Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions "FCET2EC"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Intensive integrative aphasia therapy Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Intensive aphasia therapy group
    Description: Group starts intensive language therapy within 3 workdays (or as soon as possible) after baseline exam
  • Waiting list control group Behavioral
    Intervention Desc: Control group starts intensive language therapy after a 3-week waiting period.
    ARM 1: Kind: Experimental
    Label: Waiting list control group

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary quality of life measure: changes in Communicative Effectiveness Index/CETI and the ANELT partner communication questionnaire 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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. No

Sponsors