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* Note that it is not mandatory for researchers to provide a study phase. Therefore, some relevant trials may not be included in the search results if you search by a specific study phase.

The safety and scientific validity of each study registered on the ANZCTR is the responsibility of the study sponsor and investigators. Listing a study on the ANZCTR does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to information for consumers

Number of records retrieved: 86



Page: 1 2 3 4 5 

Trial from ANZCTR

How feasible and effective is it for physiotherapists to deliver a high intensity treadmill training and self-management program to stroke patients undergoing rehabilitation?

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 5/11/2015)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12613000764730

Date registered

09 July 2013

Health condition

People with stroke

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 November 2013

Ethics application status

Approved

Brief summary

Stroke is a leading cause of disability amongst Australians. After stroke, activity levels are low, with few people able to exercise at an intensity which will reduce the risk of future cardiovascular events. This project examines the feasibility and effectiveness of usual physiotherapy staff in rehabilitation implementing a combined high intensity treadmill training program with a self management approach to improve activity levels, mobility, cardiovascular risk profile in stroke survivors, increasing their independence and reducing the burden of care. In addition, this project will investigate the barriers and facilitators to physiotherapists implementing this approach to stroke management as part of their clinical practice.

Eligibility

Key inclusion criteria

Within 2 months of stroke.
Aged over 18 years.
Able to walk independently for 10m with or without an aid. Able to understand 3-stage commands

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Unable to walk independently prior to current stroke
Co-morbidities that might limit walking (e.g., arthritis, Parkinson's disease, brain injury)
Unstable cardiac status
Unable to understand instructions
Unable to provide informed consent

Contact details and further information

Primary Sponsor

Type: University
Name: University of Queensland
Address: St Lucia
Brisbane, QLD
4072
Country: Australia

Contact person for information and recruitment

Prof Sandra Brauer
Therapies Building (84a)
University of Queensland
St Lucia Campus QLD
4072
Australia
+617 3365 2317
s.brauer@uq.edu.au



Trial from ANZCTR

In stroke patients undergoing rehabilitation, does high intensity treadmill training embedded in a self-management approach result in increased levels of physical activity at 8 and 26 weeks compared to usual physiotherapy care.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 7/6/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12613000744752

Date registered

04 July 2013

Health condition

People with stroke

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 November 2013

Ethics application status

Approved

Brief summary

Stroke is a leading cause of disability amongst Australians. After stroke, activity levels are low, with few people able to exercise at an intensity which will reduce the risk of future cardiovascular events. This project examines the effectiveness of implementing a combined high intensity treadmill training program embedded in a self-management approach to improve activity levels, mobility, cardiovascular risk profile in stroke survivors, increasing their independence and reducing the burden of care.

Eligibility

Key inclusion criteria

Within 2 months of stroke
Aged over 18 years
Able to walk independently for 10m with or without an aid
Able to understand 3-stage commands

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Unable to walk independently prior to current stroke
Have co-morbidities that might limit walking (e.g., arthritis, brain injury, Parkinson's Disease)
Unstable cardiac status
Unable to understand/follow instructions
Unable to return for assessment or training
Unable to give informed consent

Contact details and further information

Primary Sponsor

Type: University
Name: The University of Queensland
Address: Brisbane St Lucia, QLD 4072
Country: Australia

Contact person for information and recruitment

Prof Sandra Brauer
Therapies Building (84A)
The University of Queensland
St Lucia
QLD 4072 Australia
Australia
+61 7 3365 2317
s.brauer@uq.edu.au



Trial from ANZCTR

Feasibility of biofeedback training to improve gait function in people with stroke

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 12/3/2013)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12613000286741

Date registered

12 March 2013

Health condition

stroke

Recruitment countries

Australia

Recruitment site location(s) (State)

Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

08 March 2013

Ethics application status

Approved

Brief summary

The aim of this project is to demonstrate the feasibility of using visual feedback to increase minimum toe clearance during walking in people with stroke. This intervention has the potential to improve walking safety and reduce falls. Ten participants will be required to attend 10 sessions. The training sessions will occur over a 3-4 week period, with at least one rest day between sessions. At all sessions, participants will be required to walk on a treadmill for 5-10 minutes. They will wear exercise shorts and also a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. They will also wear insoles in their shoes (FScan), which will record pressure under their feet. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, participants will be asked to modify their walking pattern to match a “target” minimum toe clearance.

Eligibility

Key inclusion criteria

Participants will be adults over 18 years who have suffered a stroke at least 6 months previously. Participants must be able to walk independently 50 m (with or without a stick) and be able to give informed consent. They must not be receiving any physiotherapy during the 8 weeks of the study. They must also be able to understand and follow instructions in English.

Minimum age

18 Years

Maximum age

85 Years

Gender

Both males and females

Key exclusion criteria

Participants will be excluded if they require an ankle foot orthosis, as this may limit their ability to modify toe clearance. Participants will be excluded if they have any other neurological, orthopaedic, cardiac, respiratory or other medical conditions that may impact on their walking or their ability to walk on a treadmill. Participants who are pregnant will be excluded. Participants with visual problems or visual-spatial neglect will also be excluded. Stoke patients who may be “stabilising” will be excluded from the study.

