A Stroke Recovery Trial Development Framework: Consensus-Based Core Recommendations from the Second Stroke Recovery and Rehabilitation Roundtable,Neurorehabilitation and Neural Repair

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A Stroke Recovery Trial Development Framework: Consensus-Based Core Recommendations from the Second Stroke Recovery and Rehabilitation Roundtable
Neurorehabilitation and Neural Repair ( IF 3.7 ) Pub Date : 2019-11-01 , DOI: 10.1177/1545968319888642
Julie Bernhardt ₁ , Kathryn S Hayward ₁ , Numa Dancause ₂ , Natasha A Lannin ₃ , Nick S Ward ₄ , Randolph J Nudo ₅ , Amanda Farrin ₆ , Leonid Churilov ₇ , Lara A Boyd ₈ , Theresa A Jones ₉ , S Thomas Carmichael ₁₀ , Dale Corbett ₁₁ , Steven C Cramer ₁₂

Affiliation

Stroke Theme and NHRMC CRE in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.
Departement de Neurosciences, Université de Montréal, Montréal, Québec, Canada.
Department of Clinical Neuroscience, Central Clinical School, Monash University; Alfred Health, Melbourne, Australia.
Department of Clinical and Motor Neuroscience, UCL Queen Square Institute of Neurology, London, UK.
Department of Rehabilitation Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
Leeds Institute of Clinical Trial Research, University of Leeds, Leeds, UK.
Melbourne Medical School, University of Melbourne, Melbourne, Australia.
Department of Physical Therapy & Centre for Brain Health, University of British Columbia, Vancouver, Canada.
Psychology Department and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.
Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Cellular & Molecular Medicine and Canadian Partnership for Stroke Recovery, University of Ottawa, Ottawa, Canada.
Department of Neurology, David Geffen School of Medicine at UCLA; California Rehabilitation Institute, Los Angeles, CA, USA.

A major goal of the Stroke Recovery and Rehabilitation Roundtable (SRRR) is to accelerate development of effective treatments to enhance stroke recovery beyond that expected to occur spontaneously or with current approaches. In this paper, we describe key issues for the next generation of stroke recovery treatment trials and present the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF). An exemplar (an upper limb recovery trial) is presented to demonstrate the utility of this framework to guide the GO, NO-GO decision-making process in trial development.

中文翻译：

中风康复试验开发框架：来自第二次中风康复和康复圆桌会议的基于共识的核心建议

中风恢复和康复圆桌会议 (SRRR) 的一个主要目标是加快有效治疗方法的开发，以提高中风恢复的能力，使其超出预期的自发性或现有方法。在本文中，我们描述了下一代卒中恢复治疗试验的关键问题，并提出了卒中恢复和康复圆桌试验开发框架 (SRRR-TDF)。提供了一个示例（上肢恢复试验）以证明该框架在试验开发中指导 GO、NO-GO 决策过程的效用。

更新日期：2019-11-01

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