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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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BACKGROUND: Despite progress in surgery and care, hip fracture (HF) remains a catastrophic event, burdened with high risk of mortality and disability. This study aims at identifying predictors of recovering ambulation after intensive inpatient rehabilitation within the Tuscany Region HF rehabilitation pathway. METHODS: All HF patients referred from acute care to the two Massa-Carrara Rehabilitation facilities January 2015-June 2017 were enrolled. Comorbidity Total Score (CIRS) defined high- or low-care setting referral. Recovery of ambulation, with or without aid, (assessed by SAHFE) was the primary outcome. Personal data, comorbidity, cognitive (MMSe) and pre-fracture function (mRANKIN) were recorded on admission. Outcomes included hospital readmission, length of stay (LOS) and home discharge. Urinary catheter, bedsores, disability (modified Barthel Index-mBI), communication disability (CDS), trunk control (TCT), pain (NRS), and ambulation were recorded (admission-discharge). RESULTS: Of 352 patients enrolled (age 83.9 ± 7.1; 80% women), 1 died and 6 were readmitted to acute-care hospital; 97% patients referred to high-care, and 64% referred to low-care, presented moderate-high comorbidity on admission. Median LOS was 22 days; 95% patients were discharged back home; daily functional gain (mBIscore/LOS) was 1.3 ± 0.7. Patients who recovered ambulation on discharge were 84%. Older age, higher comorbidity, bladder catheter, impaired trunk control, worse cognitive and functional status on admission, and pre-fracture disability were associated to poor outcome, but only higher comorbidity and impaired communication on admission predicted failure to recover ambulation on discharge. CONCLUSION: In HF patients entitled to intensive inpatient rehabilitation, moderate-high comorbidity and impaired communication are frequent findings and predict rehabilitation failure.