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Thoughts About the Negative Results of Clinical Trials in Rehabilitation Medicine

Carolee Winstein

The last decade has witnessed an increase in the number of moderate to large-scale nonpharmacologic stroke recovery trials. While a majority, having tested the superiority of a particular evidence-based intervention, returned negative findings, the rehabilitation research community has gained an important perspective for future efforts. We offer our interpretation first, on why most of the past decade’s trials failed in the sense of not supporting the primary superiority hypothesis, and, second, we provide our perspective on how to solve this problem and thereby inform the next generation of neurorehabilitation clinical trials. The first large-scale randomized controlled trial (RCT) ever conducted in neurorehabilitation was the Extremity Constraint Induced Movement Therapy Evaluation (EXCITE) trial. The majority of stroke recovery trials that followed were based on a prevailing, but as yet immature science of brain-behavior mechanisms for recovery and limited practical know-how about how to select the most meaningful outcomes. The research community had been seduced by a set of preclinical studies, ignited by the 1990’s revolution in neuroscience and an oversimplified premise that high doses of task-oriented training was the most important ingredient to foster recovery. Here, we highlight recent qualitative and quantitative evidence, both mechanistic and theory-driven, that integrates crucial social and personal factors to inform a more mature science better suited for the next generation of recovery-supportive rehabilitation clinical trials.

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The V ˙ O 2 max Legacy of Hill and Lupton (1923)—100 Years On

Grégoire P. Millet, Johannes Burtscher, Nicolas Bourdillon, Giorgio Manferdelli, Martin Burtscher, and Øyvind Sandbakk

increases maximal exercise capacity in chronic heart failure: the role of skeletal muscle convective and diffusive oxygen transport . J Am Coll Cardiol . 2011 ; 58 ( 13 ): 1353 – 1362 . doi:10.1016/j.jacc.2011.06.025 20. Grassi B , Porcelli S , Marzorati M . Translational medicine: exercise

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A Meta-Analysis of the Effects of Aerobic Exercise on the Basal Level of Endothelial Progenitor Cells in Middle-Aged and Older Adults

Xiaoke Chen, Xinzheng Sun, Di Gao, Dan Qiu, and Hui He

). Concise review: Endothelial progenitor cells in regenerative medicine: Applications and challenges . STEM CELLS Translational Medicine, 5 ( 4 ), 530 – 538 . https://doi.org/10.5966/sctm.2015-0227 10.5966/sctm.2015-0227 De Biase , C. , De Rosa , R. , Luciano , R. , De Luca , S. , Capuano , E

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Trait Perfectionism, Perfectionistic Self-Presentation, and Muscle Dysmorphia in Male Exercisers: A Structural Equation Modeling Strategy

Michael C. Grugan and Kieran J. Wright

there any associations? Journal of Translational Medicine, 12 ( 1 ), 1 – 8 . https://doi.org/10.1186/s12967-014-0221-2 Campagna , J.D. , & Bowsher , B. ( 2016 ). Prevalence of body dysmorphic disorder and muscle dysmorphia among entry-level military personnel . Military Medicine, 181 ( 5

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Electrical Stimulation of Distal Tibial Nerve During Stance Phase of Walking May Reverse Effects of Unilateral Paw Pad Anesthesia in the Cat

Hangue Park, Alexander N. Klishko, Kyunggeune Oh, Celina Zhang, Gina Grenga, Kinsey R. Herrin, John F. Dalton IV, Robert S. Kistenberg, Michel A. Lemay, Mark Pitkin, Stephen P. DeWeerth, and Boris I. Prilutsky

, J. , Di Pino , G. , . . . Micera , S. ( 2014 ). Restoring natural sensory feedback in real-time bidirectional hand prostheses . Science Translational Medicine, 6 ( 222 ), 222ra219 . https://doi.org/10.1126/scitranslmed.3006820 10.1126/scitranslmed.3006820 Schielzeth , H. , Dingemanse

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The Shared Criticisms of Periodization Models and Behavior-Change Theories for Exercise: An Opportunity for Collaborative Advancement?

Kelley Strohacker and Cory T. Beaumont

013e31821b94c8 Riley , W.T. , Glasgow , R.E. , Etheredge , L. , & Abernethy , A.P. ( 2013 ). Rapid, responsive, relevant (R3) research: A call for a rapid learning health research enterprise . Clinical and Translational Medicine, 2 ( 1 ), 10 . PubMed ID: 23663660 doi:10

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Engaging Multiple Medical Epistemologies: Medical Professionals’ Distance Running Advice and Treatment

Jennifer L. Walton-Fisette and Theresa A. Walton-Fisette

seeing medicine as science or art, she offers a “developing, untidy, methodological pluralism” (p. 225) that includes evidence-based medicine, consensus, translational medicine, and narrative medicine. Narrative medicine is one potential method that seeks to offer medical knowledge that accounts for

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Association Between Domain-Specific Physical Activity and Chronic Low Back Pain in Community-Dwelling Older Adults: A Cross-Sectional Study

Michael Douglas da Silva Martins, Ítalo Ribeiro Lemes, Eleonora Esposito, Priscila Kalil Morelhão, Pedro Henrique Narciso, Márcia Rodrigues Franco, and Rafael Zambelli Pinto

: Estimates from the Global Burden of Disease Study 2017 . Annals of Translational Medicine, 8 ( 6 ), 299 . https://doi.org/10.21037/atm.2020.02.175 32355743 Zanuto , E.A.C. , Fernandes , R.A. , Turi-Lynch , B.C. , Castoldi , R.C. , Morais , L.C. , Silva , P. , & Codogno , J.S. ( 2020

Open access

Nutrition for Travel: From Jet lag To Catering

Shona L. Halson, Louise M. Burke, and Jeni Pearce

vivo and in vitro . Science Translational Medicine, 7 ( 305 ), 305ra146 . PubMed ID: 26378246 doi:10.1126/scitranslmed.aac5125 10.1126/scitranslmed.aac5125 Castell , L.M. , Nieman , D.C. , Bermon , S. , & Peeling , P. ( 2019 ). Exercise-induced illness and inflammation: Can immunonutrition

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Dietary Practices Adopted by Track-and-Field Athletes: Gluten-Free, Low FODMAP, Vegetarian, and Fasting

Dana M. Lis, Daniel Kings, and D. Enette Larson-Meyer

Translational Medicine, 14 ( 1 ), 290 . PubMed ID: 27737674 doi:10.1186/s12967-016-1044-0 10.1186/s12967-016-1044-0 Morton , J. , Stellingwerff , T. , & Burke , L.M. ( 2018 ). Periodised nutrition for training adaptation . International Journal of Sport Nutrition and Exercise Metabolism . Manuscript