Yeah, stroke is challenging. Because you haven't gotten off your duffs and created objective diagnoses that can lead to EXACT REHAB PROTOCOLS delivering 100% recovery. And until you do that you will never solve stroke leaving survivors permanently disabled.
Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol
Associated Data
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.
Introduction
Stroke is one of the major causes of death and permanent disability in Western countries, with a growing impact on public health (1). Thrombolytic therapy represents a great progress in the treatment of the acute phase of cerebrovascular disease, but only a minority of patients are eligible and can actually receive it, and, on the whole, this improvement does not balance the steady increase of stroke prevalence, both for the greater longevity of the population and for the lower mortality in the acute phase. There is wide diversity in stroke severity and stroke patients (2); of those surviving a stroke, about 65% present disability and receive rehabilitation. However, deficits in activity and participation persist in about 30% of the survivors even after rehabilitation (3), and, to date, very little is known about long-term functional outcomes (4, 5). Stroke recovery is heterogeneous in its nature, but the intensity, quality, and timing of rehabilitation play a central role in the patients' recovery and in their reintegration into the community after a stroke (6). An interdisciplinary, multi-professional intensive rehabilitation approach tackling not only sensorimotor impairment but also all the possible associated problems, such as language, swallowing, sphincter and respiratory impairments as well as pain, depression, cognitive and/or communication disability, is highly recommended (6). As to physiotherapy, intensive exercise, consisting of increased repetitions and aerobic training, seems to optimize motor and functional outcome in stroke survivors with post-acute sensorimotor disability (7). However, in Italy, the implementation of interdisciplinary intensive rehabilitation for stroke survivors is highly diverse across the country. This is due to a remarkable interregional and intraregional heterogeneity in the rehabilitation pathways, leading to a high risk for inequalities and suboptimal care (8) as well as to major difficulties in quality assessment and benchmarking.
Moreover, the complex nature of stroke sequelae requires several assessment instruments to correctly quantify every residual symptom and adequately respond to the patients' needs during the acute, the post-acute, and the community-living stroke phase. Standardized assessment tools need to be easy to use and comprehensive of all the elements necessary to accurately address the great range of different rehabilitation needs (9).
In this context, the conduction of multicentric studies and clinical trials might be particularly difficult. Indeed a standardized, reproducible, and uniform outcome assessment, as much as a well-defined rehabilitation pathway, is necessary to investigate the effects of a single intervention during intensive interdisciplinary rehabilitation as well as for investigating individual predictors of response to treatment. Predictors may also differ for different interventions (10), suggesting clues to personalize rehabilitation and, possibly, improve rehabilitation outcomes (11). To date, a large representative cohort study focusing on individual variability of response to a standardized, evidence-based treatment is lacking (12), and predictive factors of individual response to treatment are still largely unexplored (13).
The significant inter-individual variability in the outcome of neurorehabilitation is related to the quality of medical and rehabilitation treatment in the different phases (14). However, a complex interaction of baseline health status (age and previous comorbidity) and physical/cognitive state, stroke subtype and severity as well as changes in brain structural architecture (15) is believed to largely influence stroke outcome. Furthermore, complications in the early-acute phase (16) also predict outcomes, for instance, post-stroke epilepsy (PSE) that has a high recurrence rate (30%) 1 year after the acute event (17) with approximately 50% of patients experiencing a recurrence of symptoms during a follow-up period of 47 months (18).
Recent studies have also highlighted the importance of some neurophysiological biomarkers, such as resting state electroencephalography (EEG) and motor evoked potentials (MEP), as predictors of motor recovery after a stroke (19). Finally, a recent line of research is focusing on genetic biomarkers since some genes, in particular, genetic variations of the brain-derived neurotrophic factor (BDNF) (20), catechol-O-methyl transferase polymorphism (21), and dopamine receptor (22), have been implicated in stroke recovery and prognosis (23).
Fondazione Don Carlo Gnocchi (FDG) is one of the largest Italian scientific rehabilitation and research institutions (SRRI) that have recently developed and implemented an evidence-based interdisciplinary integrated care pathway (ICP) for post-acute stroke inpatient rehabilitation (24). After a pilot study confirming feasibility and suggesting improved outcomes of the ICP compared to previous practice, this has been adopted in four intensive rehabilitation units (IRUs) in order to standardize the outcome definition and the process of care according to national and international stroke rehabilitation guidelines (6, 25).
This paper describes the background and methods of a multicenter study protocol to prospectively investigate outcomes and baseline predictors (including biomarkers) of function, activity, and participation of patients undergoing intensive interdisciplinary inpatient rehabilitation after a stroke. The purpose of the study will be to describe the influence of several clinical, functional, and psychosocial factors, neurophysiological patterns, and genetic polymorphisms on the recovery of body functions, activity, and participation of stroke survivors undergoing rehabilitation, both in the late-acute phase (discharged from IRUs) and in the chronic phase (6 months after a stroke).
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