ABSTRACT
Introduction: Mobility training is a complex intervention and recovery post-stroke is multidimensional. AVERT DOSE is the first trial to use an adaptive trial design in stroke rehabilitation and aims to define optimal early intervention regimens for people with mild to moderate ischaemic stroke. Seven Irish sites are participating. Method(s): AVERT DOSE (ACTRN:12619000557134) is a randomised trial that will recruit >2,500 patients internationally. Randomisation is to two groups according to stroke severity. Patients are then randomised to one of four mobility training regimens in each strata and the intervention is delivered for up to 14-days. Primary Outcome: Identification of the intervention regimen that results in higher proportion of favourable outcome at 3-months post-stroke. Seven Irish sites are participating. Result(s): In Ireland, 3 sites are recruiting (SJH, OLOLH, and MMUH) with 4 finalising contracts. Thirteen patients have been recruited to date in Ireland and 265 internationally. Trial set-up has proven complex and variable across Irish sites, with time to ethics approval ranging from 10-37-months. Given the COVID-19 pandemic and international nature of the trial, online training and meetings were necessitated for all Irish sites. Close communication, teamwork and shared responsibilities have supported this process. Flexibility was required with some blinded followup assessments using telehealth. Conclusion(s): Undertaking rehabilitation research requires a dynamic, problem-solving approach, particularly during a pandemic. Irish sites have embraced this opportunity to answer an important stroke research question. In Ireland, shared learning in trial governance should improve future rehabilitation trial readiness. Trial recruitment is expected to gain pace as more Irish and international sites are approved.