Contact details and further information

Primary Sponsor

Type: Individual
Name: Dr Cathy Said
Address: Physiotherapy Site Manager,
Heidelberg Repatriation Hospital,
PO Box 5444, Heidelberg West
VIC 3084

Country: Australia

Contact person for information and recruitment

Dr Cathrine Said
Physiotherapy Department
Heidelberg Repatriation Hospital
PO Box 5444
Heidelberg West
VIC 3084
Australia
+61 3 9496 2055
cathy.said@austin.org.au



Trial from ANZCTR

Multicentre, prospective, randomised open-label blinded endpoint (PROBE) phase III study in stroke thrombolysis patients to compare tenecteplase and alteplase for an outcome of less disability at 3 months.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 17/8/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12613000243718

Date registered

28 February 2013

Health condition

Acute ischaemic stroke

Recruitment countries

Australia, Taiwan, Province Of China, Canada, United Kingdom, Spain, Belgium, New Zealand

Recruitment site location(s) (State)

Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 May 2013

Ethics application status

Approved

Brief summary

This research is comparing two clot dissolving medications tenecteplase and alteplase. Tenecteplase is not currently licensed and approved for use in acute stroke care, but has shown very promising results in recent stroke studies. Alteplase is the approved medication for ischaemic stroke. Despite the clear benefits of alteplase at reducing brain damage and disability, we would like to find a medication that has similar clot-dissolving effects with a lower risk of brain bleeding. This would result in an even greater reduction in long-term stroke disability.

The aim of this study is to compare alteplase with tenecteplase for stroke treatment to determine which will help more patients have less disability at 3 months following their stroke.

Eligibility

Key inclusion criteria

1. Patients presenting with acute hemispheric ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset.
2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.

Imaging inclusion criteria:
1. Presence of penumbra - Using CTP or perfusion MR mismatch between the Tmax > 6 seconds delay perfusion volume and CTP relative cerebral blood flow (relCBF) or diffusion MR lesion infarct core volume
a) Mismatch ratio between Tmax perfusion lesion volume and infarct core lesion volume of > 1.8
b) Penumbra volume > 15 mL (Tmax lesion volume –infarct core lesion volume), and
2. Infarct core lesion volume < 70 mL. Note minimum slice coverage required for CTP will be 80 mm to prevent underestimation of infarct core volume with this modality.
3. Volume of severely hypoperfused tissue < 100mL (Tmax > 10 seconds delay or Delay Time > 8 seconds) indicative of poor response to reperfusion.

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

1. Intracranial haemorrhage (ICH) identified by CT or MRI.
2. Rapidly improving symptoms at the discretion of the investigator.
3. Pre-stroke mRS score of greater than or equal to 2 (indicating previous disability).
4. Participation in any investigational study in the previous 30 days.
5. Any terminal illness such that patient would not be expected to survive more than 1 year.
6. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
7. Pregnant women.
8. Previous stroke within last three months.
9. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
10. Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (INR > 1.5).
11. Current use of novel oral anticoagulants (NOACs) (i.e. dabigatran, rivaroxaban, or apixiban).
12. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
13. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or or low-dose aspirin) prior to study entry is permitted.
14. Clinically significant hypoglycaemia.
15. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or > 110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of “aggressive treatment” is left to the discretion of the responsible Investigator.
16. Hereditary or acquired haemorrhagic diathesis.
17. Gastrointestinal or urinary bleeding within the preceding 21 days.
18. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
19. Exposure to a thrombolytic agent within the previous 72 hours.
20. An extracranial or intracranial internal carotid artery occlusion or a proximal M1 middle cerebral artery occlusion which, in the judgment of the investigator, would be more appropriately treated with combined intravenous intra-arterial therapy, where the intra-arterial therapy can be accessed and delivered within a rapid time frame.

Contact details and further information

Primary Sponsor

Type: Other Collaborative groups
Name: Acute Stroke Service
Address: Department of Neurology
John Hunter Hospital
Locked Bag 1
HRMC NSW 2310
Country: Australia

Contact person for information and recruitment

Ms Michelle Russell
Department of Neurology
John Hunter Hospital
Locked Bag 1
HRMC NSW 2310
Australia
+61 2 4921 3450
michelle.russell@hnehealth.nsw.gov.au



Trial from ANZCTR

In adults with non-progressive dysarthria resulting from stroke or traumatic brain injury, does CLEAR SPEECH compared to traditional speech therapy techniques result in greater improvements in speech intelligibility

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 10/9/2012)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12612000968875

Date registered

10 September 2012

Health condition

Non-progressive dysarthria, Stroke, Traumatic brain injury

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

21 August 2012

Ethics application status

Approved

Brief summary

Overall this research aims to determine whether or not CLEAR SPEECH is a viable treatment option for patients with non-progressive dysarthria. Specifically, this research project aims to:

1. Determine the efficacy of CLEAR SPEECH as a treatment for non-progressive dysarthria following stroke and TBI across a range of perceptual, acoustic and everyday communication outcome measures.

2. To compare the effects of CLEAR SPEECH with the outcomes of traditional dysarthria therapy (TRAD) in individuals with non- progressive dysarthria.

It is hypothesized that CLEAR SPEECH will result in short and long term improvements to perceptual and acoustic measures of speech function, and ratings of everyday communication in individuals with non-progressive dysarthria. Also, the degree of improvement in speech and communication parameters will be greater following CLEAR SPEECH compared to the effects achieved following TRAD.

Eligibility

Key inclusion criteria

To be eligible to participate in the study, participants will be required to be English speaking, have mild to severe non-progressive dysarthria as diagnosed by a speech pathologist, be 6 months post neurological incident, and have a cognitive status that is adequate to participate in assessment tasks. Prior to commencing the study participants will also undergo stimulability testing to assess whether they have the potential for improvements in speech clarity. Only potential participants who are able to demonstrate improvements for speech clarity will be included in the study.

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Potential participants will be excluded if, in addition to their dysarthria, they present with a co-morbid condition that may negatively impact on their ability to complete speech therapy. Such conditions include significant aphasia, hearing or vision loss, dementia, apraxia of speech, or post traumatic amnesia. Prior to inclusion in the study research personnel will screen all potential participants.

