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Trial registered on ANZCTR


Registration number
ACTRN12611000767909
Ethics application status
Approved
Date submitted
20/07/2011
Date registered
21/07/2011
Date last updated
28/01/2020
Date data sharing statement initially provided
17/01/2019
Date results information initially provided
28/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of thrombolysis on communication and swallowing outcomes following stroke
Scientific title
The effects of thrombolysis on communication and swallowing recovery in patients with an ischaemic stroke compared with non-thrombolysed patients
Secondary ID [1] 262661 0
Nil
Universal Trial Number (UTN)
U1111-1123-0259
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 268367 0
Condition category
Condition code
Stroke 268501 268501 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will investigate the effects of thrombolysis using recombinant tissue plasminogen activators (rt-PA) on communication and swallowing recovery after ischaemic stroke. During the study we will record patient communication and swallowing outcomes through observational measures at different time points along the recovery continuum (the first week post-stroke, and then 3 and 6 months later). We will compare the recovery patterns between patients who are lysed and patients who are not lysed. No thrombolytic drugs will be administered during the study (ie. Participants will be lysed on admission to hospital by the hsopital medical team as per the hospital thrombolysis guidelines prior to entry into the study).
Intervention code [1] 267022 0
Not applicable
Comparator / control treatment
The control group will consist of patients who were not thrombolysed on admission to hospital. During the study we will record patient communication and swallowing outcomes through observational measures at different time points along the recovery continuum (the first week post-stroke, and then 3 and 6 months later).
Control group
Active

Outcomes
Primary outcome [1] 269244 0
Change in communication and cognitive function as measured by standardised assessments (Western Aphasia Battery, Measure of Cognitive-Linguistic Abilities, and CogniSTAT) for participants according to study group (thrombolysis vs. control) and according to stroke site (left vs. right stroke)
Timepoint [1] 269244 0
First week post-stroke, 3 and 6 months post-stroke
Primary outcome [2] 269266 0
Change in swallowing function as measured by the RBHOMS for participants according to study group (thrombolysis vs. control) and according to stroke site (left vs. right stroke)
Timepoint [2] 269266 0
First week post-stroke, 3 and 6 months post-stroke
Secondary outcome [1] 279246 0
Change in general physical function as measured by observational measures (Functional Independence Measure, Motor Assessment Scale) for participants according to study group (thrombolysis vs. control) and according to stroke site (left vs. right stroke)
Timepoint [1] 279246 0
First week post-stroke, 3 and 6 months post-stroke

Eligibility
Key inclusion criteria
Participants will have been admitted to hospital following an ischaemic stroke. Participants will have English as their primary language and will not have previously received thrombolysis.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any individuals with other neurological conditions, a hisotry of previous stroke or head injury, or a NIHSS score of greater than 22 will be excluded

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2297 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 267485 0
Self funded/Unfunded
Name [1] 267485 0
Address [1] 267485 0
Country [1] 267485 0
Primary sponsor type
Individual
Name
Emma Finch
Address
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 266526 0
Individual
Name [1] 266526 0
Kathy Clark
Address [1] 266526 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 266526 0
Australia
Other collaborator category [1] 277916 0
Individual
Name [1] 277916 0
Dr Kathryn Hayward
Address [1] 277916 0
School of Health and Rehabilitation Sciences
Building 84A (Therapies building)
The University of Queensland
St Lucia QLD 4072
Country [1] 277916 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269451 0
Metro South Health Services District Human Research Ethics Committee
Ethics committee address [1] 269451 0
Centres for Health Research
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [1] 269451 0
Australia
Date submitted for ethics approval [1] 269451 0
Approval date [1] 269451 0
13/01/2011
Ethics approval number [1] 269451 0
HREC/10/QPAH/293

Summary
Brief summary
Stroke is currently the second highest cause of death in Australia and a leading source of disability (National Stroke Foundation, 2010). Some strokes are caused by a blockage in a blood vessel within the brain. Evidence suggests that thrombolysis (i.e., administering a drug to dissolve the blockage) shortly after a stroke may reduce some of the neurological damage (Wardlaw, Murray, Berge, & del Zoppo, 2009; Williams et al., 2009). One such drug is called recombinant tissue plasminogen activator (rt-PA). Very little is known about the effects of rt-PA on the recovery of communication or swallowing function. This has significant implications for patient rehabilitation, as it is unknown whether patients who receive rt-PA will respond differently to traditional behavioural rehabilitation methods post-stroke or improve at different rates. It is also unknown whether the effects of rt-PA on post-stroke recovery differ according to stroke location. As a result, the proposed study will investigate the effects of thrombolysis on the recovery of communication and swallowing function after stroke. Increasing our knowledge in this area will assist in the development of effective patient rehabilitation programs to maximise quality of life post-stroke.

Aims
The overall aim of the project is to investigate the effects of thrombolysis on the recovery of communication and swallowing function after ischaemic stroke. Specifically, the project will investigate whether patients who receive rt-PA following an ischaemic stroke differ from patients who do not receive the drug with respect to language, speech and swallowing function. The project will also investigate whether these communication and swallowing recovery patterns differ following rt-PA over the first 6 months post-stroke. Finally, given the difference in communication disorders resulting from stroke location, the study will investigate whether there is a difference in the effects of rt-PA on communication and swallowing outcomes according to whether patients experienced a left or right sided stroke.
Trial website
Nil
Trial related presentations / publications
Finch, E., Fleming, J., Clark, K., & Hayward, K. (in press). Interdisciplinary rehabilitation outcomes following thrombolysis for acute ischaemic stroke: A case series. Neurorehabilitation: An interdisciplinary journal

Finch, E., Hayward, K., Fleming, J., & Copland, D. (2013). Identifying implications of thrombolysis for stroke rehabilitation: Knowledge gaps in current research. Disability and Rehabilitation.
Public notes

Contacts
Principal investigator
Name 32895 0
Dr Emma Finch
Address 32895 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 32895 0
Australia
Phone 32895 0
+61 7 3896 3133
Fax 32895 0
Email 32895 0
e.whiting@uq.edu.au
Contact person for public queries
Name 16142 0
Dr Emma Finch
Address 16142 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 16142 0
Australia
Phone 16142 0
+61 7 3896 3133
Fax 16142 0
Email 16142 0
e.whiting@uq.edu.au
Contact person for scientific queries
Name 7070 0
Dr Emma Finch
Address 7070 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 7070 0
Australia
Phone 7070 0
+61 7 3896 3133
Fax 7070 0
Email 7070 0
e.whiting@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As the data are health data about individuals no individual patient data will be shared
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6624 0
Finch, E., Fleming, J., Clark, K., & Hayward, K. S. (2014). Interdisciplinary rehabilitation outcomes following thrombolysis for acute ischaemic stroke: A case series. NeuroRehabilitation, 35(1), 9-16.
Attachments [1] 6624 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary