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

Julie Bernhardt; Kathryn S Hayward; Numa Dancause; Natasha A Lannin; Nick S Ward; Randolph J Nudo; Amanda Farrin; Leonid Churilov; Lara A Boyd; Theresa A Jones; S Thomas Carmichael; Dale Corbett; Steven C Cramer

doi:10.1177/1747493019879657

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

Int J Stroke. 2019 Oct;14(8):792-802. doi: 10.1177/1747493019879657.

Authors

Affiliations

¹ Stroke Theme and NHRMC CRE in Stroke Rehabilitation and Brain Recovery, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia.
² Département de Neurosciences, Université de Montréal, Montréal, Québec, Canada.
³ Department of Clinical Neuroscience, Central Clinical School, Monash University; Alfred Health, Melbourne, Australia.
⁴ Department of Clinical and Motor Neuroscience, UCL Queen Square Institute of Neurology, London, UK.
⁵ Department of Rehabilitation Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
⁶ Leeds Institute of Clinical Trial Research, University of Leeds, Leeds, UK.
⁷ Melbourne Medical School, University of Melbourne, Melbourne, Australia.
⁸ Department of Physical Therapy & Centre for Brain Health, University of British Columbia, Vancouver, Canada.
⁹ Psychology Department and Institute for Neuroscience, University of Texas at Austin, Austin, TX, USA.
¹⁰ Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
¹¹ Cellular & Molecular Medicine and Canadian Partnership for Stroke Recovery, University of Ottawa, Ottawa, Canada.
¹² Department of Neurology, David Geffen School of Medicine at UCLA; California Rehabilitation Institute, Los Angeles, CA, USA.

PMID: 31658893
DOI: 10.1177/1747493019879657

Abstract

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.

Keywords: GO NO-GO; Stroke; consensus; recovery; rehabilitation; trial design.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Clinical Trials as Topic
Congresses as Topic
Consensus*
Decision Making
Humans
International Cooperation
Motivation
Movement
Patient Selection
Physical Functional Performance
Recovery of Function
Rehabilitation Research / trends
Stroke / therapy*
Stroke Rehabilitation / methods*
Stroke Rehabilitation / trends
Upper Extremity / physiology

Grants and funding

CIHR/Canada