Predicting the functional outcome of intensive inpatient rehabilitation after stroke: results from the RIPS Study.

BACKGROUND: The complexity of stroke sequelae, the heterogeneity of outcome measures and rehabilitation pathways, and the lack of extensively validated prediction models represent a challenge in predicting stroke rehabilitation outcomes. AIM: To prospectively investigate a multidimensional set of variables collected at admission to inpatient post-stroke rehabilitation as potential predictors of the functional level at discharge. DESIGN: Multicentric prospective observational study. SETTING: Patients were enrolled in four Intensive Rehabilitation Units (IRUs). POPULATION: Patients were consecutively recruited in the period December 2019-December 2020 with the following inclusion criteria: aged 18+, with ischemic/haemorrhagic stroke, and undergoing inpatient rehabilitation within 30 days from stroke. METHODS: This is a multicentric prospective observational study. The rehabilitation pathway was reproducible and evidence-based. The functional outcome was disability in activities of daily living, measured by the modified Barthel Index (mBI) at discharge. Potential multidimensional predictors, assessed at admission, included demographics, event description, clinical assessment, functional and cognitive profile, and psycho-social domains. The variables statistically associated with the outcome in the univariate analysis were fed into a multivariable model using multiple linear regression. RESULTS: A total of 220 patients were included (median [IQR] age: 80 [15], 112 women, 175 ischemic). Median mBI was 26 (43) at admission and 62.5 (52) at discharge. In the multivariable analysis younger age, along with better functioning, fewer comorbidities, higher cognitive abilities, reduced stroke severity, and higher motor functions at admission, remained independently associated with higher discharge mBI. The final model allowed a reliable prediction of discharge functional outcome (adjusted R2=77.2%). CONCLUSIONS: The model presented in this study, based on easily collectable, reliable admission variables, could help clinicians and researchers to predict the discharge scores of the global functional outcome for persons enrolled in an evidence-based inpatient stroke rehabilitation program. CLINICAL REHABILITATION IMPACT: A reliable outcome prediction derived from standardized assessment measures and validated treatment protocols could guide clinicians in the management of patients in the subacute phase of stroke and help improve the planning of the rehabilitation individualized project.

Italian translation and transcultural validation of an assessment tool for community ambulation in stroke survivors: the modified Functional Walking Categories (mFWC).

BACKGROUND: Community ambulation ability is one of the most important functional loss after stroke. The assessment of the level of community walking plays an important role in the multidimensional bio-psycho-social approach, to improve quality of life and social participation of stroke survivors. The modified Functional Walking Categories (mFWC) is a worldwide widely used tool to assess community ambulation in stroke survivors, but no Italian version is yet available. OBJECTIVE: To cross-culturally adapt the mFWC into Italian and to assess its validity and reliability. METHODS: According to the international guidelines, a multistep translation and cultural adaptation were conducted and revised by a committee of experts. Patients admitted to intensive inpatient rehabilitation with a sub-acute stroke were recruited. Inter- and intra-rater reliability and construct validity were studied. RESULTS: Sixty patients with sub-acute stroke were prospectively enrolled in this study. Findings showed almost perfect intra- and inter-rater reliability (k = 1.000 [95% CI 1.000-1.000] and k = 0.984 [95% CI 0.955-1.000], respectively). The construct validity of the scale was satisfactory, as 100.0% a-priori hypotheses were met. CONCLUSIONS: The Italian mFWC offers a valid tool for measuring community ambulation in stroke patients. Our work provides a validated and a cross-cultural adapted Italian version of the mFWC to accurately measure community ambulation both in clinical and research settings in Italy.

Factors influencing trunk control recovery after intensive rehabilitation in post-stroke patients: a multicentre prospective study.