Contact details and further information

Primary Sponsor

Type: University
Name: The University of Queensland
Address: St Lucia
Queensland
4072
Country: Australia

Contact person for information and recruitment

Stacie Park
School of Health and Rehabilitation Sciences
Therapies Building
University of Queensland
St Lucia 4072
Australia
+61 422 102 094
stacie.park@uqconnect.edu.au



Trial from ANZCTR

Comparison of intravesical core temperature measurement via a temperature sensing bladder catheter with peripheral temperatures measured at tympanic, nasopharyngeal and axillary sites in critically ill adult patients with acute brain injury and sepsis.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 1/8/2012)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12612000803897

Date registered

01 August 2012

Health condition

Traumatic brain injury, Cardiac arrest, Stroke, Sepsis

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

16 April 2012

Ethics application status

Approved

Brief summary

The CELSIUS Study is a prospective observational study of temperature measurement in critically ill patients with acute brain injury and sepsis in Australia and New Zealand.
In these patients we are evaluating commonly used methods of temperature measurement (tympanic, axillary, nasopharyngeal) with assessment against a pragmatic gold standard of urinary bladder temperature (intravesical) measurement.

Eligibility

Key inclusion criteria

Either:

1. Mechanically ventilated patients admitted into the intensive care units with a traumatic brain injury, cardiac arrest or stroke within the first week of intensive care treatment following injury

Or:

2. Patients admitted with sepsis (body temperature greater or equal to 38.0 degrees Celsius and receiving antimicrobial therapy for a known or suspected infection) within the first week of intensive care treatment for sepsis

Minimum age

16 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

1. Patients under 16 years of age.

2. Patients for which informed consent is not provided from the patient or patient’s surrogate decision maker,(unless the ethics committee agree to waiving consent).

3. Patients for whom insertion (or replacement) of a urinary catheter is contraindicated (for example known history of urethral stricture of severe pelvic trauma with suspected urethral tear).

Contact details and further information

Primary Sponsor

Type: Hospital
Name: St George Hospital
Address: Intensive Care Unit
St George Hospital
Gray Street, Kogarah NSW 2217
Country: Australia

Contact person for information and recruitment

Dr Manoj Saxena
Intensive Care Unit
St George Hospital
Gray Street, Kogarah NSW 2217
Australia
+61 2 9113 3373
msaxena@georgeinstitute.org.au



Trial from ANZCTR

Changes in bone structure, lean mass, and glucose metabolism in people with stroke: a two year observation study

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 27/1/2012)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12612000123842

Date registered

25 January 2012

Health condition

Acute Stroke, bone structure and density, glucose metabolism

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 June 2010

Ethics application status

Approved

Brief summary

This study is observing changes which occur to bone density and structure, muscle mass, and glucose metabolism (the way that the body converts sugars to energy), after stroke. We are investigating how these outcomes are influenced by physical activity after stroke. This information will be used in future designs of rehabilitation programs aimed at improving stroke patients' health and recovery.

Eligibility

Key inclusion criteria

The inclusion criteria are (1) a diagnosis of hemispheric stroke , (2) onset of stroke <1 week, (3) medically stable, (4) unable to ambulate within the first week after stroke, (5) able to understand simple verbal commands.

Minimum age

50 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

(1) brainstem or cerebellar stroke, (2) previous stroke in addition to the current admission, (3) known type 1 or type 2 diabetes (4) neurological conditions other than stroke (e.g. Parkinson’s disease) (5) significant musculoskeletal condition impacting on function (e.g. amputation, severe arthritis), (6) current or recent use of bone resorption inhibitors

Contact details and further information

Primary Sponsor

Type: Other Collaborative groups
Name: Florey Neuroscience Institutes
Address: Melbourne Brain Centre
245 Burgundy St
Heidelberg
Victoria 3084
Country: Australia

Contact person for information and recruitment

Ms Karen Borschmann
Stroke Division
Florey Neuroscience Institutes
Melbourne Brain Centre
245 Burgundy St
Heidelberg 3084
Vic
Australia
+61 3 9035 7073
karenb@unimelb.edu.au



Trial from ANZCTR

Providing an early home visit for mild-moderate severity strokes and facilitated discharge with the South Metro Area Health Service (SMAHS) Rehabilitation in the Home (RITH) therapists reduces length of stay for stroke unit patients in Perth WA: a randomised control trial.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 6/12/2011)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611001243909

Date registered

06 December 2011

Health condition

Stroke rehabilitation, early supported discharge

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

20 November 2011

Ethics application status

Approved

Brief summary

Early Supported Discharge (ESD) rehabilitation is considered internationally as best practice in rehabilitation of mild and moderate strokes when transferring from hospital to home. At RPH there are approximately 500 admissions for stroke. This research study will undertake a randomised controlled trial comparing an early discharge strategy to that of normal care in 90 individuals with mild and moderate stroke admitted to Royal Perth Hospital. This research study is designed to optimise the rehabilitation processes and pathway of people who have recently had a stroke.

This study is a cost utility analysis of processes associated with the pathway of individuals admitted to RPH with mild or moderate stroke. The proposed change in model of care (ESD process) may have an impact on acute LOS and we would like to test the hypothesis that if there is a change that it will not detract from the long term functional outcomes nor satisfaction of the clients

Hypothesis:
H1: That the ESD strategy decreases LOS when compared to a matched cohort with no difference in functional outcomes at 6 and 12 months.

Eligibility

Key inclusion criteria

- Resident in SMAHS catchment area (postcode)
- admitted to RPH Stroke unit
- mild/mod stroke as assessed on the NIHSS
- eligible for RITH program as per RITH criteria (including exclusion criteria for safe home visiting).

