Presenter of 3 Presentations
PROTOCOL FOR A PHASE IIA MULTICENTRE UMBRELLA TRIAL OF INTEGRATED UPPER LIMB AND LANGUAGE IMPAIRMENT AND FUNCTIONAL TRAINING (UPLIFT) IN PEOPLE 3-24 MONTHS POST STROKE.
Dosage, Content and Timing of Rehabilitation After Stroke
PROTOCOL FOR A PHASE IIA MULTICENTRE UMBRELLA TRIAL OF INTEGRATED UPPER LIMB AND LANGUAGE IMPAIRMENT AND FUNCTIONAL TRAINING (UPLIFT) IN PEOPLE 3-24 MONTHS POST STROKE.
Abstract
Background and Aims
One in six stroke survivors experience loss of arm and communication functions at 3 months post-stroke. The aim of this study is to identify promising model(s) of integrated UPper limb and Language Impairment and Functional Training (UPLIFT) for people 3 to 24 months after stroke. It is hypothesised that at least one promising UPLIFT model of rehabilitation will be identified.
Methods
This is a Phase IIa umbrella design that includes four simultaneous Bayesian Optimal Phase II (BOP) trials to evaluate individual UPLIFT interventions. The UPLIFT intervention is intensive daily upper limb and language training (2 or 4 hours/day for 4 weeks duration), delivered either in-person or via telerehabilitation depending on severity stratum. Up to 160 adult participants will be recruited across urban and regional hubs around Australia. All participants will undergo blinded baseline and post-intervention assessment. For each UPLIFT intervention, the rate of promising response (composite efficacy, safety, and feasibility outcome) will be monitored at equally spaced, predefined stopping points. Too few promising responses will mean an individual UPLIFT intervention is stopped and future trial participants are directed into other UPLIFT intervention under investigation. Registration: ACTRN12622000373774.
Results
UPLIFT is an ongoing clinical trial. The trial protocol will be presented.
Conclusions
As the first umbrella trial in stroke recovery, we will test and promote a more efficient trial process than previously undertaken. This will efficiently and rigorously evaluate our model of rehabilitation, and identify integrated UPLIFT intervention(s) with promise to take forward to a seamless Phase IIb-III trial.