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Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol

Background: The complex nature of stroke sequelae, the heterogeneity in rehabilitation pathways, and the lack of validated prediction models of rehabilitation outcomes challenge stroke rehabilitation quality assessment and clinical research. An integrated care pathway (ICP), defining a reproducible...

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Autores principales: Hakiki, Bahia, Paperini, Anita, Castagnoli, Chiara, Hochleitner, Ines, Verdesca, Sonia, Grippo, Antonello, Scarpino, Maenia, Maiorelli, Antonio, Mosca, Irene Eleonora, Gemignani, Paola, Borsotti, Marco, Gabrielli, Maria Assunta, Salvadori, Emilia, Poggesi, Anna, Lucidi, Giulia, Falsini, Catiuscia, Gentilini, Monica, Martini, Monica, Luisi, Maria Luisa Eliana, Biffi, Barbara, Mainardi, Paolo, Barretta, Teresa, Pancani, Silvia, Mannini, Andrea, Campagnini, Silvia, Bagnoli, Silvia, Ingannato, Assunta, Nacmias, Benedetta, Macchi, Claudio, Carrozza, Maria Chiara, Cecchi, Francesca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8060493/
https://www.ncbi.nlm.nih.gov/pubmed/33897593
http://dx.doi.org/10.3389/fneur.2021.632672
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author Hakiki, Bahia
Paperini, Anita
Castagnoli, Chiara
Hochleitner, Ines
Verdesca, Sonia
Grippo, Antonello
Scarpino, Maenia
Maiorelli, Antonio
Mosca, Irene Eleonora
Gemignani, Paola
Borsotti, Marco
Gabrielli, Maria Assunta
Salvadori, Emilia
Poggesi, Anna
Lucidi, Giulia
Falsini, Catiuscia
Gentilini, Monica
Martini, Monica
Luisi, Maria Luisa Eliana
Biffi, Barbara
Mainardi, Paolo
Barretta, Teresa
Pancani, Silvia
Mannini, Andrea
Campagnini, Silvia
Bagnoli, Silvia
Ingannato, Assunta
Nacmias, Benedetta
Macchi, Claudio
Carrozza, Maria Chiara
Cecchi, Francesca
author_facet Hakiki, Bahia
Paperini, Anita
Castagnoli, Chiara
Hochleitner, Ines
Verdesca, Sonia
Grippo, Antonello
Scarpino, Maenia
Maiorelli, Antonio
Mosca, Irene Eleonora
Gemignani, Paola
Borsotti, Marco
Gabrielli, Maria Assunta
Salvadori, Emilia
Poggesi, Anna
Lucidi, Giulia
Falsini, Catiuscia
Gentilini, Monica
Martini, Monica
Luisi, Maria Luisa Eliana
Biffi, Barbara
Mainardi, Paolo
Barretta, Teresa
Pancani, Silvia
Mannini, Andrea
Campagnini, Silvia
Bagnoli, Silvia
Ingannato, Assunta
Nacmias, Benedetta
Macchi, Claudio
Carrozza, Maria Chiara
Cecchi, Francesca
author_sort Hakiki, Bahia
collection PubMed
description Background: The complex nature of stroke sequelae, the heterogeneity in rehabilitation pathways, and the lack of validated prediction models of rehabilitation outcomes challenge stroke rehabilitation quality assessment and clinical research. An integrated care pathway (ICP), defining a reproducible rehabilitation assessment and process, may provide a structured frame within investigated outcomes and individual predictors of response to treatment, including neurophysiological and neurogenetic biomarkers. Predictors may differ for different interventions, suggesting clues to personalize and optimize rehabilitation. To date, a large representative Italian cohort study focusing on individual variability of response to an evidence-based ICP is lacking, and predictors of individual response to rehabilitation are largely unexplored. This paper describes a multicenter study protocol to prospectively investigate outcomes and predictors of response to an evidence-based ICP in a large Italian cohort of stroke survivors undergoing post-acute inpatient rehabilitation. Methods: All patients with diagnosis of ischemic or hemorrhagic stroke confirmed both by clinical and brain imaging evaluation, admitted to four intensive rehabilitation units (adopting the same stroke rehabilitation ICP) within 30 days from the acute event, aged 18+, and providing informed consent will be enrolled (expected sample: 270 patients). Measures will be taken at admission (T0), at discharge (T1), and at follow-up 6 months after a stroke (T2), including clinical data, nutritional, functional, neurological, and neuropsychological measures, electroencephalography and motor evoked potentials, and analysis of neurogenetic biomarkers. Statistics: In addition to classical multivariate logistic regression analysis, advanced machine learning algorithms will be cross-validated to achieve data-driven prognosis prediction models. Discussion: By identifying data-driven prognosis prediction models in stroke rehabilitation, this study might contribute to the development of patient-oriented therapy and to optimize rehabilitation outcomes. Clinical Trial Registration: ClinicalTrials.gov, NCT03968627. https://www.clinicaltrials.gov/ct2/show/NCT03968627?term=Cecchi&cond=Stroke&draw=2&rank=2.
