Reducing both the personal and community burden of stroke is a primary driver of the very early rehabilitation research program. Our research program has the largest randomised controlled trial of very early rehabilitation (AVERT) at its core. We aim to establish the efficacy, cost effectiveness and potential mechanisms of very early rehabilitation.
Key development objectives are to
Enquiries about VER can be directed to the principal investigator, Dr Julie Bernhardt at avert@nsri.org.au.
A Very Early Rehabilitation Trial (AVERT): Phase 1
Bernhardt J, Dewey HM, Thrift AG, Donnan GA
Coordinating centre: National Stroke Research Institute
Participating centres: Patients and staff from stroke units at the Austin Hospital, Alfred Hospital, Royal Melbourne Hospital, St. Vincent's Hospital, and Western Hospital Melbourne, Australia.
Background: There is clear evidence that treatment in acute stroke units improves outcome, however, we know little about the components of care responsible for better outcomes.
Aims: To (i) document the level of physical activity in the acute stroke care unit; and (ii) examine the involvement of others on the physical activity of patients.
Study Design: Open observational study of patient activity and therapist report of patient interventions. A survey of stroke unit resources was also undertaken.
Method: Five metropolitan Melbourne stroke units participated. People less than 14 days from stroke onset and receiving an active therapy program were recruited. Ethics approval was obtained from each centre. Open observational behavioral mapping every 10 minutes for two consecutive therapeutic days from 08:00 to 17:00. Up to 25 categories were recorded at each observation period, including people present, location of activity and nature of activity. Treating therapists (physiotherapist, occupational therapists and speech therapists) provided a log of therapy preformed over both observation days. Senior staff completed a survey of stroke unit staffing resources.
Results and discussion can be obtained from publications (see below). The AVERT Phase 1 project was completed in December 2004.
Funding for this project was obtained from an NH&MRC Post Doctoral Fellowship (Julie Bernhardt) and an Austin Hospital Medical Research Fund seeding grant.
The following publications have arisen from this study to date:
- Bernhardt J, Dewey HM, Thrift AG, Donnan GA. Inactive and alone: Physical activity in the first 14 days of acute stroke unit care. Stroke. 2004; 35: 1005-1009.
- Bernhardt J, Chan J, Nicola I, Collier JM. Little therapy, little physical activity: Rehabilitation within the first 14 days of organised stroke unit care. Journal of Rehabilitation Medicine. In press, accepted 19/04/2006.
Enquiries about AVERT Phase 1 can be directed to the principal investigator, Dr Julie Bernhardt at avert@nsri.org.au.
A Very Early Rehabilitation Trial (AVERT): Phase 2
Bernhardt J, Dewey HM, Thrift AG, Donnan GA
Coordinating centre: National Stroke Research Institute
Participating centres: Patients and staff from stroke units at Austin Health and St. Vincent's Hospital, Melbourne, Australia.
Background: Very early rehabilitation, with an emphasis on mobilisation, may contribute to improved outcomes following stroke.
Aims: To evaluate the safety and feasibility of a very early rehabilitation (AVERT) protocol for patients managed in acute stroke units.
Study Design: A randomised controlled trial with concealed allocation, blinded assessment and intention to treat analysis.
Method: Patients less than 24 hours post stroke were recruited from two Melbourne metropolitan stroke units. Patients were randomly assigned to standard care or very early rehabilitation until discharge or 14 days (whichever was least). The primary safety outcome was the number of deaths at 3 months. Secondary safety outcomes were the rate of falls during the intervention period, failure to comply with physiological monitoring criteria and patient fatigue. Safety and efficacy outcomes were recorded at day 7, day 14, 3, 6 and 12 months.
Results and discussion: Recuitment ceased in February 2006, with 12 month follow-ups to be completed in February 2007.
Projects in development
- Rehabilitation within 24 hours of stroke (AVERT). Results of a randomised Phase 2 trial. J Bernhardt, HM Dewey, AG Thrift, J Collier, GA Donnan.
- Recovery in the first 14 days after stroke. A Lau, JM Collier, K Dodd J Bernhardt.
- The effect of very early mobilisation on complications after stroke. D Sorbello, J Bernhardt, K Dodd, JM Collier.
- Contamination of standard stroke unit care during a clinical trial. J Bernhardt, J Collier.
Predictors of recovery of walking following stroke
- Relationship between early rehabilitation and quality of life during the acute post stroke phase of care.
- Relationship between early rehabilitation and mood during the acute post stroke phase of care.
- Changes to the ischaemic penumbra during standard care and very early rehabilitation.
- The relationship between schedule of therapy and stroke outcome at 3 months.
- The therapy schedule and perceived fatigue in acute stroke patients.
Funding for this project was obtained from an NH&MRC Post Doctoral Fellowship (Julie Bernhardt), Austin Health and Medical Research Foundation, National Heart Foundation, Affinity Health and Perpetual Trustees.
Enquiries about AVERT Phase 2 can be directed to the principal investigator, Dr Julie Bernhardt at avert@nsri.org.au.
