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

被引：32

作者：

Bernhardt, Julie ^{[1
]}

Hayward, Kathryn S. ^{[1
]}

Dancause, Numa ^{[2
]}

Lannin, Natasha A. ^{[3
,4
]}

Ward, Nick S. ^{[5
]}

Nudo, Randolph J. ^{[6
]}

Farrin, Amanda ^{[7
]}

Churilov, Leonid ^{[8
]}

Boyd, Lara A. ^{[9
,10
]}

Jones, Theresa A. ^{[11
,12
]}

Carmichael, S. Thomas ^{[13
]}

Corbett, Dale ^{[14
,15
]}

Cramer, Steven C. ^{[13
,16
]}

机构：

[1] Univ Melbourne, Florey Inst Neurosci & Mental Hlth, Stroke Theme & NHRMC CRE Stroke Rehabil & Brain R, Melbourne, Vic, Australia

[2] Univ Montreal, Dept Neurosci, Montreal, PQ, Canada

[3] Monash Univ, Cent Clin Sch, Dept Clin Neurosci, Melbourne, Vic, Australia

[4] Alfred Hlth, Melbourne, Vic, Australia

[5] UCL Queen Sq Inst Neurol, Dept Clin & Motor Neurosci, London, England

[6] Univ Kansas, Med Ctr, Dept Rehabil Med, Kansas City, KS 66103 USA

[7] Univ Leeds, Leeds Inst Clin Trial Res, Leeds, W Yorkshire, England

[8] Univ Melbourne, Melbourne Med Sch, Melbourne, Vic, Australia

[9] Univ British Columbia, Dept Phys Therapy, Vancouver, BC, Canada

[10] Univ British Columbia, Ctr Brain Hlth, Vancouver, BC, Canada

[11] Univ Texas Austin, Dept Psychol, Austin, TX 78712 USA

[12] Univ Texas Austin, Inst Neurosci, Austin, TX 78712 USA

[13] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA 90095 USA

[14] Univ Ottawa, Cellular & Mol Med, Ottawa, ON, Canada

[15] Univ Ottawa, Canadian Partnership Stroke Recovery, Ottawa, ON, Canada

[16] Calif Rehabil Inst, Los Angeles, CA USA

来源：

NEUROREHABILITATION AND NEURAL REPAIR | 2019年 / 33卷 / 11期

基金：

澳大利亚国家健康与医学研究理事会; 加拿大健康研究院;

关键词：

Stroke; rehabilitation; recovery; consensus; trial design; GO NO-GO; ALGORITHM; STANDARDS;

D O I：

10.1177/1545968319888642

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：959 / 969

页数：11

共 37 条

[1] Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce [J].

Bernhardt, Julie ;

Hayward, Kathryn S. ;

Kwakkel, Gert ;

Ward, Nick S. ;

Wolf, Steven L. ;

Borschmann, Karen ;

Krakauer, John W. ;

Boyd, Lara A. ;

Carmichael, S. Thomas ;

Corbett, Dale ;

Cramer, Steven C. .

INTERNATIONAL JOURNAL OF STROKE, 2017, 12 (05) :444-450

[2] Adaptive Designs for Clinical Trials [J].

Bhatt, Deepak L. ;

Mehta, Cyrus .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (01) :65-74

[3] Efficacy of rehabilitative experience declines with time after focal ischemic brain injury [J].

Biernaskie, J ;

Chernenko, G ;

Corbett, D .

JOURNAL OF NEUROSCIENCE, 2004, 24 (05) :1245-1254

[4] Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review [J].

Borschmann, Karen ;

Hayward, Kathryn S. ;

Raffelt, Audrey ;

Churilov, Leonid ;

Kramer, Sharon ;

Bernhardt, Julie .

STROKE RESEARCH AND TREATMENT, 2018, 2018

[5] Biomarkers of stroke recovery: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable [J].

Boyd, Lara A. ;

Hayward, Kathryn S. ;

Ward, Nick S. ;

Stinear, Cathy M. ;

Rosso, Charlotte ;

Fisher, Rebecca J. ;

Carter, Alexandre R. ;

Leff, Alex P. ;

Copland, David A. ;

Carey, Leeanne M. ;

Cohen, Leonardo G. ;

Basso, D. Michele ;

Maguire, Jane M. ;

Cramer, Steven C. .

INTERNATIONAL JOURNAL OF STROKE, 2017, 12 (05) :480-493

[6] A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis [J].

Bratton, Daniel J. ;

Phillips, Patrick P. J. ;

Parmar, Mahesh K. B. .

BMC MEDICAL RESEARCH METHODOLOGY, 2013, 13

[7] A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development [J].

Colucci, E. ;

Clark, A. ;

Lang, C. E. ;

Pomeroy, V. M. .

PHYSIOTHERAPY, 2017, 103 (04) :414-422

[8] Enhancing the alignment of the preclinical and clinical stroke recovery research pipeline: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable translational working group [J].

Corbett, Dale ;

Carmichael, S. Thomas ;

Murphy, Timothy H. ;

Jones, Theresa A. ;

Schwab, Martin E. ;

Jolkkonen, Jukka ;

Clarkson, Andrew N. ;

Dancause, Numa ;

Weiloch, Tadeusz ;

Johansen-Berg, Heidi ;

Nilsson, Michael ;

McCullough, Louise D. ;

Joy, Mary T. .

INTERNATIONAL JOURNAL OF STROKE, 2017, 12 (05) :462-471

[9]

Council MR, 2006, DEV EVALUATING COMPL

[10] Long-Dose Intensive Therapy Is Necessary for Strong, Clinically Significant, Upper Limb Functional Gains and Retained Gains in Severe/Moderate Chronic Stroke [J].

Daly, Janis J. ;

McCabe, Jessica P. ;

Holcomb, John ;

Monkiewicz, Michelle ;

Gansen, Jennifer ;

Pundik, Svetlana .

NEUROREHABILITATION AND NEURAL REPAIR, 2019, 33 (07) :523-537

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