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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01846247




Registration number
NCT01846247
Ethics application status
Date submitted
30/04/2013
Date registered
3/05/2013
Date last updated
15/04/2015

Titles & IDs
Public title
A Very Early Rehabilitation Trial
Scientific title
A Phase 3, Multicentre, Randomised Controlled Trial of Very Early Rehabilitation After Stroke.
Secondary ID [1] 0 0
ACTRN12606000185561
Secondary ID [2] 0 0
version3 25April08
Universal Trial Number (UTN)
Trial acronym
AVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standard Care + VEM
Other interventions - Standard care

Placebo Comparator: Standard Care - Standard stroke unit rehabilitation care

Experimental: Standard Care + VEM - Standard stroke unit rehabilitation care in addition to a very early rehabilitation protocol


Other interventions: Standard Care + VEM
Patient will receive standard stroke unit care with earlier and additional physiotherapy and nursing sessions as per an intervention protocol.

Other interventions: Standard care
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
modified Rankin Score
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Safety. Death rate and severity of important medical events
Timepoint [1] 0 0
up until 3 months
Secondary outcome [2] 0 0
Time to unassisted walking over 50 meters and the proportion achieving unassisted walking
Timepoint [2] 0 0
3 Months
Secondary outcome [3] 0 0
modified Rankin Score
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Health related Quality of life
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Cost effectiveness and cost utility
Timepoint [5] 0 0
12 months

Eligibility
Key inclusion criteria
- Informed consent

- Clinical diagnosis of first or recurrent stroke, hemorrhage or infarct.

- Recruited within 24 hours of onset of stroke symptoms

- Admission in a stroke care unit

- Consciousness: At a minimum patient must at least react to verbal commands.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- pre stroke mRS of 3,4 or 5

- Deterioration in patients condition resulting in direct admission to ICU, decision to
palliate or surgery.

- Concurrent diagnosis of rapidly deteriorating disease

- Unstable coronary or other medical condition that is judged by the investigator to
impose a hazard to the patient by involvement

- Patients unable to be mobilized within 24 hours of onset. (eg bed rest policy post
tPA, lower limb fracture)

- Other interventional trials

- Systolic BP less than 110 or greater than 220mmHg

- Oxygen saturation of less than 92 % with supplementation

- Resting heart rate of less than 40 or greater than 110 beats per minute

- Temperature of greater than 38.5 degrees C

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
2014
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Florey Institute for Neuroscience and Mental health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Singhealth Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Chest, Heart and Stroke Association Scotland
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Northern Ireland Chest Heart and Stroke
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Stroke Association - UK
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
National Institute for Health Research, United Kingdom
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Phase 3, multicenter, international randomized controlled trial of a Very Early
Mobilization(VEM) care rehabilitation protocol compared to standard post stroke care (SC).
Participants receive either SC and VEM or SC alone in the acute phase of stroke up to a
period of 14 days.

Participants are followed up by a blinded assessor at 3 and 12 months post stroke to
determine trial outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01846247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julie Bernhardt, PhD
Address 0 0
The Florey Institute of Neuroscience and Mental Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01846247