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

ABSTRACT: 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.

SUBMITTER: Hakiki B

PROVIDER: S-EPMC8060493 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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

Hakiki Bahia B Paperini Anita A Castagnoli Chiara C Hochleitner Ines I Verdesca Sonia S Grippo Antonello A Scarpino Maenia M Maiorelli Antonio A Mosca Irene Eleonora IE Gemignani Paola P Borsotti Marco M Gabrielli Maria Assunta MA Salvadori Emilia E Poggesi Anna A Lucidi Giulia G Falsini Catiuscia C Gentilini Monica M Martini Monica M Luisi Maria Luisa Eliana MLE Biffi Barbara B Mainardi Paolo P Barretta Teresa T Pancani Silvia S Mannini Andrea A Campagnini Silvia S Bagnoli Silvia S Ingannato Assunta A Nacmias Benedetta B Macchi Claudio C Carrozza Maria Chiara MC Cecchi Francesca F

Frontiers in neurology 20210408

<b>Background:</b> 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 neurogene ...[more]

PMID: 33897593

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Project description:IntroductionStroke and its long-term consequences pose major challenges for the lives of those affected and healthcare systems. Neurological rehabilitation therefore primarily attempts to improve function in order to increase independence in activities of daily living, and to enable social participation. There is only scarce data on dynamics of functional recovery after patients discharge from inpatient neurological rehabilitation. Even less is known about the patient's perspective on long-term recovery from stroke. The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE) aims to address this knowledge gap by providing new insights into the dynamics and extent of functional recovery from stroke beyond inpatient rehabilitation treatment.MethodsWe provide the protocol for an observational, longitudinal, multicenter study conducted in an Universitary Stroke Center in cooperation with five Neurological Rehabilitation Centers in Northern Germany. Patients who suffered from ischemic or hemorrhagic stroke will be enrolled by the end of inpatient rehabilitation and followed up to 1 year. In addition, a group of chronic stroke patients and a group of craniocerebral trauma patients will be enrolled as a comparison group. Data on stroke characteristics, vascular risk factors, co-morbidities, social support, and demographics will be recorded. Comprehensive clinical evaluation will be performed at baseline, three, six, and twelve months after enrollment. The assessments and scores used reflect the three components of the International Classification of Functioning, Disability and Health (ICF), some of them are tests regularly used in rehabilitation settings. Tests of motor function, cognition, and mood are included, as are tests of self-reported health-related quality of life. Primary outcome measure is a hand motor score, built by the sum of the hand items of the Fugl-Meyer Assessment as an objective measurement of hand function at 12 months after enrollment. Predictors of the primary outcome will be analyzed using linear regression analysis.PerspectiveThe results of IMPROVE will inform about the long-term dynamics of functional stroke recovery after patients' discharge from inpatient rehabilitation and will provide insights into the association of clinical and demographic factors with recovery of function.Trial registrationThe protocol is registered at ClinicalTrials.gov (NCT04119479).

Project description:BackgroundAlthough results from in vitro studies and small randomized controlled trials have shown positive effects of Dazhu hongjingtian injection (DZHJTI) on acute ischemic stroke (AIS), their generalizability to routine clinical practice remains to be established.ObjectiveThe primary aim of this study is to evaluate the effectiveness of DZHJTI treatment for AIS with regard to changes in the stroke-related neurological deficit from baseline to outpatient follow-up, mortality, subsequent vascular events, disability, and traditional Chinese medicine syndrome in real-world clinical settings. By monitoring for adverse events or significant changes in vital signs and laboratory parameters, we also aim to assess the safety of DZHJTI.MethodsThis prospective, multicenter cohort study plans to enroll 2000 patients with AIS within 14 days of symptom onset from 30 hospitals across China. Eligible patients will be followed up for 6 months after initiating medication treatments. The primary outcome will be the change in the National Institute of Health Stroke Scale score from baseline to outpatient follow-up. The secondary outcomes include overall mortality, stroke recurrence, new-onset major vascular events, global disability, and improvement of traditional Chinese medicine syndrome in 6 months. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of DZHJTI. An augmented inverse propensity weighted estimator will be used to reduce variability and improve accuracy in average treatment effects estimation.ResultsThe clinical trial registration was approved in October 2022, and the recruitment and enrollment of participants started in November 2022. The study's outcomes are expected to be published in 2025 in reputable, peer-reviewed health-related research journals.ConclusionsThis real-world cohort study is the first to assess the effectiveness and safety of DZHJTI in treating AIS. It may provide additional clinical evidence, including the duration of response, long-term drug effectiveness, and subgroup efficacy data. The study results will be valuable for clinicians and patients seeking optimal treatment for AIS and could lead to better use of DZHJTI and improved patient outcomes.Trial registrationITMCTR ITMCTR2022000005; http://tinyurl.com/554ns8m5.International registered report identifier (irrid)DERR1-10.2196/52447.