Minimum age

16 Years

Maximum age

100 Years

Gender

Both males and females

Key exclusion criteria

- Known discharge destination not in the SMAHS RITH catchment area, i.e. rural patients
- Medically unstable for discharge to a home based service
- safety concerns for home visiting as per RITH SMAHS safe home visiting policy

Contact details and further information

Primary Sponsor

Type: Hospital
Name: Royal Perth Hosptial (RPH)
Address: RPH
wellington ST
Perth
WA 6000
Country: Australia

Contact person for information and recruitment

roslyn Jones
C/o
RITH RPH
RPH outpatients building
RPH
198 goderich st
Perth
WA 6000
Australia
+61864775152
roslyn.jones@health.wa.gov.au



Trial from ANZCTR

A multi-centre, prospective, randomised pilot study of intravenous minocycline, 200mg 12 hourly for 5 doses, compared with standard care, in patients with ischaemic stroke treated with intravenous tissue plasminogen activator (tPA). A strategy to reduce haemorrhagic transformation

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 29/7/2012)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611001053910

Date registered

07 October 2011

Health condition

Ischaemic stroke

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 November 2011

Ethics application status

Approved

Brief summary

Intravenous tissue plasmingen activator (tPA), is an approved therapy for ischaemic (clotting type) of stroke. A worrisome side effect of tPA is haemorrhagic transformation; ie bleeding into damaged brain tissue. This occurs in over 6% of stroke patients treated with tPA, and is associated with a mortality rate of approximately 50%. Minocycline, is an anti-biotic with properties that may protect brain tissue in stroke. Early studies confirm its safety in stroke patients. Animal experiments combining the two agents have shown reduction s in haemorrhage. The WAIMATSS study examines this combination in humans, with the aim being to reduce haemorrhage.

Eligibility

Key inclusion criteria

Subjects must meet the standard inclusion criteria for use of intravenous tPA, be at least 18 years of age and provide informed consent.

Minimum age

18 Years

Maximum age

80 Years

Gender

Both males and females

Key exclusion criteria

Standard exclusion criteria for routine use of tPA
The critera for excluding use of tPA, as per the WA protocol for administration of intravenous tPA are;

1. Uncertainty about time of stroke onset (eg. patients awakening from sleep)
2. Coma or severe obtundation with fixed eye deviation and complete hemiplegia
3. Hypertension: systolic blood pressure greater than or equal to 180mmHg; or diastolic blood pressure >110mmHg on repeated measures prior to study.
4. Clinical presentation suggestive of subarachnoid haemorrhage even if the CT scan is normal
5. Presumed septic embolus
6. Patient having received a heparin medication within the last 48 hours and has elevated APTT or has a known hereditary or acquired haemorrhagic diathesis (eg. INR or APTT greater than normal). Known lupus anticoagulant is not a contraindication to alteplase.
7. INR >1.5 Known advanced liver disease, advanced right heart failure, or anticoagulation, and INR > 1.5 (no need to wait for INR result in the absence of the former three conditions)
8. Known platelet count <100,000 uL
9. Serum glucose is < 2.8mmol/l or >22.0 mmol/l


Relative contra-indications;
1. Severe neurological impairment with NIHSS score >22
2. Age >80 years
3. CT evidence of extensive middle cerebral artery (MCA) territory infarction (sulcal effacement or blurring of grey-white junction in greater than 1/3 of MCA territory)
4. Stroke or serious head trauma within the past 3 months where the risks of bleeding are considered to outweigh the benefits of therapy
5. Major surgery within the last 14 days (consider intra-arterial thrombolysis)
6. Patient has known history of intracranial haemorrhage, subarachnoid haemorrhage, known intracranial arteriovenous malformation or previously known intracranial neoplasm such that, in the opinion of the clinician, the increased risk of intracranial bleeding would outweigh the potential benefits of treatment
7. Suspected recent (within 30 days) myocardial infarction
8. Recent (within 30 days) biopsy of a parenchymal organ or surgery that, in the opinion of the responsible clinician, would increase the risk of unmanageable (eg. uncontrolled by local pressure) bleeding
9. Recent (within 30 days) trauma with internal injuries or ulcerative wounds
10. Gastrointestinal or urinary tract haemorrhage within the last 30 days or any active or recent haemorrhage that, in the opinion of the responsible clinician, would increase the risk of unmanageable (eg by local pressure) bleeding
11. Arterial puncture at non-compressible site within the last 7 days
12. Concomitant serious, advanced or terminal illness or any other condition that, in the opinion of the responsible clinician would pose an unacceptable risk
13. Rapidly improving deficit
14. Seizure: If the presenting neurological deficit is deemed due to a seizure, do NOT give alteplase. If the presenting neurological deficit is related to ischaemia, consider alteplase as per protocol
15. Pregnancy is not an absolute contraindication. Consider referral for intra-arterial thrombolysis . (Pregnancy IS an exclusion criteria for WAIMATSS.)

Specific exclusion criteria for the trial;

1.Evidence of other significant CNS disease that interferes with assessment (eg tumor, multiple sclerosis)
2. Known allergy to tetracyclines/intolerance of minocycline.
3. Known systemic lupus erythrematosis
4. Idiopathic intracranial hypertension.
5. Concurrent treatment with Vitamin A or retinoids.
6. Participation in another clinical drug trial.
7. Known significant renal failure, CLcr < 30mL/min by the Crockoft-Gault equation.
8. Known significantly abnormal liver function tests (ALT > x3 ULN)
9. Known thrombocytopaenia < 100 x 109/L.
10. Concurrent infection (at enrolment) requiring antibiotic treatment.
11. Pregnancy
12. Severe stroke or other co-morbidities likely to result in the patient dying within a week.

