Frontiers in Neurology (Jan 2021)

Rehabilitation and Biomarkers of Stroke Recovery: Study Protocol for a Randomized Controlled Trial

  • Alessandro Picelli,
  • Mirko Filippetti,
  • Lidia Del Piccolo,
  • Federico Schena,
  • Leonardo Chelazzi,
  • Chiara Della Libera,
  • Massimo Donadelli,
  • Valeria Donisi,
  • Paolo Francesco Fabene,
  • Stefania Fochi,
  • Cristina Fonte,
  • Marialuisa Gandolfi,
  • Macarena Gomez-Lira,
  • Elena Locatelli,
  • Giovanni Malerba,
  • Sofia Mariotto,
  • Chiara Milanese,
  • Cristina Patuzzo,
  • Maria Grazia Romanelli,
  • Andrea Sbarbati,
  • Stefano Tamburin,
  • Massimo Venturelli,
  • Paola Zamparo,
  • Alessandra Carcereri de Prati,
  • Elena Butturini,
  • Valentina Varalta,
  • Nicola Smania

DOI
https://doi.org/10.3389/fneur.2020.618200
Journal volume & issue
Vol. 11

Abstract

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Background: Stroke is a leading cause of disability. Nonetheless, the care pathway for stroke rehabilitation takes partially into account the needs of chronic patients. This is due in part to the lack of evidence about the mechanisms of recovery after stroke, together with the poor knowledge of related and influencing factors. Here we report on the study protocol “Rehabilitation and Biomarkers of Stroke Recovery,” which consists of 7 work-packages and mainly aim to investigate the effects of long-term neurorehabilitation on stroke patients and to define a related profile of (clinical-biological, imaging, neurophysiological, and genetic-molecular) biomarkers of long-term recovery after stroke. The work-package 1 will represent the main part of this protocol and aims to compare the long-term effects of intensive self-rehabilitation vs. usual (rehabilitation) care for stroke.Methods: We planned to include a total of 134 adult subacute stroke patients (no more than 3 months since onset) suffering from multidomain disability as a consequence of first-ever unilateral ischemic stroke. Eligible participants will be randomly assigned to one of the following groups: intensive self-rehabilitation (based on the principles of “Guided Self-Rehabilitation Contract”) vs. usual care (routine practice). Treatment will last 1 year, and patients will be evaluated every 3 months according to their clinical presentation. The following outcomes will be considered in the main work-package: Fugl-Meyer assessment, Cognitive Oxford Screen Barthel Index, structural and functional neuroimaging, cortical excitability, and motor and somatosensory evoked potentials.Discussion: This trial will deal with the effects of an intensive self-management rehabilitation protocol and a related set of biomarkers. It will also investigate the role of training intensity on long-term recovery after stroke. In addition, it will define a set of biomarkers related to post-stroke recovery and neurorehabilitation outcome in order to detect patients with greater potential and define long-term individualized rehabilitation programs.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT04323501.

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