Author Identifier (ORCID)
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.
Keywords
Aphasia, motor control, rehabilitation, stroke
Document Type
Journal Article
Date of Publication
9-17-2025
Article Number
e001212
Volume
7
Issue
2
Publication Title
BMJ Neurology Open
Publisher
BMJ Publishing Group
School
School of Medical and Health Sciences
Funding Information
Medical Research Future Fund (MRF2007425) and University of Melbourne (NA). Hayward: National Health and Medical Research Council (2016420) and National Heart Foundation of Australia (106607). Brodtmann: National Heart Foundation of Australia (104748). The funders/sponsor were not involved in study design, conduct, report writing or decision to submit this report for publication. The funder/sponsor did not influence the results/outcomes of this study despite author affiliations with the funder/sponsor.
Funding received from the National Health and Medical Research Council (NHMRC)
2016420
Funding received from the Medical Research Future Fund (MRFF)
2007425
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Recommended Citation
Hayward, K. S., Donnan, G., Godecke, E., Balabanski, A., Barker, R., Bernhardt, J., Brauer, S., Brodtmann, A., Brogan, E., Brownsett, S., Chapman, P., Copland, D., Cowley, E., Dalton, E., Ellery, F., Fink, P., Garcia Esperon, C., Hill, A. J., Janssen, H., & Kavanagh, S. (2025). Integrated UPper limb and Language Impairment and Functional Training (UPLIFT) after stroke: Study protocol for an umbrella Bayesian Optimal Phase IIa clinical trial. BMJ Neurology Open, 7, Article e001212. https://doi.org/10.1136/bmjno-2025-001212
Comments
Hayward, K. S., Donnan, G., Godecke, E., Balabanski, A., Barker, R., Bernhardt, J., Brauer, S., Brodtmann, A., Brogan, E., Brownsett, S., Chapman, P., Copland, D., Cowley, E., Dalton, E., Ellery, F., Fink, P., Garcia Esperon, C., Hill, A. J., Janssen, H., & Kavanagh, S. (2025). Integrated UPper limb and Language Impairment and Functional Training (UPLIFT) after stroke: Study protocol for an umbrella Bayesian Optimal Phase IIa clinical trial. BMJ Neurology Open, 7, e001212. https://doi.org/10.1136/bmjno-2025-001212