Integrated UPper limb and Language Impairment and Functional Training (UPLIFT) after stroke: study protocol for an...

Area of Science:

• Neurorehabilitation
• Stroke Recovery
• Clinical Trials

Background:

• Stroke frequently causes persistent upper limb and language impairments.
• A significant portion of stroke survivors experience long-term disability.
• Effective rehabilitation strategies are crucial for functional recovery.

Purpose of the Study:

• To identify promising models of integrated Upper Limb and Language Impairment and Functional Training (UPLIFT) for stroke survivors.
• To evaluate the efficacy, safety, and feasibility of UPLIFT interventions.
• To determine optimal rehabilitation approaches for individuals 3-24 months post-stroke.

Main Methods:

• Adaptive Phase IIa master protocol with four simultaneous Bayesian Optimal Phase II studies.
• Interventions include 2-4 hours/day, 5 days/week, 4-week training (in-person or telerehabilitation).
• Up to 160 participants recruited across six Australian hubs; blinded assessments.

Main Results:

• The study is designed to monitor for promising responses at interim and final analysis points.
• Interventions will be stopped if insufficient promising responses are observed.
• A composite binary outcome defines a promising response, assessing efficacy, safety, and feasibility.

Conclusions:

• This research seeks to advance neurorehabilitation by identifying effective UPLIFT models.
• Findings will inform future stroke recovery protocols and interventions.
• The study aims to provide evidence-based rehabilitation options for upper limb and language deficits.