Contact details and further information

Primary Sponsor

Type: Hospital
Name: Sir Charles Gairdner Hospital
Address: Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS WA 6009
Country: Australia

Contact person for information and recruitment

David Blacker
C/O Dept of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS WA 6009
Australia
+ 61 89346 3333
david.blacker@health.wa.gov.au



Trial from ANZCTR

Randomised trial of the effect of infant action observation training on the early development of hand reaching and grasping in healthy infants and in infants with early brain injury.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 16/9/2011)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000991910

Date registered

16 September 2011

Health condition

Asymmetric brain lesions, Venous infarction, Arterial stroke, Congenital hemiplegia

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

20 April 2010

Ethics application status

Approved

Brief summary

This project aims to explore, in a randomised trial, whether a novel training program based on the observation of hand action can influence the early development of hand reaching and grasping in healthy infants and infants with asymmetric brain injury. This study will compare Action Observation Training with standard Observation Training in a population of healthy term infants, as well as in a population of infants with asymmetric brain injury.

It is predicted that:
(1) Action Observation Training will improve the symmetry of bimanual hand function as measured on the Infant Hand Assesment at 18 weeks, compared to standard Observation Training; and
(2) Action Observation Training will have a greater impact on the quantity and quality of reaching and grasping of the impaired hand as measured on the Reach and Grasp Assessment at 18 weeks, compared to standard Observation Training.

Eligibility

Key inclusion criteria

Healthy term group:
- Gestational age at birth between 38 and 41 weeks
- Uncomplicated delivery
- Absence of post-natal complications
- Lives within 50km of RCH
- Parents willing and available to participate up to their baby’s 12mth assessment

Asymmetric brain lesion group:
- Presence of a unilateral or asymmetric brain damage (i.e. preterm or term arterial stroke, unilateral grade IV intraventricular haemorrhage, unilateral periventricular leukomalacia) on neonatal ultrasound or MRI
- Lives within 200km of RCH and could be visited at home

Minimum age

0 Years

Maximum age

9 Weeks

Gender

Both males and females

Key exclusion criteria

Healthy term group:
- a complicated delivery
- post-natal complications (e.g. asphyxia)

Asymmetric brain lesion group:
- epileptic seizures unresponsive to treatment

Contact details and further information

Primary Sponsor

Type: Individual
Name: Associate Professor Roslyn Boyd
Address: Queensland Cerebral Palsy and Rehabilitation Research Centre,
Level 7, Block 6, Royal Brisbane and Women's Hospital, Herston, QLD 4029
Country: Australia

Contact person for information and recruitment

Associate Professor Roslyn Boyd
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC),
Level 7, Block 6,
Royal Brisbane & Women's Hospital,
Cnr Butterfield and Bowen Bridge Rd,
Herston, QLD, 4029
Australia
+61434608443
r.boyd@uq.edu.au



Trial from ANZCTR

An Australasian, investigator-driven, NHMRC funded, multicentre, prospective randomised, parallel group, double-blind, placebo-controlled trial to establish the effect(s) of routine administration of fluoxetine (20mg once daily) in patients with recent stroke.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 21/12/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000774921

Date registered

22 July 2011

Health condition

Stroke

Recruitment countries

Australia, New Zealand, Viet Nam

Recruitment site location(s) (State)

Australian Capital Territory, New South Wales, Queensland, South Australia, Tasmania, Western Australia, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

20 September 2012

Ethics application status

Approved

Brief summary

Does routine administration of fluoxetine (20mg od) in the 6 months after acute stroke improve patients’ functional outcome?

Eligibility

Key inclusion criteria

Men or women aged 18 years or more with: - Clinical diagnosis of stroke 2-15 days previously (Day of stroke onset = Day 0, randomise on Day 2-15); - Brain imaging consistent with ischaemic or haemorrhagic (intracerebral and/or subarachnoid) stroke (including normal CT brain scan); - Persisting measurable focal neurological deficits (e.g. motor, somatosensory, visual, language, cognitive) present at randomisation and severe enough to produce a modified Rankin Scale (mRS) score of equal or > 1 and to warrant treatment from the perspective of patient or carer(s).

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Exclusion Criteria
Any of the following:
History of epileptic seizures
History of bipolar disorder
History of drug overdose or attempted suicide
Ongoing treatment with any selective serotonin reuptake inhibitor (SSRI)
Allergy or contra indication to fluoxetine including
Hepatic impairment (serum alanine aminotransferase [ALT] >120 U/l),
Renal impairment (creatinine >180micromol/l or eGFR < 30ml/min/1.73m2),
Hyponatremia (sodium <125mmol/L) despite treatment of the cause and confirmed on repeat testing,
Use of medications that may interact seriously with fluoxetine
Proposed use of a monoamine oxidase inhibitor (MAOI), or use of a MAOI within 14 days prior to randomisation
Current treatment with an antipsychotic drug (neuroleptic), pimozide, tamoxifen, or tramadol, unless the patient, doctor and if possible prescribing doctor, believe it is appropriate to discontinue use.
Not available for follow up over the next 365 days e.g. no fixed home address.
Life-threatening illness (e.g. advanced cancer) that is likely to reduce 365 day survival
Pregnant, breast-feeding or of child-bearing potential and not using contraception
Enrolled in another interventional clinical research trial involving an investigational product (medicine) or device

Contact details and further information

Primary Sponsor

Type: Hospital
Name: Sir Charles Gairdner Hospital
Address: Hospital Avenue
Nedlands
Perth, Western Australia
6009
Country: Australia

Contact person for information and recruitment

Mrs Anne Claxton
Faculty of Health and Medical Sciences
Medical School
QEII Medical Centre Unit (M503)
The University of Western Australia
Level 2, Harry Perkins Institute of Medical Research
6 Verdun Street
NEDLANDS WA 6009

Australia
+61 8 6151 1061
anne.claxton@health.wa.gov.au



Trial from ANZCTR

The effects of thrombolysis on communication and swallowing recovery in patients with an ischaemic stroke compared with non-thrombolysed patients

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 17/1/2019)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000767909

Date registered

21 July 2011

Health condition

stroke

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland

Recruitment status

Recruiting

Anticipated date of first participant enrolment

15 January 2011

Ethics application status

Approved

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.