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spelling pubmed-80604932021-04-23 Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol Hakiki, Bahia Paperini, Anita Castagnoli, Chiara Hochleitner, Ines Verdesca, Sonia Grippo, Antonello Scarpino, Maenia Maiorelli, Antonio Mosca, Irene Eleonora Gemignani, Paola Borsotti, Marco Gabrielli, Maria Assunta Salvadori, Emilia Poggesi, Anna Lucidi, Giulia Falsini, Catiuscia Gentilini, Monica Martini, Monica Luisi, Maria Luisa Eliana Biffi, Barbara Mainardi, Paolo Barretta, Teresa Pancani, Silvia Mannini, Andrea Campagnini, Silvia Bagnoli, Silvia Ingannato, Assunta Nacmias, Benedetta Macchi, Claudio Carrozza, Maria Chiara Cecchi, Francesca Front Neurol Neurology Background: The complex nature of stroke sequelae, the heterogeneity in rehabilitation pathways, and the lack of validated prediction models of rehabilitation outcomes challenge stroke rehabilitation quality assessment and clinical research. An integrated care pathway (ICP), defining a reproducible rehabilitation assessment and process, may provide a structured frame within investigated outcomes and individual predictors of response to treatment, including neurophysiological and neurogenetic biomarkers. Predictors may differ for different interventions, suggesting clues to personalize and optimize rehabilitation. To date, a large representative Italian cohort study focusing on individual variability of response to an evidence-based ICP is lacking, and predictors of individual response to rehabilitation are largely unexplored. This paper describes a multicenter study protocol to prospectively investigate outcomes and predictors of response to an evidence-based ICP in a large Italian cohort of stroke survivors undergoing post-acute inpatient rehabilitation. Methods: All patients with diagnosis of ischemic or hemorrhagic stroke confirmed both by clinical and brain imaging evaluation, admitted to four intensive rehabilitation units (adopting the same stroke rehabilitation ICP) within 30 days from the acute event, aged 18+, and providing informed consent will be enrolled (expected sample: 270 patients). Measures will be taken at admission (T0), at discharge (T1), and at follow-up 6 months after a stroke (T2), including clinical data, nutritional, functional, neurological, and neuropsychological measures, electroencephalography and motor evoked potentials, and analysis of neurogenetic biomarkers. Statistics: In addition to classical multivariate logistic regression analysis, advanced machine learning algorithms will be cross-validated to achieve data-driven prognosis prediction models. Discussion: By identifying data-driven prognosis prediction models in stroke rehabilitation, this study might contribute to the development of patient-oriented therapy and to optimize rehabilitation outcomes. Clinical Trial Registration: ClinicalTrials.gov, NCT03968627. https://www.clinicaltrials.gov/ct2/show/NCT03968627?term=Cecchi&cond=Stroke&draw=2&rank=2. Frontiers Media S.A. 2021-04-08 /pmc/articles/PMC8060493/ /pubmed/33897593 http://dx.doi.org/10.3389/fneur.2021.632672 Text en Copyright © 2021 Hakiki, Paperini, Castagnoli, Hochleitner, Verdesca, Grippo, Scarpino, Maiorelli, Mosca, Gemignani, Borsotti, Gabrielli, Salvadori, Poggesi, Lucidi, Falsini, Gentilini, Martini, Luisi, Biffi, Mainardi, Barretta, Pancani, Mannini, Campagnini, Bagnoli, Ingannato, Nacmias, Macchi, Carrozza and Cecchi. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Hakiki, Bahia
Paperini, Anita
Castagnoli, Chiara
Hochleitner, Ines
Verdesca, Sonia
Grippo, Antonello
Scarpino, Maenia
Maiorelli, Antonio
Mosca, Irene Eleonora
Gemignani, Paola
Borsotti, Marco
Gabrielli, Maria Assunta
Salvadori, Emilia
Poggesi, Anna
Lucidi, Giulia
Falsini, Catiuscia
Gentilini, Monica
Martini, Monica
Luisi, Maria Luisa Eliana
Biffi, Barbara
Mainardi, Paolo
Barretta, Teresa
Pancani, Silvia
Mannini, Andrea
Campagnini, Silvia
Bagnoli, Silvia
Ingannato, Assunta
Nacmias, Benedetta
Macchi, Claudio
Carrozza, Maria Chiara
Cecchi, Francesca
Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
title Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
title_full Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
title_fullStr Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
title_full_unstemmed Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
title_short Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
title_sort predictors of function, activity, and participation of stroke patients undergoing intensive rehabilitation: a multicenter prospective observational study protocol
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8060493/
https://www.ncbi.nlm.nih.gov/pubmed/33897593
http://dx.doi.org/10.3389/fneur.2021.632672
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