AVERT DOSE | Determining the most effective mobility training program early after stroke
Ongoing uncertainty around the world about the safest and most effective early training approaches after stroke prompted this clinical trial. Using our global network of acute hospitals treating people with stroke, we’ll recruit more than 2,500 patients from over 50 hospitals in Australia, New Zealand, United Kingdom, India, Taiwan, Singapore and Malaysia into the study, testing a range of evidence-informed mobility-based treatment protocols to determine the optimal approach. Physiotherapists and nurses deliver the training, starting within 48 hours of stroke, throughout the patient’s acute stay or 14 days (whichever is sooner).
We’re using a new trial design approach called an adaptive clinical trial (full name; multi-arm, multi-stage, covariate-adjusted, response-adaptive randomised clinical trial). The design means that as the trial progresses and the outcomes for each person are known, an algorithm that controls where new patients are randomly allocated adjusts to favour recruitment into the treatments that show the most promise. Recruitment commenced in 2019 and with the assistance of over 2,500 volunteers we expect to have the information we need to roll out new evidence-based training protocols by 2023.
This trial was developed by Professor Julie Bernhardt and a large team of collaborators. Full scientific details of the trial protocol are at the Australian New Zealand Clinical Trials Registry. Additional sub-studies will be completed as a part of the trial. We want to understand the relationships between genetics, brain markers (using diffusion tensor imaging), and other brain tests (motor evoked potential) and recovery. We’re interested in pre-stroke factors including physical activity and work and life experience (cognitive reserve) and outcome following stroke. We’ll also gather data that allows us to study the cost-effectiveness of the intervention. Grant funding has been awarded by the Australian National Health and Medical Research Council (#1139712).
Further trial information can be found on twitter: @AVERTDOSEtrial.
- Professor Leonid Churilov, Melbourne Medical School, University of Melbourne
- Professor Peter Langhorne, Institute of Cardiovascular and Medical Sciences, University of Glasgow
- Professor Jeyaraj Pandian, Department of Neurology, Christian Medical College, Ludhiana, India
- Professor Helen Dewey, Eastern Health Clinical School, Monash University
- Professor Velandrai Shrikanth, Peninsula Clinical School, Monash University
- Associate Professor Coralie English, School of Health Sciences and Priority Research Centre for Stroke and Brain Injury University of Newcastle
- Professor Marj Moodie, Deakin Health Economics, Deakin University
- Professor Sandy Middleton, Nursing Research Institute, Australian Catholic University
- Professor Amanda Thrift, Department of Medicine – School of Clinical Sciences, Monash University
- Ms Anna McRae, Allied Health, Auckland District Health Board, Auckland
- Professor Bent Indredavik, Norwegian University of Science And Technology, The Institute for Neuromedicine, Trondheim, Norway
- Dr Dawn Tan, Physiotherapy Department, Singapore General Hospital
- Dr Julie Luker, Sansom Institute for Health Research, University of South Australia
- Ms Katijjah Md Ali, Department of Physiotherapy, Hospital Canselor Tuanku Muhriz, Kuala Lumur, Malaysia
- Professor Richard Lindley, Sydney Medical School, University of Sydney
- Professor Geoffrey Donnan, Melbourne Brain Institute, University of Melbourne
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- Lio, T. S., Uetake, S., Bates, T. R., Bernhardt, J., and on behalf of the AVERT Dose Trials’ Collaboration (2021). An Australian stroke unit team’s experience of recruitment to the AVERT DOSE trial during the COVID-19 pandemic. International Journal of Stroke, 16 (1S), 19. Poster. doi:10.1177/17474930211036296
- Bernhardt J, et al on behalf of the AVERT trial collaboration (2015), ‘Efficacy and safety of very early mobilisation after stroke (AVERT): a randomised controlled trial’, The Lancet, 386(9988):46-55. DOI: http://dx.doi.org/10.1016/S0140-6736(15)60690-0