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

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

Contact details and further information

Primary Sponsor

Type: Individual
Name: Emma Finch
Address: Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country: Australia

Contact person for information and recruitment

Dr Emma Finch
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Australia
+61 7 3896 3133
e.whiting@uq.edu.au



Trial from ANZCTR

Does the use of environmental enrichment following stroke increase activity levels: A feasibility study.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 21/6/2011)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000629932

Date registered

21 June 2011

Health condition

Stroke

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

22 April 2010

Ethics application status

Approved

Brief summary

An observational study to explore if stroke survivors exposed to an enriched environment during their rehabilitation stay, have greater activity levels than stroke survivors receiving rehabilitation in a typical rehabilitation ward (non enriched setting). It is hypothesised that exposure to an enriched environment will increase activity levels during non therapy times.

Eligibility

Key inclusion criteria

mRS > or equal to 2
able to follow one step commands
able to stand with the assistance of 2
no behavioural issues influencing the ability to participate in 'normal' rehabilitation

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Becomes acutely unwell, preventing participation in the rehabilitation process

Contact details and further information

Primary Sponsor

Type: University
Name: University of Newcastle
Address: University Drive
Callaghan
NSW
2308
Country: Australia

Contact person for information and recruitment

Heidi Janssen
THe Lodge Building
Lookout Rd
New Lambton Heights
NSW
2305
Australia
+61 (0)411114995
Heidi.Janssen@hnehealth.nsw.gov.au



Trial from ANZCTR

Role of Quantitative Electroencephalography (EEG) in diagnosis, prognostication and management of Acute Stroke

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 13/12/2011)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000611921

Date registered

15 June 2011

Health condition

Ischaemic stroke, Hemorrhagic Stroke

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 July 2011

Ethics application status

Approved

Brief summary

Stroke is a leading cause of death, disability and huge socio-economic burden. It is caused by reduced blood supply (acute ischaemic stroke = AIS) or bleeding in the brain (intracerebral haemorrhage = ICH). Clinical prognosis and management in the acute post-stroke period are vitally informed by neurological assessment and accurate characterisation of brain injury. It is known that stroke-affected brain regions generate abnormal electrical signals which can be detected with electroencephalography (EEG) using electrodes placed non-invasively on the head. Quantitative analyses of EEG (QEEG) have been utilised over the past decade in stroke and other patients. EEG has a significant advantage in that it is virtually without contraindication or side effects and can be continuously performed at the bedside. This enables QEEG to monitor response to treatments as well; especially in consonance with the current brain imaging techniques. However, despite mounting evidence, QEEG surprisingly remains relatively under-utilised in acute stroke patients. An apparent reason for this is that it is unclear which parameter(s) is able to predict the patient’s clinical outcome most precisely and; whether this varies with stroke sub-type or timing of EEG. Broadly, this research is intended to identify the optimal QEEG parameters (timing, frequency/amplitude vs. interhemispheric symmetry measures) for prognostication in AIS & ICH.

Eligibility

Key inclusion criteria

Patient presenting with acute stroke within 24 hours of onset of symptoms

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Patients under 18 years of age (RBWH primarily treats adult patients and data of use of EEG in stroke patients < 18 years of age is limited)

Pregnant patients (use of various investigations e.g., CT and treatments e.g., thrombolysis is limited in pregnancy)

Patients with previous craniotomy affecting the EEG electrode placement and signal recording

Any participant who is unable to (or declines to) consent for any reason or for whom consent from a substitute decision maker is unavailable or declined.

Contact details and further information

Primary Sponsor

Type: Hospital
Name: Royal Brisbane & Women's Hospital
Address: Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4029
Country: Australia

Contact person for information and recruitment

Dr. Nabeel Sheikh
Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4122
Australia
+61 7 3636 8111
Nabeel_Sheikh@health.qld.gov.au



Trial from ANZCTR

In acute, very weak stroke patients does electromyographic (EMG) triggered electrical stimulation increase strength and activity in the arm compared to conventional therapy alone?

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 23/3/2011)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000309987

Date registered

23 March 2011

Health condition

Stroke

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

02 July 2007

Ethics application status

Approved

Brief summary

People who have had a severe stroke generally remain very disabled. An EMG triggered electrical stimulation machine measures electrical activity in muscles and provides electrical stimulation when a threshold level of muscle activity is reached, hence it provides feedback to people with weak muscles and strengthens muscles. Seventy very weak, acute stroke patients will be allocated to receive EMG triggered electrical stimulation to muscles of their arm in addition to conventional therapy or conventional therapy only. Measures of muscle strength and activity will be taken before and after the intervention. This intervention has the potential to increase the likelihood of returning to independence after a severe stroke.

Eligibility

Key inclusion criteria

Diagnosis of stroke less than 4 weeks before, medically stable, no previous stroke with residual deficits, previously able to manipulate objects independently, less than grade 3 muscle strength in 3 out of 4 of the following muscle groups of the affected UL , shoulder flexors, elbow extensors, wrist extensors, thumb abductors, have sufficient cognition and communication to understand the purpose of the study and give informed consent.

Minimum age

50 Years

Maximum age

85 Years

Gender

Both males and females

Key exclusion criteria

Demand style cardiac pacemaker, severe receptive aphasia, previous stroke resulting in hemiplegia/ hemiparesis or any barriers to taking part in a physical rehabilitation programme.

