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.

Cross-validation of predictive models for functional recovery after post-stroke rehabilitation

“…Indeed, the retrospective nature of the study implied the use of a restricted selection of variables related to limited aspects of the patients’ rehabilitation. For this reason, a prospective observational design was developed for a multifactorial analysis of post-stroke patients’ characteristics [ 52 ] and their role for the prediction of functional recovery.…”

Design and implementation of a Stroke Rehabilitation Registry for the systematic assessment of processes and outcomes and the development of data-driven prediction models: The STRATEGY study protocol

“…In addition, this section contains information related to the location of the lesion, the side of the body affected by weakness/paresis, the possible presence of subluxated shoulder and edema of the affected hand, the type of treatment received during the acute phase (thrombolytic therapy, neurosurgical evacuation, etc. ), and the complications arising from the procedure, if any ( 20 ). Finally, the patient's premorbid functional level according to the modified Rankin Score (mRS) ( 21 ) is required.…”

“…The rehabilitation intervention is defined in an ICP based on the American Heart Association/American Stroke Association guidelines ( 17 , 37 ) and will provide, according to the national requirements, at least 3 h per day of specific rehabilitation including physiotherapy, neuropsychological therapy, and speech and dysphagia therapy, in addition to the assessment and training in the use of aids ( 20 ). Physiotherapy may also include robotic rehabilitation according to the individual rehabilitation plan defined by the interdisciplinary team ( 17 ).…”

Critical issue on the extinction and inattention subtest of NIHSS scale: an analysis on post-acute stroke patients attending inpatient rehabilitation

“…This work used data from a large prospective multicentric study aiming at the identification of potential predictors of functional recovery in post-acute stroke patients attending intensive inpatient rehabilitation in Fondazione Don Carlo Gnocchi (RIPS study) [ 17 ].…”

“…Patients with transitory ischemic attack or severe acquired brain injury, according to the Italian Guidelines of Rehabilitation published in 1998 [ 19 ], were excluded. Further details on the study protocol were described elsewhere [ 17 ].…”