BACKGROUND: Trunk control plays a crucial role in the stroke rehabilitation, but it is unclear which factors could influence the trunk control after an intensive rehabilitation treatment. OBJECTIVES: To study which demographic, clinical and functional variables could predict the recovery of trunk control after intensive post-stroke inpatient rehabilitation. METHODS: Subjects with acute, first-ever stroke were enrolled and clinical and data were collected at admission and discharge. The primary outcome was considered the trunk control measured by the Trunk Control Test (TCT). The data were analyzed by a univariate and multivariate logistic regressions. RESULTS: Two hundred forty-one post-stroke patients were included. All baseline variables significantly associated to TCT at discharge in the univariate analysis (i.e. gender, NIHSS neglect item at admission, presence of several complexity markers, TCT total score at admission, NIHSS total score, pre-stroke modified Rankin Scale, Fugl-Meyer Assessment motor and sensitivity score) were entered in the multivariate analysis. The multivariate regression showed that age (p = .003), admission NIHSS total score (p = .001), admission TCT total score (p < .001) and presence of depression (p = .027) independently influenced the TCT total score at discharge (R2 = 61.2%). CONCLUSIONS: Age, admission neurological impairment (NIHSS total score), trunk control at the admission (TCT total score), and presence of depression independently influenced the TCT at discharge. These factors should be carefully assessed at the baseline to plan a tailoring rehabilitation treatment achieving the best trunk control performance at discharge.

Intra- and inter-rater reliability of the Italian Fugl-Meyer assessment of upper and lower extremity.

PURPOSE: To assess the intra- and inter-rater reliability motor and sensory functioning, balance, joint range of motion and joint pain subscales of the Italian Fugl-Meyer Assessment (FMA) Upper Extremity (FMA-UE) and Lower Extremity (FMA-LE) at the item- subtotal- and total-level in patients with sub-acute stroke. MATERIALS AND METHODS: The FMA was administered to 60 patients with sub-acute stroke (mean age ± SD = 75.4 ± 10.7 years; 58.3% men) and independently rated by two physiotherapists on two consecutive days. Intra- and inter-reliability was studied by a rank-based statistical method for paired ordinal data to detect any systematic or random disagreement. RESULTS: The item-level intra- and inter-rater reliability was satisfactory (>70%). Reliability level >70% was achieved at subscale and total score level when one- or two-points difference was considered. Systematic disagreements were reported for five items of the FMA-UE, but not for FMA-LE. CONCLUSIONS: The Italian version of the FMA showed to be a reliable instrument that can therefore be recommended for clinical and research purposes.Implications for rehabilitationThe FMA is the gold standard for assessing stroke patients' sensorimotor impairment worldwide.The Italian Fugl-Meyer Assessment of Upper Extremity (FMA-UE) and Lower Extremity (FMA-LE) is substantially reliable within and between two raters at the item, subtotal, and total score level in patients with sub-acute stroke.The use of FMA in the Italian context will provide an opportunity for international comparisons and research collaborations.

Italian translation and cross-cultural validation of an assessment tool for participation in stroke survivors: the Frenchay Activities Index.

PURPOSE: Participation needs to be assessed objectively, to state accurate rehabilitation objectives. The Frenchay Activities Index (FAI) is a widely used tool to measure participation in stroke patients. To date, no cross-culturally validated Italian version of FAI is available. This study provides a translation and cross-cultural adaptation of FAI into Italian, assessing its validity and reliability in sub-acute stroke patients. METHODS: According to international guidelines, a multistep translation and cultural adaptation protocol of forward and backward translations was conducted by qualified linguists and independent native English translators and revised by a healthcare committee. Patients admitted to intensive inpatient rehabilitation after stroke were recruited. Structural validity, reliability (internal consistency, inter- and intra-rater reliability and measurement error), and construct validity were studied. RESULTS: One hundred and seventy-three patients were included in this study. No significant observations in terms of comprehensibility and conceptual equivalence of the FAI Italian version emerged. The exploratory factorial analysis revealed the presence of two subscales (i.e., domestic chores and work/leisure). The internal consistency resulted good for the first and second subscale (α = 0.821 and 0.716, respectively). Intra- and inter-reliability showed an ICC > 0.90 for both subscales. SEM = 5.75% and 2.33% and MDC = 15.85% and 6.48% were found for the first and second subscale, respectively. Construct validity of first subscale was satisfactory, as 100.0% a priori hypotheses were met, while for the second subscale it was moderate, as 66.6% a priori hypotheses were respected. CONCLUSION: FAI-I provides a tool for professionals to measure participation in Italian stroke patients in health and social care settings.

