months. The study's results may lead to more targeted treatment regimens and thus to an enhancement of health-related quality of life in persons with chronic aphasia. The data will further provide evidence-based guidelines of best practice in the rehabilitation of persons with chronic aphasia.
Methods:
Fourteen in- and outpatient rehabilitation centres across Germany participate in the study. Via a digital randomization procedure, patients are allocated to one of two groups: an experimental group, starting as soon as feasible with treatment lasting 3 to 6 weeks, and a waiting list control group, whose therapy begins after a three-week delay. Both groups receive a combination of language systematic and communicative-pragmatic language therapy. Everyday language ability will be examined with a standardized outcome measure, and compared between groups at several points: immediately before as well as immediately after and 6 months after completion of (3-6 weeks) intensive language therapy.
Statistical analyses:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •presence of aphasia for at least 6 months after non-hemorrhagic or hemorrhagic cortical or subcortical-cortical stroke
- •native language German
- •participant's comprehension ability needs to be sufficiently high to give informed consent
- •participant's language abilities have to allow the administration of the Aachen Aphasia Test (AAT)
Exclusion Criteria
- •aphasia due to non-vascular etiology
- •no evidence for aphasia (based on AAT subtests 'Token Test' and 'Written Language'
- •severe untreated medical conditions which prohibit participation in intensive language therapy
- •severe vision or hearing problems (uncorrected)
- •participation in another interventional or language therapy study within four weeks before potential enrollment
Arms & Interventions
Intensive aphasia therapy group
Group starts intensive integrative aphasia therapy within 3 workdays (or as soon as possible) after baseline exam
Intervention: Intensive integrative aphasia therapy (Behavioral)
Waiting list control group
Group starts intensive integrative aphasia therapy after a waiting period of at least three weeks
Intervention: Waiting list control group (Behavioral)
Outcomes
Primary Outcomes
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale
Time Frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
Mean gain in ANELT understandability scores (ANELT A-scale; using the parallel versions ANELT-I and ANELT-II)
Secondary Outcomes
- morbidity measure: changes in communicative-pragmatic screening (KOPS)(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- morbidity measure: changes in Modified Rankin Scale(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- quality of life measure: changes in German version of the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- morbidity measure: changes in language-systematic aphasia screening (SAPS)(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- quality of life measure: changes in Communicative Effectiveness Index (CETI) and the ANELT partner communication questionnaire(Baseline is compared to performance 6 months post 3 weeks of intensive language therapy.)
- morbidity measure: changes in nonverbal cognitive functions(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- quality of life measure: changes in Visual analog mood scales (VAMS)(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - B-scale(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - syntactic rating(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))
- changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - nonverbal communication rating(Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks))