Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions
Condition: Aphasia; Stroke
MeSH terms: Aphasia
Study type: Interventional

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:

      The primary analysis compares the changes in functional communication ability (as indicated
      by changes of pre- to post-therapy functional communication scores on the primary outcome
      measure, the ANELT) between the experimental and the waiting list control group in an
      intention-to-treat (ITT) design. To balance for unequal treatment durations across patient
      ("naturalistic treatment setting"), the critical pre- to post therapy interval is fixed at
      three weeks, with the option of extension of therapy (provided it is granted by the sickness
      fund) and re-test after termination of therapy. The long-term stability of potential
      treatment gains will be re-evaluated 6 months post therapy.

      Further exploratory analyses will examine therapy-induced changes in secondary outcome
      measures (see below) in the experimental compared to the waiting list control group.

      Considering that age, gender, time post stroke onset, aphasia type (fluent, non-fluent),
      aphasia severity (based on the Aachen Aphasia Test [AAT] profile score), the total hours of
      therapy provided, type of stroke (cortical strokes with or without subcortical involvement),
      the amount of therapy-concomitant self-administered language practice (e.g. computer-aided
      practice), and concurrent physio- and neuropsychological therapies might influence functional
      outcome, the above factors will be included in a multivariate analysis with variable
      selection. The amount of outpatient therapy provided after discharge from intensive treatment
      will be statistically controlled by covariate analyses.

      Finally, the investigators expect that therapy effects in the waiting list control group will
      be comparable to those of the experimental group. Thus, after initiation of therapy in the
      control group after a three-week delay, outcome data will be collected in analogy to the
      experimental group, and will serve to replicate potential effects of intensive language
      therapy under routine clinical conditions.
    

Intervention name(s): Intensive integrative aphasia therapy; Waiting list control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intensive language therapy (3 weeks, 5 days/week, >=2 hours/day) provided in regular clinical setting and consisting of a combination of language systematic and communicative-pragmatic treatment; Control group starts intensive language therapy after a 3-week waiting period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Communication; Language; Treatment; Intervention; Therapy; Efficacy; Maintenance; Recovery; Outcome; Rehabilitation; Treatment Intensity; Language Impairment; Intensive Language Therapy; Functional Communication; Functional Improvement; Evidence-Based Intervention; High-Frequency