A stroke recovery trial development framework: Consensus-based core recommendations from the Second Stroke Recovery...

Area of Science:

• Neuroscience
• Clinical Trials
• Rehabilitation Medicine

Background:

• Stroke recovery is often limited, necessitating novel treatment development.
• Current treatment trials face challenges in design and decision-making.
• The Stroke Recovery and Rehabilitation Roundtable (SRRR) seeks to advance post-stroke recovery.

Purpose of the Study:

• To outline critical considerations for next-generation stroke recovery treatment trials.
• To introduce the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF).
• To demonstrate the SRRR-TDF's utility in guiding trial development decisions.

Main Methods:

• Literature review and expert consensus within the SRRR.
• Development of a structured framework for trial evaluation.
• Application of the framework to an upper limb stroke recovery trial exemplar.

Main Results:

• Key issues for future stroke recovery trials are identified.
• The SRRR-TDF provides a systematic approach to trial development.
• The exemplar trial demonstrates the framework's effectiveness in GO/NO-GO decisions.

Conclusions:

• The SRRR-TDF can accelerate the development of effective stroke recovery interventions.
• Implementing this framework can optimize resource allocation for clinical trials.
• This approach supports evidence-based decision-making in stroke rehabilitation research.