World’s largest study of stroke rehabilitation to change clinical practice guidelines

Professor Thrift

Monash University researchers have contributed to the largest-ever study to work out the most effective rehabilitation treatment for stroke patients.

Published in The Lancet this month, the multicentre randomised controlled AVERT trial reveals the effects of very early patient mobilisation following a stroke, with results that surprised the study authors.

Early patient mobilisation, comprising out-of-bed sitting, standing and walking after a stroke is currently recommended in many patient care guidelines and adopted in most stroke units.  Such mobilisation contributes to the positive effects of stroke-unit care, where patients receive organised care from a variety of clinicians including doctors, therapists and nurses.

To date there have been only a few small studies providing preliminary evidence of the benefit of early patient mobilisation. Importantly, it was unknown whether mobilising stroke patients more frequently than usual in the very early phase (within the first 24 hours) was beneficial and safe.

“To overcome the previous lack of evidence we conducted a large, multicentre randomised trial to determine the safety and efficacy of very early and frequent mobilisation,” said one of the main investigators, Professor Amanda Thrift, Head of Epidemiology and Prevention, Stroke and Ageing Research Group at the School of Clinical Sciences.

“We based this on our previous pilot study which seemed to indicate an early, frequent, higher dose very early mobilisation (VEM) protocol may increase the odds of a favourable outcome compared with usual stroke unit care.”

Of significance, the AVERT study represents the largest acute stroke rehabilitation trial ever done with a complex intervention directed by existing physiotherapy and nursing staff.

Conducted in 56 centres across five countries, 2104 patients were randomised over a period of eight years.  Adults with stroke were randomised to receive either usual stroke unit care or VEM in addition to usual care.

Intriguingly, and somewhat unexpectedly, the investigators found that 27 per cent fewer patients in the VEM group had a better outcome compared with those in the usual care group.

“However, when we compared VEM with usual care, there were no statistical differences in deaths and non-fatal serious events between the two groups,” said Head of the Stroke & Ageing Research Group at the School of Clinical Sciences, Associate Professor Velandai Srikanth, who was part of the team that determined whether or not these events were related to immobility.

“Fewer than 6 per cent of patients had any immobility related complications,” added Professor Srikanth. “This very low proportion of immobility-related complications was also unexpected but attests to the high quality of care.”

“Most patients, including those in the usual care group, were mobilised within 24 hour of stroke,” said Professor Thrift. “Interestingly, time to first mobilisation in the usual care group reduced by 28 minutes per year over the 8 years of the study indicating that early mobilisation was being adopted more routinely in recent times.”

In their review of 30 guidelines, the study authors noted early mobilisation was recommended in 22 examples, but with little, or more often, no information about the protocol that should be used.

“Despite the fact that early mobilisation is recommended in many clinical practice guidelines worldwide, our findings indicate that there should be some changes to these guidelines particularly in advising on the timing, intensity and frequency of mobilisation in the very early phase after stroke,” said Professor Thrift. 

“The obvious implication of our results is that start of a high-dose, frequent mobilisation protocol within 24 hours of stroke onset is not better than usual care at a centre that delivers high quality stroke unit care.”

It is possible that this higher dose therapy may be better than usual care in a centre that provides lesser quality care.  However, further analysis is being undertaken to advise on optimal timing, dose and frequency of therapy sessions and out-of-bed activity to improve patient outcomes.