Contact details and further information

Primary Sponsor

Type: University
Name: University of Sydney
Address: Faculty of Health Sciences
PO Box 170
Lidcombe
NSW 1825
Country: Australia

Contact person for information and recruitment

Ms Simone Dorsch
C/O Physiotherapy Department
Bankstown-Lidcombe Hospital
Eldridge Rd
Bankstown NSW 2200
Australia
61 414 811 168
simonedorsch@optusnet.com.au



Trial from ANZCTR

A randomised controlled trial to investigate the effectiveness of a model of integrated, evidence based management of modifiable cardiovascular risk factors and post stroke depression, in stroke survivors returning to the care of their general practitioner.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 31/3/2014)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000264987

Date registered

11 March 2011

Health condition

Stroke Prevention, Post stroke Depression

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

26 February 2008

Ethics application status

Approved

Brief summary

Stroke survivors can be faced with many problems including the physical disability resulting from the stroke, interruption and often cessation of gainful employment, disruption to family life and the onset of post stroke depression. Stroke survivors are also at a much higher risk of experiencing further stroke. Effective management of stroke risk factors including, high blood pressure, high cholesterol, smoking, excessive alcohol intake and obesity, can significantly reduce the likelihood of a recurrent stroke. However, there remains a considerable gap between published and evidence-based guidelines for stroke prevention and the reality of care received by stroke survivors.

The Integrated CAre for the RedUction of Secondary Stroke Project (ICARUSS) is an integrated, multi-modal model of care for the management of risk factors in stroke survivors that was developed from a shared care model. Its goal is to reduce mortality and disability by reducing the recurrence of stroke. Initial results of a pilot study suggest that it is practical, feasible and of great importance to stroke survivors, there carers, and the community in general. The model is now being tested on a broader scale throughout Australia.

Eligibility

Key inclusion criteria

1. Diagnosis of stroke (ischemic or hemorrhagic) or transient ischemic attack.
2. Returning to the care of the primary care physician upon discharge from acute care or rehabilitation.
3. Is able to provide informed consent.
4. 18 years of age or older

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

1. Diagnosed with dissection, subarachnoid hemorrhage, traumatic intracerebral hemorrhage or subdural hematoma.
2. Unable to return to the care of their primary care physician.
3. Unable to provide informed consent.

Contact details and further information

Primary Sponsor

Type: Charities/Societies/Foundations
Name: National Ageing Research Institute (NARI) of Melbourne.
Address: Gate 4, 34-54 Poplar Road Parkville Victoria 3052
Country: Australia

Contact person for information and recruitment

David Jackson
Department of Neurology
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Australia
Australia
+61 3 9342 7598
david.jackson@mh.org.au



Trial from ANZCTR

An international randomised controlled trial to compare the effects of low- and standard-dose recombinant tissue plasminogen activator (rtPA) and to establish the effects of early intensive blood pressure (BP) lowering on death and disability in patients with ischaemic stroke

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 2/7/2014)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12611000236998

Date registered

03 March 2011

Health condition

Ischaemic stroke, Hypertension

Recruitment countries

Australia, Hong Kong, United Kingdom, France, Austria, Swaziland, Italy, Portugal, Spain, China, New Zealand, Singapore, Korea, Republic Of, Viet Nam, India, Pakistan, Chile, Thailand

Recruitment site location(s) (State)

New South Wales

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 August 2011

Ethics application status

Approved

Brief summary

ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?

Eligibility

Key inclusion criteria

Patients with clinical diagnosis of acute ischaemic stroke confirmed by brain imaging within 4.5 hours of onset who fulfill local criteria for use of i.v. rtPA are potentially eligible if they have a sustained systolic BP level of 185 mmHg or below.
The attending clinician is required to sequentially consider their level of clinical uncertainty over the balance of potential benefits and risks pertaining to the appropriate dose of rtPA and the level of BP control in each particular patient, as outlined below.
Arm [A]: no definite indication/contraindication for either dose of rtPA; and able to pay for a 50mg vial of rtPA if in a fee-paying health system.
Arm [B]: will or has received thrombolysis treatment with rtPA, either randomised dose within the trial or physician decided dose rtPA outside of the trial; sustained elevated systolic BP level, defined as 2 readings 150 mmHg; able to commence intensive BP lowering treatment within 6 hours of stroke onset; able to receive either immediate intensive BP lowering or conservative BP management

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset; other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mRS scores 2-5)]; specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used; participation in another clinical trial involving evaluation of pharmacological agents; need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.

Contact details and further information

Primary Sponsor

Type: Other
Name: The George Institute for Global Health
Address: PO Box M201 Missenden Rd, Camperdown NSW2050
Country: Australia

Contact person for information and recruitment

Prof Craig Anderson
The George Institute for Global Health
PO Box M201 Missenden Rd, Camperdown NSW2050
Australia
+61 2 9993 4500
canderson@georgeinstitute.org.au



Trial from ANZCTR

The effects of static scanning training and mobility training on the functional mobility of people with hemianopia and/or unilateral visual neglect resulting from acquired brain injury resulting from a stroke

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 16/6/2010)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12610000494033

Date registered

16 June 2010

Health condition

Stroke, acquired brain injury, hemianopia

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 October 2008

Ethics application status

Approved

Brief summary

Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient.

This study aims to determine which treatment is more effective, a standardized dosage approach or individualized therapy in patients with homonymous hemianopia post stroke.

