None listed
Conditions
Brief summary
Trial Objectives To demonstrate that a standardised and prescribed intensive speech therapy regimen for aphasia is more effective and cost saving than non-standardised usual care training methods in the very early post-stroke recovery period. Primary Hypothesis: Very early aphasia therapy will result in greater improvement in communication at 12 weeks post-stroke, as measured by the Western Aphasia Battery-Revised; Aphasia Quotient (WAB-R (AQ)). Secondary Hypotheses: 1. VERSE aphasia therapy will result in a greater improvement in communication than UC-Plus aphasia therapy at 12 and 26 weeks post stroke, as measured by the WAB-R (AQ). 2. VERSE aphasia therapy and UC-Plus will each result in greater improvements in communication than U C alone, as measured by the WAB-R(AQ), at 12 weeks and 26 weeks post stroke. 3. VERSE aphasia therapy will result in greater improvements in connected speech than UC-Plus, as measured by Discourse Analysis, at 12 weeks and 26 weeks post stroke. 4. VERSE aphasia therapy and UC-Plus will each result in greater improvements in connected speech than UC alone, as measured by Discourse Analysis, at 12 weeks and 26 weeks post stroke. 5. Very early aphasia therapy (UC-Plus and VERSE) will result in better quality of life at 12 and 26 weeks post stroke than UC control. 6. Very early aphasia therapy (UC-Plus and VERSE) will be more cost-effective than UC at 12 and 26 weeks post stroke.
Interventions
Arm Two Usual care Plus - Increased intensity of speech therapy sessions (uncontrolled) The therapy provided is at the discretion of the speech therapist based on usual care speech therapy provided in the stroke unit. It involves a combination of non standardised aphasia therapy, counselling and patient/family education however the intensity or the number of treamtent sessions will be specified and equivalent to 20 sessions of 45 - 60 minutes. There will be a minimum of 3 and a maximum of 5 sessions per week. Intevention must be completed within a maximum 25 working days after baseline assessment. Arm 3 VERSE intervention - Increased intensity of speech therapy sessions (prescribed) The number of sessions will be equal to arm 2 (20 sessions of 45 - 60 minutes of 1:1 speech therapy, but the intervention will be standardised and prescribed by an expert advisory committee for the therapist to follow. The intervention will be specifically tailored to meet specific set goals based on patients needs and include predominantly direct 1:1 therapy. All sessions in all arms of treatment will be recorded. Documentation will include the date, duration and content of each session. A random sample of sessions will be recorded and submitted to the study monitor to ensure adherence to the protocol.
Sponsors
Study design
Eligibility
Inclusion criteria
Acute stroke with resultant acute aphasia of any type and score < 93.7 of the Aphasia Quotient (no TIA, SAH or SDH) Medical stability at recruitment Ability to maintain a wakeful alert state for 30 consecutive minutes within 14 days of stroke onset Normal or corrected hearing and vision.
Exclusion criteria
Pre-existing clinical diagnosis of dementia Diagnosis or treatment of major depression at the time of enrolment Concurrent participation in another interventional trial