A Very Early Rehabilitation Trial (AVERT): Protocol Synopsis Phase 3
Dewey HM, Bernhardt J, Donnan GA, Thrift AG, Carter R, Lindley R,
Coordinating centre: National Stroke Research Institute
Participating centres: To be confirmed.
Publication:
Bernhardt J, Dewey H, Collier J, Thrift A, Lindley R, Moodie M, Donnan G. A Very Early Rehabilitation Trial (AVERT). International Journal of Stroke 1:169-171.
Projects in development
Health Economics - Validation of an early modified Rankin Score after stroke. H Zhao, J Bernhardt, JM Collier.
A comprehensive cost effectiveness study requires change scores on QOL measure. This study is required to determine whether the modified Rankin Scale can be employed day 0 post stroke.
Nursing - Nurses attitudes to involvement in research: Identifying barriers and solutions. This study will employ qualitative and quantitative methods to examine the evolution of attitudes to participation in research throughout the conduct of the very early rehabilitation trial.
Clinical Research - Physiological changes in response to very early rehabilitation compared to standard care.
Clinical Research - Does very early rehabilitation reduce lower limb spasticity and muscle length changes early after stroke?
Basic Science - Examining the effect of the timing and scheduling of exercise on functional and anatomical outcomes using a rat stroke model.
Funding for this project has been obtained from the Australian National Health and Medical Research Council.
Enquiries about AVERT Phase 3 can be directed to the principal investigator, Dr Julie Bernhardt at avert@nsri.org.au.
What is very early stroke unit rehabilitation? A comparison of physical activity patterns in Melbourne, Australia and Trondheim, Norway
Bernhardt, N Chitravas, I Lidarende, A Thrift, B Indredavik
Coordinating centre: National Stroke Research Institute
Participating centres: Patients and staff from stroke units in Melbourne Australia (Austin Hospital, Alfred Hospital, Royal Melbourne Hospital, St. Vincent's Hospital, and Western Hospital Melbourne) and Trondheim, Norway (St. Olav’s Hospital).
Background: It has been shown that very early mobilisation may be an important cause of the very favourable results of stroke unit care in Trondheim, Norway.
Aim: To (1) describe and compare the pattern of physical activity of stroke patients between stroke units in Trondheim and Melbourne; and (2) identify differences in activity according to stroke severity between the two sites.
Study Design: Between groups comparison.
Methods: Melbourne patients were recruited from five metropolitan stroke units Trondheim patients were recruited from the stroke unit at University Hospital, Trondheim. People less than 14 days from stroke onset and receiving an active therapy program were recruited. Ethics approval was obtained from each centre. Open observational behavioural mapping every 10 minutes over a single therapeutic day from 08:00 to 17:00. Up to 25 categories were recorded at each observation period, including people present, location of activity and nature of activity. Treating therapists (physiotherapist, occupational therapists and speech therapists) provided a log of therapy preformed over both observation days. Senior staff completed a survey of stroke unit staffing resources. Logistic regression analyses were undertaken to assess differences in physical activity patterns between stroke units in the two cities.
Results and discussion are underway.
Funding: NH&MRC of Australia (157305), an Austin Hospital Medical Research Fund seeding grant, and travel grants from the Ian Potter Foundation and the Stroke Society of Australasia.
Enquiries about this study can be directed to the principal investigator, Dr Julie Bernhardt at avert@nsri.org.au.
COLLABORATION WORKS! LINKING STROKE RESEARCHERS AND SOFTWARE ENGINEERING STUDENTS TO CREATE AVERT ONLINE
The AVERT Online Team
Coordinating centres: National Stroke Research Institute*, RMIT University†
The AVERT Online Team: Jesse Jackson†, Edwin Leong†, Tommy Li†, Naomi O’Neil†, Alan Ta†, Janice Collier*, Li Chun Quang*, Julie Bernhardt*
Background: AVERT (A Very Early Rehabilitation Trial) Phase 3 is an investigator driven, multicentre, randomised controlled trial of very early rehabilitation. Trial quality depends on effective and efficient systems for randomisation, data collection and communication across multiple hospital sites. As a trial with a big agenda but a small budget, we needed to find creative ways of developing the information technology trial resources. We approached RMIT University to help develop AVERT Online, a web-based system for trial administration.
Method: Five software engineering students developed AVERT Online as part of their final year elective. AVERT Online uses a centralised web portal accessible through an Internet browser. It consists of an intuitive patient management user interface, online address book for effective communications, reminder module to assist in administrative tasks and an automated import module for acquiring trial data from external sources. Summary reports can also be generated on trial progress.
Results and Conclusions: The system design and user interface are complete. Final testing is underway. AVERT Online will be deployed in July 2006 for the very early rehabilation trial, Phase 3. This collaboration has produced a vital tool for AVERT and provided valuable industry experience for students who have used industry best practice for software development.
Enquiries about AVERT Online can be directed to the principal investigator, Dr Julie Bernhardt at avert@nsri.org.au.
AVERT Online link: https://www.avertonline.org.au/login.php
National Stroke Research Institute
