Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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

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.
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
Government body
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
Government body
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/study/NCT01846247
Trial related presentations / publications
Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
Sheppard L, Dewey H, Bernhardt J, Collier JM, Ellery F, Churilov L, Tay-Teo K, Wu O, Moodie M; AVERT Trial Collaboration Group. Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care. Int J Stroke. 2016 Jun;11(4):492-4. doi: 10.1177/1747493016632254. Epub 2016 Mar 2.
Bernhardt J, Raffelt A, Churilov L, Lindley RI, Speare S, Ancliffe J, Katijjahbe MA, Hameed S, Lennon S, McRae A, Tan D, Quiney J, Williamson HC, Collier J, Dewey HM, Donnan GA, Langhorne P, Thrift AG; AVERT Trialists' Collaboration. Exploring threats to generalisability in a large international rehabilitation trial (AVERT). BMJ Open. 2015 Aug 17;5(8):e008378. doi: 10.1136/bmjopen-2015-008378.
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/study/NCT01846247