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

OBJECTIVES: This study aims to evaluate the diagnostic performance of NIHSS extinction and inattention item, compared to the results of the Oxford Cognitive Screen (OCS) heart subtest. Additionally, the possible role of the NIHSS visual field subtest on the NIHSS extinction and inattention subtest performance is explored and discussed. METHODS: We analysed scores on NIHSS extinction and inattention subtest, NIHSS visual field subtest, and OCS heart subtest on a sample of 118 post-stroke patients. RESULTS: Compared to OCS heart subtest, the results on NIHSS extinction and inattention subtest showed an accuracy of 72.9% and a moderate agreement level (Cohen's kappa = 0.404). Furthermore, a decrease in NIHSS accuracy detecting neglect (61.1%) was observed in patients with pathological scores in NIHSS visual field item. CONCLUSIONS: Extreme caution is recommended for the diagnostic performance of extinction and inattention item of NIHSS. Signs of neglect may not be detected by NIHSS, and may be confused with visual field impairment. TRIAL REGISTRATION: This study refers to an observational study protocol submitted to ClinicalTrials.gov with identifier: NCT03968627 . The name of the registry is "Development of a National Protocol for Stroke Rehabilitation in a Multicenter Italian Institution" and the date of the registration is the 30th May 2019.

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 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.

Development and implementation of a stroke rehabilitation integrated care pathway in an Italian no profit institution: an observational study.

BACKGROUND: To standardize assessment and coordinate processes in stroke rehabilitation, an integrated care pathway (ICP) was developed in an Italian Rehabilitation and Research Institution by a knowledge-translation interdisciplinary process, from evidence-based guidelines to rehabilitation practice. The ICP was implemented in two pilot Tuscan rehabilitation Centers. AIM: The purpose of this study was to describe ICP development and assess the ICP effects on postacute stroke inpatient rehabilitation outcomes. DESIGN: Prospective observational study, before and after comparison. SETTING: Two Tuscan inpatient rehabilitation centers. POPULATION: Patients accessing either centers for intensive rehabilitation after acute stroke. METHODS: Two cohorts were prospectively recruited before (2015-2017) and after (2018) implementation of the pathway. The primary outcome was change in activities of daily living disability, assessed by the modified Barthel Index (mBI) from admission to discharge. Secondary outcomes included length of stay (LOS), adverse outcomes, and changes in communication ability, trunk control, pain, ambulation, bladder catheter (Y/N), bedsores (Y/N). RESULTS: In 2015-2017, 443 postacute stroke patients (mean age 77±11 years, 47% women), while in 2018, 84 patients (mean age 76±13 years, 61% women) were admitted to the two facilities. Comparing the 2018 vs. the 2015-17 cohort, the mean mBI increase was not substantially different (26 vs. 24 points), nor were LOS (37±18 vs. 36±16 days), adverse outcomes, discharge destination, and improvement of ambulation, pain, and communication (P>0.05). Instead, a significantly higher improvement of trunk control (trunk control test: 69.6±33.2 vs. 79.0±31.3, P=0.019), and a higher percentage of bedsore resolution (13% vs. 5%, P=0.033), and bladder catheter removal (37% vs. 17% P<0.001) were observed in 2018 vs. 2015-2017. CONCLUSIONS: Compared to prior practice, ICP was associated to improvement of trunk control recovery, bladder catheter removal, and bedsores resolution. Further ICP implementation on a larger scale is needed to verify improvements of stroke inpatient rehabilitation outcomes. CLINICAL REHABILITATION IMPACT: An evidence-based stroke rehabilitation ICP was interdisciplinary developed and implemented in two rehabilitation centers of a multicenter Italian health group. ICP implementation as to inpatient intensive postacute stroke rehabilitation was associated to improved trunk control recovery, bladder catheter removal, and bedsore resolution. Further ICP implementation will allow multicenter studies and quality benchmarking.