Oral Presentation Smart Strokes Annual Scientific Meeting 2024

Involvement in a large International Acute Stroke Rehabilitation Clinical Trial (AVERT DOSE) - A local post COVID perspective. (106915)

Natasha Gillman 1 , Kelly Jones 2 , Kirsty Page 1 , Lauren J Christie 1 , Nicole Matheson 1 , Sandy Middleton 2 , Fiona L Ellery 3 , Julie Bernhardt 3
  1. St Vincent's Hospital Sydney, Darlinghurst, NSW, Aus
  2. Australian Catholic University, North Sydney, NSW, Australia
  3. The Florey Institute of Neuroscience and Mental Health, Heidleberg, VIC, Australia

Introduction:

AVERT DOSE is the first trial to use an adaptive trial design in acute stroke rehabilitation to define optimal early onset mobility training regimens for patients with mild and moderate ischemic stroke.

Methods:

This is an ongoing international Multi-Arm, Multi-Stage, Covariate-Adjusted, Response-Adaptive randomised trial. Patients in mild (NIHSS 0-7) and moderate (NIHSS 8-16) stroke severity strata are randomised to one of four mobility training regimens (including a pre-specified reference group), provided by stroke unit physiotherapists and nurses, starting within 48 hours of stroke and provided for up to 14 days. Inclusion criteria: Ischaemic stroke within 48 hours, ≥18 years. Exclusion criteria: Severe stroke (NIHSS>16), medically unwell, no evident mobility problems. Primary Outcome: Blinded Assessment of proportion of participants achieving a favourable outcome (mRS score 0-2) at 3 months post stroke. An adaptive sample size re-estimation provides 80% power to detect a 10% absolute treatment effect or larger compared to the pre-specified reference group. Analyses will be intention-to-treat.

Results:

Hospitals in Australia, Singapore, Malaysia, India, UK, Ireland and Brazil are actively recruiting with 671 participants to date. Overall trial recruitment is slower than expected despite resumption of relatively normal hospital services post COVID.  Main reasons for non-inclusion: presentation to hospital >48 hours (26.1%), participant presenting with no mobility issues (25.3%), pre-stroke mRS of 3, 4 or 5 (9.5%), discharge within 3 days of admission to stroke unit (9.4%).

Conclusion:

Recruitment to AVERT DOSE is challenging in Australia post COVID and service delivery changes over time have had an impact on the ability to recruit. 

 

Relevance to clinical practice

This last trial in the AVERT series will provide important new information about the dose and timing of early rehabilitation after ischaemic stroke. International collaborative efforts will ensure that results of the trial will be globally generalisable.