Project description:IntroductionRehabilitation is recognised as a cornerstone of multidisciplinary stroke care. Intensity of therapy is related to functional recovery although there is high variability on the amount of time and techniques applied in therapy sessions. There is a need to better describe stroke rehabilitation protocols to develop a better understanding of current practice increasing the internal validity and generalisation of clinical trial results. The aim of this study is to describe an intensive rehabilitation programme for patients with stroke in an inpatient rehabilitation facility, measuring the amount and type of therapies (physical, occupational and speech therapy) provided and reporting functional outcomes.Methods and analysisThis will be a prospective observational cohort study of patients with subacute stroke admitted to our inpatient rehabilitation facility during 2 years. A therapy recording tool was developed in order to describe the rehabilitation interventions performed in our unit. This tool was designed using the Delphi method, literature search and collaboration with senior clinicians. Therapists will record the time spent on different activities available in our unit during specific therapy sessions. Afterwards, the total time spent in each activity, and the total rehabilitation time for all activities, will be averaged for all patients. Outcome variables were divided into three different domains: body structure and function outcomes, activity outcomes and participation outcomes and will be assessed at baseline (admission at the rehabilitation unit), at discharge from the rehabilitation unit and at 3 and 6 months after stroke.Ethics and disseminationThis study was approved by the Medical Research Committee at Hospital del Mar Research Institute (Project ID: 34/C/2017). The results of this study will be presented at national and international congress and submitted for publication in peer-reviewed journals.Trial registration numberNCT04191109.

Project description:BackgroundStroke survivors report physical, cognitive, and psychological impairments, with a consequent limitation of participation. Participation is the most context-related dimension of functioning, but the literature on participation in Italian stroke patients is scant.AimThis study aimed to describe the recovery of participation six months after stroke with a validated Italian version of the Frenchay Activity Index (FAI) and to investigate potential correlates with higher participation scores.DesignThe study is a prospective observational study.SettingThe cohort of patients was enrolled in four intensive inpatient rehabilitation units of IRCCS Fondazione Don Carlo Gnocchi Onlus, Florence, Italy.PopulationAdults addressing postacute intensive inpatient rehabilitation after an ischemic or hemorrhagic stroke occurred within 30 days from recruitment were prospectively enrolled.MethodsData were collected at admission to intensive inpatient rehabilitation, and a six-month follow-up. The primary outcome was participation, measured by a validated Italian version of the FAI; only patients whose data included both anamnestic FAI and FAI at six months follow-up were included in this analysis. The data were analyzed by univariate and multivariate linear regressions.ResultsA cohort of 105 patients (median age 78 years [interquartile range, IQR=21]; 46.7% males) with completed FAI at follow-up were included in this study. The sample reported a FAI median score of 28 (IQR=8) at admission (referred to the participation in the 3-6 months before the stroke) and 13 (IQR=20) at follow-up. All items were significantly affected, with the exception of reading and making trips. The multivariate regression for all patients with good participation before the stroke (N.=101), showed that 6 months after the stroke a higher FAI Score was independently associated with better functioning in activities of daily living (modified Barthel Index) (B=0.133; P=0.015), and absence of cognitive impairment (B=4.755; P=0.027); a lower stroke severity in the postacute phase (NIHSS B=-0.832; P=0.001) and a higher prestroke FAI Score (B=0.410; P=0.028) were also independently related to follow-up FAI Score.ConclusionsIn our cohort of patients addressing postacute stroke rehabilitation, prestroke participation levels were on average good, while they were severely reduced six months after stroke for all the considered items except reading and making trips. Higher FAI at follow-up was independently associated with a higher functional level and no cognitive impairment at follow-up, with lower stroke severity in the postacute phase, as well as a higher anamnestic participation score.Clinical rehabilitation impactOur results suggest that investigating prestroke participation may be highly relevant to predict, and possibly address, participation recovery after stroke.

