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1. Effect of Rehabilitation Treatments on Disability in Persons With Disorders of Consciousness: A Propensity Score Study

Author

Sattin D., Leonardi M., Nelli B., Bramanti P., Marino S., Ferro S., Basaglia N., Guido D., Dolce G., Lucca L. F, Cortese M. D., Ermio C., Dattilo T. L., Capomolla S., Di Iasi G., Estraneo A., De Tanti A., Maradini N., Piperno R., Ferri A., Basaglia N, Bergonzoni A., Chiavaroli F., Di Marco F., Carli S., Biasutti E., Marin D., Formisano R., Rizza F., Pisarri F. M., Vichi R., D'Urso A., Grillo G., Leto A., Guerrasio M., