Integrated UPper limb and Language Impairment and Functional Training (UPLIFT) after stroke: study protocol for an umbrella Bayesian Optimal Phase IIa clinical trial.
Kathryn S Hayward, Geoffrey Donnan, Erin Godecke, Anna Balabanski, Ruth Barker, Julie Bernhardt, Sandra Brauer, Amy Brodtmann, Emily Brogan, Sonia Brownsett, Paul Chapman, David Copland, Elise Cowley, Emily Dalton, Fiona Ellery, Paul Fink, Carlos Garcia Esperon, Annie J Hill, Heidi Janssen, Siobhan Kavanagh, Timothy Kleinig, Liudmyla Olenko, Joanne Je Quek, Trevor Russell, Moira Smith, Lillian Taylor, Vincent Thijs, Claire Tucak, John Turner, Declan Wode, Andrew Wong, Bronwyn Williams, Bruce C V Campbell, Leonid Churilov
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Abstract
Introduction: One in six stroke survivors continue to experience arm and language disability at 3 months post-stroke. This study aims to identify which model(s) of integrated UPper limb and Language Impairment and Functional Training (UPLIFT) show promise for people 3 months to 24 months post-stroke. We hypothesise that at least one promising UPLIFT model of rehabilitation will be identified.
Methods and analysis: This is an adaptive Phase IIa master protocol umbrella design that includes four simultaneous Bayesian Optimal Phase II studies to evaluate individual UPLIFT interventions against prespecified objective performance criteria. The intervention is upper limb and language training at 2 or 4 hours/day, 5 days/week for 4 weeks, delivered either in person (severe stratum) or via telerehabilitation (mild-moderate stratum). Up to 160 adult participants will be recruited across six metropolitan/regional university or healthcare hubs spanning five Australian states. Baseline and post-intervention assessments are blinded. A promising response is defined as a composite binary outcome combining indicators of promise of efficacy, safety and feasibility. For each UPLIFT intervention, the proportion of participants with a promising response will be monitored at three equally spaced, predefined interim stopping points and one final analysis point (n=40 participants/study). An intervention will be stopped if too few promising responses are observed.
Ethics and dissemination: Ethical approval was obtained from The Royal Melbourne Human Research Ethics Committee. All participating sites obtained local governance approval. All recruited participants will provide informed consent. Trial results will be disseminated through peer-reviewed publications and presented at major stroke and rehabilitation conferences.
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