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Very Early Rehabilitation in Speech in patients with aphasia following stroke.

A three armed, prospective multicentre randomised controlled speech therapy trial comparing usual care, usual care plus and Very Early Rehabilitation in Speech (VERSE) with blinded outcome assessment of the Aphasia Quotient score in patients with aphasia following acute stroke.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000776707
Acronym
VERSE
Enrollment
246
Registered
2013-07-11
Start date
2014-06-05
Completion date
2018-02-12
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 s

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

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026