AVERT
A Very Early Rehabilitation Trial
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Status:
Ongoing. Trial began in July 2006 and is currently recruiting subjects with 509 enrolled as of August 2009 and a recruitment period of 3.5 years expected.
Purpose:
To determine if very early mobilization (VEM) of stroke patients in addition to standard care compared to standard care (SC) alone is more effective in lowering mortality, disability, and severity of complications at 3 months and at improving quality of life at 12 months.
Location(s):
Australia, Canada, New Zealand, Scotland, Singapore, & Wales
Year Started:
2006
Design:
Multicenter, randomized, controlled trial.
Inclusion Criteria
Patients with first or recurrent stroke diagnosis, hemorrhage or infarct, within 24 hours of onset of symptoms admitted directly to stroke unit from emergency room. Consciousness: Must at least react to verbal commands.
Exclusion Criteria
Pre-stroke (retrospective) modified Rankin Score of 3, 4 or 5 (indicating significant previous disability). Deterioration in patient’s condition in the first hour of admission resulting in direct admission to ICU, a documented clinical decision for palliative treatment (e.g. those with devastating stroke) or immediate surgery. Concurrent diagnosis of rapidly deteriorating disease (e.g. terminal cancer). Unstable coronary or other medical condition that is judged by the investigator to impose a hazard to the patient by involvement in the trial. A suspected or confirmed lower limb fracture at the time of stroke preventing the implementation of the mobilization protocol.
Patients who have received rt-PA can be recruited if the attending physician permits and if mobilization within 24 hours of stroke is permitted. Patients cannot be concurrently recruited to drug or other intervention trials. Patients may participate in AVERT if they are also recruited to non intervention trials. Systolic blood pressure 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 C.
Patient Involvement:
Patients will be randomized into one of two groups: the Standard Care (SC) group is usual stroke unit care, or to the treatment group of Very Early Mobilization (VEM). The VEM group receive additional mobilization sessions (physiotherapy and nursing)over the intervention period of 14 days, or until the patient is discharged from stroke unit care, whichever is sooner. VEM is provided by trained physiotherapy and nursing staff according to a detailed protocol, and patients are carefully monitored for any adverse events.
Primary Outcome:
Modified Rankin Score at 3 months.
Secondary Outcome:
Safety: Mortality rate and the rate and severity of important medical events (stroke progression, recurrent stroke, falls, angina, myocardial infarctions, deep venous thromboses, pulmonary emboli, pressure sores, chest infections, urinary tract infections) at 3 months; and all adverse events during the intervention period. Health-related quality of life: cognitive function using Montreal Cognitive Assessment (MoCA) at 3 months: Assessment of Quality of Life and Irritability, Depression and Anxiety scale; at 3 and 12 months. Cost effectiveness and cost utility: Comprehensive questionnaire at 3 and 12 months and baseline mRS. Long term efficacy: mRS at 12 months. Activity limitations: Time to walking 50 metres; Rivermead Motor Assessment and Barthel Index at 3 and 12 months. Dose-response: Intervention dose and Modified Rankin Score at 3 and 12 months. Patient severity and efficacy: Mild, moderate and severe stroke (NIHSS) and mRS at 3 and 12 months.
Results:
The early stages of this large phase III trial of early stroke mobilization have been successfully completed. In order to achieve the required sample size we are currently working on recruiting some additional local sites and a small number of international sites.
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Source of Information:
Correspondence with trial coordinator.
Source: A Very Early Rehabilitation Trial for Stroke (AVERT): Phase II Safety and Feasibility
Stroke, Feb 2008; 39: 390 - 396. http://stroke.ahajournals.org/strokeasap.shtml
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Web Links and Publications:
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This information last updated on: 8/10/2009
Reviewed on: 01/26/2010.
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