Project description:BackgroundParticipation represents the most relevant indicator of successful functioning after a severe traumatic brain injury (sTBI), since it correlates with a higher perceived quality of life by patients, their families, and healthcare professionals. Nevertheless, studies on Italian population are lacking.AimThe aim of this study was to evaluate the long-term participation and its early predictors in patients after a sTBI.DesignThis paper is an observational retrospective single-site study with long-term follow-up.SettingThe Intensive Rehabilitation Units (IRU) of the IRCCS Don Gnocchi Foundation, Florence, Italy.PopulationThe population included adults who were admitted to the IRU after a sTBI from August 2012 to May 2020 and who underwent a longitudinal follow-up between September 2021 and April 2022.MethodsPatients were contacted by a phone interview including participation assessment using the Community Integration Questionnaire (CIQ). When the patients were unable to respond, the caregiver was interviewed. Early predictors of long-term participation at admission and discharge from the IRU were assessed by a univariate and a multivariate analysis.ResultsAmong one hundred and forty-nine eligible patients, 3 died during their IRU stay, 35 patients were lost at the follow-up, 5 refused to participate in the interview and 46 died between discharge and follow-up. Sixty patients (men: 48 [80%]; age: 53.8 [IQR: 34.1] years; time postonset [TPO]: 36.5 [IQR: 22] days; education level: 8 [IQR: 5] years; mean time event-follow-up: 5.8 [IQR: 3.5] years) were included. The total CIQ Score was 11 (0-28): Home integration score 4 (0-10), Social integration 6 (0-12) and Productive activity 0 (0-6). Among 33 patients who worked or studied before the event, 19 (57.6%) returned to their previous activities. Only a younger age was associated with a better long-term participation both at admission (B=-0.210, P<0.001, R2=0.307) and at discharge (B=-0.173, P<0.001, R2=0.398).ConclusionsThis study reveals that under the same umbrella label of sTBI there are patients whose trajectories of long-term participation recovery are extremely heterogeneous. Further studies on larger samples are needed to identify patients with better participation recovery profiles, to customize their rehabilitation pathway.Clinical rehabilitation impactThe present study provides relevant information to help clinicians in giving accurate information to caregivers and drawing adequate rehabilitation pathways.

Project description:BackgroundNeurocognitive disorder (NCD) is common in stroke survivors. We aimed to identify clinically accessible imaging markers of stroke and chronic pathology that are associated with early post-stroke NCD.MethodsWe included 231 stroke survivors from the "Norwegian Cognitive Impairment after Stroke (Nor-COAST)" study who underwent a standardized cognitive assessment 3 months after the stroke. Any NCD (mild cognitive impairment and dementia) and major NCD (dementia) were diagnosed according to "Diagnostic and Statistical Manual of Mental Disorders (DSM-5)" criteria. Clinically accessible imaging findings were analyzed on study-specific brain MRIs in the early phase after stroke. Stroke lesion volumes were semi automatically quantified and strategic stroke locations were determined by an atlas based coregistration. White matter hyperintensities (WMH) and medial temporal lobe atrophy (MTA) were visually scored. Logistic regression was used to identify neuroimaging findings associated with major NCD and any NCD.ResultsMean age was 71.8 years (SD 11.1), 101 (43.7%) were females, mean time from stroke to imaging was 8 (SD 16) days. At 3 months 63 (27.3%) had mild NCD and 65 (28.1%) had major NCD. Any NCD was significantly associated with WMH pathology (odds ratio (OR) = 2.73 [1.56 to 4.77], p = 0.001), MTA pathology (OR = 1.95 [1.12 to 3.41], p = 0.019), and left hemispheric stroke (OR = 1.8 [1.05 to 3.09], p = 0.032). Major NCD was significantly associated with WMH pathology (OR = 2.54 [1.33 to 4.84], p = 0.005) and stroke lesion volume (OR (per ml) =1.04 [1.01 to 1.06], p = 0.001).ConclusionWMH pathology, MTA pathology and left hemispheric stroke were associated with the development of any NCD. Stroke lesion volume and WMH pathology were associated with the development of major NCD 3 months after stroke. These imaging findings may be used in the routine clinical setting to identify patients at risk for early post-stroke NCD.Trial registrationClinicalTrials.gov, NCT02650531 , Registered 8 January 2016 - Retrospectively registered.

Dataset Information

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

Publications

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

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