NeurologyLive spoke with Julie Bernhardt, PhD, to learn more about her investigations into developing guidelines for very early mobilization for stroke treatment.
Julie Bernhardt, PhD
A recent tertiary analysis of the prospective, parallel-group, randomized clinical trial, AVERT (A Very Early Rehabilitation Trial) showed that the high-dose, intensive training of very early mobilization (VEM) increased mortality in patients within 14 days post-stroke when compared to usual care (UC).
Previously, study author Julie Bernhardt, PhD, laboratory head, Avert Early Rehabilitation Research Group, and director, NHMRC Centre of Research Excellence in Stroke Rehabilitation and Recovery, and colleagues found no significant differences between VEM and UC deaths observed within 3 months. Bernhardt and colleagues then restricted follow-up to 14 days post-stroke for this analysis, identifying significant differences between groups. Following these results, clinical guidelines have been revised to reflect their findings and recommendations to delay or modify mobilization practices now exist.
Bernhardt and colleagues found that the use of VEM may have negative associations with higher age and intracerebral hemorrhages that require further study to understand who is most at risk with early activity to achieve the development of safe protocols for acute stroke patients. NeurologyLive spoke to Bernhardt to learn more about her investigations into finding safe guidelines for VEM.
NeurologyLive has previously written about the team's findings. Read more about Bernhardt’s paper by clicking here.
Julie Bernhardt, PhD: We’ve used the information from this paper as well as previous analyses published in Neurology (2016) and additional work to develop refined protocols for testing in a new trial called AVERT DOSE, the final trial in this series that aims to identify the optimal safe and effective early mobility training protocols for people with mild and moderate ischemic stroke. This trial in funded by the NHMRC and is running in 7 countries (Australia, UK, Ireland, Malaysia, India, Brazil, New Zealand) – In the final adaptive dose-response trial we are testing 4 doses of intervention starting within 48 hours of stroke (so later), across mild and moderate stroke patients and will keep the most promising interventions in the final analysis.
We are not including people with very severe stroke (NIHSS >16—who you will see are well represented in this current analysis) nor are including people with Intracerebral hemorrhage—again due to safety concerns and because these individuals are likely to need more nuanced and less protocolized management.
The takeaways here are—deaths are low in the trial overall—early deaths are low, but you can cause harm by doing too much too soon and we need to determine safe and effective protocols for people in this early phase of stroke care.
Transcript edited for clarity.