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A Very Early Rehabilitation Trial (AVERT)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01846247
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : April 15, 2015
Singhealth Foundation
Chest, Heart and Stroke Association Scotland
Northern Ireland Chest Heart and Stroke
The Stroke Association - UK
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Neuroscience Trials Australia

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Standard Care + VEM Other: Standard care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2014 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicentre, Randomised Controlled Trial of Very Early Rehabilitation After Stroke.
Study Start Date : June 2006
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Placebo Comparator: Standard Care
Standard stroke unit rehabilitation care
Other: Standard care
Experimental: Standard Care + VEM
Standard stroke unit rehabilitation care in addition to a very early rehabilitation protocol
Other: Standard Care + VEM
Patient will receive standard stroke unit care with earlier and additional physiotherapy and nursing sessions as per an intervention protocol.

Primary Outcome Measures :
  1. modified Rankin Score [ Time Frame: 3 months ]
    Favorable outcome (0-2) modified Rankin Score

Secondary Outcome Measures :
  1. 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.

  2. 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. modified Rankin Score [ Time Frame: 3 months ]
    Assumption free ordinal approach

  4. Health related Quality of life [ Time Frame: 12 months ]

  5. Cost effectiveness and cost utility [ Time Frame: 12 months ]
    comprehensive questionaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01846247

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Australia, Victoria
Florey Institute for Neuroscience and Mental health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Neuroscience Trials Australia
Singhealth Foundation
Chest, Heart and Stroke Association Scotland
Northern Ireland Chest Heart and Stroke
The Stroke Association - UK
National Institute for Health Research, United Kingdom
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Neuroscience Trials Australia Identifier: NCT01846247     History of Changes
Other Study ID Numbers: version3 25April08
ACTRN12606000185561 ( Registry Identifier: ANZCTR )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Neuroscience Trials Australia:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases