- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846247
A Very Early Rehabilitation Trial (AVERT)
A Phase 3, Multicentre, Randomised Controlled Trial of Very Early Rehabilitation After Stroke.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People who suffer a stroke are often left with disabilities such as weakness, or problems with speech, thinking, or control or bodily functions. Severe strokes often result in death. The results of a recent European study indicated that patients who commence mobility training very early after a stroke (Day 1) recover the ability to walk more quickly and return home sooner and in greater numbers than those who start training one week or later after stroke. Recently a phase II (pilot) AVERT study was conducted in which the investigators tested the safety and feasibility of very early mobilisation (European model) Stroke patients in this study randomly received either standard care or very early mobilisation (VEM). The study showed that there was no harm to patients in the VEM group compared to those who had standard care and that delivering VEM was feasible. Consequently, a grant to conduct the larger phase III study, to test the effectiveness of the intervention was obtained.
In this next phase III trial, the investigators aim to look at 2104 patients across stroke care units in city and regional hospitals. Each hospital will be asked to include between 30 and 60 patients per year to the study. All stroke patients admitted to the hospital Stroke Unit or ward at the hospital will be invited to participate. Medical clearance will be obtained for all potential participants. Those unconscious or too ill, together with those already participating in acute drug trials will be excluded. Patients who are able will provide their own consent to participate. Those who are not able to consent for themselves will have a third party (usually a relative) acknowledge their participation in the study. As this is a blinded controlled trial, keeping the assessor and patients unaware of their treatment group is important. The investigators will inform patients that they will have a 50% chance of receiving one of two rehabilitation types during their hospitalization if they decide to participate. Patients in the VEM group will commence treatment within 24 hours of admission to hospital. VEM will be provided by a trained AVERT physiotherapist, and AVERT study nurse and aims to improve functional mobility. The mobilization activities will depend on the patient's functional ability and tolerance to exercise. Patients will be closely monitored prior to mobilization and will only be mobilised if they meet requirements for blood pressure and other vital signs. The number of sessions and the time spent for each patient will vary, however specific targets are to be met according to the intervention protocol. The content and timing of all treatment received by participants in either group will be recorded. The treatment period for this study is from the time of the patients consent, until day 14 or discharge from the stroke unit or ward. (Whichever is earlier). All participants will be assessed at admission to the study, 3 months, and 12 months after their stroke. Information collected by the AVERT physiotherapists and nurses and the assessor will be recorded on individual case record forms and on a secure web based data base. Therapists also add some information to a palm pilot, and then download it onto the secure website. All information collected from patients will be treated as confidential in line with international guidelines and local law.
The primary outcome measure for the study is the number of patients dead and disabled at 3 months after stroke. Other secondary outcome measures include the safety of patients, quality of life, and cost effectiveness. An independent Data Monitoring committee will monitor the safety, conduct and efficacy of the trial. In addition, an independent outcomes committee will be reviewing all events that are reported as serious.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3084
- Florey Institute for Neuroscience and Mental health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Patient will receive standard stroke unit care with earlier and additional physiotherapy and nursing sessions as per an intervention protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified Rankin Score
Time Frame: 3 months
|
Favorable outcome (0-2) modified Rankin Score
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety. Death rate and severity of important medical events
Time Frame: up until 3 months
|
Important medical events (stroke progression, recurrent stroke, falls, angina, myocardial infarction, deep vein thrombosis, pulmonary emboli, pressure sores, chest infections, urinary tract infections, depression) at 3 months.
|
up until 3 months
|
Time to unassisted walking over 50 meters and the proportion achieving unassisted walking
Time Frame: 3 Months
|
Achieves walking independently or with supervision over 50 meters
|
3 Months
|
modified Rankin Score
Time Frame: 3 months
|
Assumption free ordinal approach
|
3 months
|
Health related Quality of life
Time Frame: 12 months
|
AQoL
|
12 months
|
Cost effectiveness and cost utility
Time Frame: 12 months
|
comprehensive questionaire
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Julie Bernhardt, PhD, The Florey Institute of Neuroscience and Mental Health
- Principal Investigator: Leonid Churilov, PhD, The Florey Institute of Neuroscience and Mental Health
- Principal Investigator: Helen Dewey, MD, Monash University
- Principal Investigator: Richard Lindley Dewey, MD, George Institute for Global Health
- Principal Investigator: Janice Collier, PhD, The Florey Institute of Neuroscience and Mental Health
- Principal Investigator: Amanda Thrift, PhD, Monash University
- Principal Investigator: Geoffrey Donnan, MD, The Florey Institute of Neuroscience and Mental Health
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- version3 25April08
- ACTRN12606000185561 (Registry Identifier: ANZCTR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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