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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

1/07/2021

Date data sharing statement initially provided

17/01/2019

Date results 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]

Nil

Universal Trial Number (UTN)

U1111-1123-0259

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

Condition category

Condition code

Stroke

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]

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]

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]

First week post-stroke, 3 and 6 months post-stroke

Primary outcome [2]

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]

First week post-stroke, 3 and 6 months post-stroke

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

15/01/2011

Actual

25/07/2011

Date of last participant enrolment

Anticipated

31/12/2019

Actual

17/09/2019

Date of last data collection

Anticipated

20/03/2020

Actual

20/03/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Individual

Name [1]

Kathy Clark

Address [1]

Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Kathryn Hayward

Address [1]

School of Health and Rehabilitation Sciences
Building 84A (Therapies building)
The University of Queensland
St Lucia QLD 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Services District Human Research Ethics Committee

Ethics committee address [1]

Centres for Health Research
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/01/2011

Ethics approval number [1]

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

Dr Emma Finch

Address

Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3896 3133

Fax

[email protected]

Contact person for public queries

Name

Emma Finch

Address

Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3896 3133

Fax

[email protected]

Contact person for scientific queries

Name

Emma Finch

Address

Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3896 3133

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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