Our proposal will establish a novel and innovative adaptive sequential multiple assignment (SMART) randomised trial (FASTRACK-UL) to test multiple treatments to address the urgent unmet need for improved stroke recovery treatments. This unmet need is driven by our current evidence-base and is manifested by the significant burden that arises from stroke-related disability. Past trials have failed to address the reality that not all individuals will respond to upper limb treatments to the same degree, or within the same time frame, or within the same sequence of treatment/s. Rather than delivering a single, fixed treatment to all stroke survivors in the same way, our FASTRACK-UL trial will individualise a patient’s treatment based on how much improvement they achieve.
By testing the three most effective treatments for adults with moderate-severe stroke in FASTRACK-UL we will develop an optimised pathway for effective treatment for adults with moderate-severe stroke. But our innovative trial design has never before been used with stroke survivors in Australia and their acceptance of re-randomisation has never been tested. Therefore, our FASTRACK-UL pilot trial aims to (AIM 1) determine the feasibility of the SMART trial design by assessing (a) participant recruitment and (b) clinician adherence to treatment allocation decisions, and (AIM 2) its acceptability by evaluating (a) participant acceptance to dual-randomisation, (b) treatment dropout, (c) participants’ satisfaction, and (c) clinicians’ satisfaction. Importantly our proposal will also (AIM 3) determine the utility of recommended recovery biomarkers that may be used to tailor the motor training treatment. By testing the three most effective treatments currently available using this novel adaptive design, FASTRACK-UL will identify a treatment pathway tailored specifically to the needs of stroke survivors with very limited movement. Importantly, the FASTRACK-UL team are well positioned to not only complete this pilot but to leverage the findings into a definitive trial and build research capability to apply this innovative SMART trial design in stroke and beyond.
Last updated14 October 2025