Eligibility

Key inclusion criteria

Diagnois of aquired brain injury occurring a minimum of 2 weeks and not exceeding 6 months
Left or right homonymous hemianopia
Have corrected vision of at least 6/18

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Score of less than 24 on the Mini Mental State Examination
Evidence of aphasia or poor english skills that significantly impact on understanding instructions

Contact details and further information

Primary Sponsor

Type: Charities/Societies/Foundations
Name: National Stroke Foundation
Address: Level 7, 461 Bourke Street
Melbourne VIC 3000
Country: Australia

Contact person for information and recruitment

Stacey George
Repatriation General Hospital
Department of Rehabilitation & Aged Care
Daws Road, Daw Park, SA, 5043
Australia
+61 8 8275 1103
stacey.george@health.sa.gov.au



Trial from ANZCTR

To test the hypothesis that ischaemic stroke patients selected with significant penumbral mismatch at 4.5 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous Tissue Plasminogen Activator (tPA) compared to placebo

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 4/2/2016)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12610000011088

Date registered

06 January 2010

Health condition

Stroke

Recruitment countries

Australia, Taiwan, Province Of China, Finland

Recruitment site location(s) (State)

New South Wales, Queensland, South Australia, Western Australia, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

10 January 2010

Ethics application status

Approved

Brief summary

Primary Hypothesis: Patients selected with significant penumbral mismatch 4.5-9 hours post onset ischemic stroke given intravenous tPA will have improved clinical outcomes compared to those who have been given placebo. Secondary Hypotheses: 1. An increased risk of post-stroke depression will be predicted by biological markers related to stress and 5-HTTLPR genotype. 2. Increased risk of post-stroke depression will be predicted by an increase in proinflammatory biomarkers (i.e. cytokines and C-reactive protein) and APOE genotype, particularly in those who do not receive thrombolysis. 3. Diet and lifestyle factors, involving i) increase in lipid concentrations and decrease in vitamin B12 concentrations; ii) low activity levels; and iii) reduced participation in daily activities; will be associated with the presence and severity of depressive symptoms, recurrent stroke and functional outcome.

Eligibility

Key inclusion criteria

1. Patients presenting with hemispheric acute ischaemic stroke 2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent 3. Patient’s age is >=18 years 4. Treatment onset can commence within 4.5 – 9 hours after stroke onset according to registered product information, or between 3 – 9 hours according to locally accepted guidelines 5. Patients who wake with stroke may be included if neurological and other exclusion criteria are satisfied. These ‘wake up’ strokes are defined as having no symptoms at sleep onset, but stroke symptoms on waking. The time of stroke onset is to be taken as the mid-point between sleep onset (or last known to be normal) and time of waking. The maximum time window for randomisation is then 9 hours from the mid-point as described. 6. NIHSS score of >=4 - 26 with clinical signs of hemispheric infarction. 7. Penumbral imaging** –Using a Tmax>6 second delay, a perfusion (PWI) volume to diffusion (DWI) volume ratio of > 1.2, a DWI lesion <=70ml and PWI-DWI difference of >10ml ** Patients may be consented before or after penumbral screening depending upon local practice. The entire cohort of patients consented onto the study will be followed up with clinical assessments and biomarker studies regardless of eligibility for randomisation to treatment based on penumbral mismatch criteria.

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

1. Intracranial haemorrhage (ICH) identified by computed tomography (CT) or Magnetic Resonance Imaging (MRI) 2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of < 4 at randomization 3. Pre-stroke MRS score of >=2 (indicating previous disability) 4. Contra indication to imaging with MR with contrast agents 5. Infarct core >1/3 Middle Cerebral Artery (MCA) territory qualitatively 6. Participation in any investigational study in the previous 30 days 7. Any terminal illness such that patient would not be expected to survive more than 1 year 8. Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as haemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the Investigator. 9. Pregnant women (clinically evident) 10. Previous stroke within last three months 11. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator. 12. Current use of oral anticoagulants and a prolonged International Normalized Ratio (INR) > 1.6 13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range. 14. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) prior to study entry is permitted. 15. Clinically significant hypoglycaemia. 16. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of “aggressive treatment” is left to the discretion of the responsible Investigator. 17. Hereditary or acquired haemorrhagic diathesis 18. Gastrointestinal or urinary bleeding within the preceding 21 days 19. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator. 20. Exposure to a thrombolytic agent within the previous 72 hours

Contact details and further information

Primary Sponsor

Type: Other Collaborative groups
Name: National Stroke Research Institute
Address: The Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg VIC 3084
Country: Australia

Contact person for information and recruitment

Ms Elise Cowley
Neuroscience Trials Australia
The Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg VIC 3084
Australia
+61 3 9035 7232
ecowley@neurotrialsaustralia.com



Trial from ANZCTR

The effect of robot assisted upper limb therapy compared to usual care on upper limb improvements following stroke

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 7/9/2009)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12609000777291

Date registered

07 September 2009

Health condition

Stroke

Recruitment countries

Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

07 September 2009

Ethics application status

Approved

Brief summary

The purpose of the study is to gain information on the effectiveness of the use of robotics as a type of treatment for the recovery of movement of the upper limb (arm) for clients following a stroke. It specifically investigates whether the use of this particular robotic (Bimanutrack) in therapy, results in improved arm function following a stroke.

Eligibility

Key inclusion criteria

Diagnosis of stroke
No premorbid neurological deficits
Sufficient receptive and expressive language and cognitive ability to understand the study and provide consent
Sufficient sitting balance to use the robotic
Motor power grade of 3 or less in wrist flexion/extension and /or elbow pronation/supination.

Minimum age

18 Years

Maximum age

0 No limit

Gender

Both males and females

Key exclusion criteria

Upper limb contractures
Significant increased tone (Modified Ashworth Scale =4)
Active arthritis in finger, elbow or wrist joints
Shoulder-hand syndrome

Contact details and further information

Primary Sponsor

Type: Individual
Name: Sharyn Chaplin
Address: Daws Rd, Daw Park, South Australia 5041
Country: Australia

Contact person for information and recruitment

Sharyn Chaplin
Repatriation General Hospital
Daws Rd, Daw Park, South Australia 5041
Australia
+61 8 8275 1710
Sharyn.Chaplin@health.sa.gov.au