Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Please note that as of 03/11/10 this trial has been completed.
Recruitment ended in February 2010. Final outcomes were collected in July 2010 and this data is currently being analysed.
Results will
the maximum duration is 16 weeks. The intervention period will be followed by an 8-week 'break'/ retention period.
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/01/2009: Adults diagnosed with aphasia and/or dysarthria following admission to hospital with a stroke. Previous inclusion criteria: Adults diagnosed with aphasia or dysarthria following admission to hospital with a stroke.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/01/2009: 1. Subarachnoid haemorrhage 2. Progressive dementia/ learning difficulties 3. Not able to receive therapy in the English language 4. Expected recovery without therapy Previous exclusion criteria: Subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 28/01/2009: The following will be assessed 6 months after randomisation: 1. Functional communicative ability. Blinded expert therapists will rate semi-structured conversation using the Therapy Outcomes Measures (TOMS) scale. 2. Economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. Carers will self-complete the ACT NoW 'Support for Others Questionnaire' and research assistants will gather data for participant health economics evaluation through hospital records. 3. Qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment. These will be assessed using qualitative interview schedules including rating scales developed specifically for this trial. Previous primary outcome measures: The primary outcome will be functional communicative ability. The economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. The qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 28/01/2009: The following will be assessed 6 months after randomisation: 1. Quality of life, assessed by Euroqol EQ-5D 2. Patients and carers self-reported ratings of functional communicative ability as measured by the Communication Outcome After Stroke (COAST) scale | — |
Countries
United Kingdom
Outcome results
None listed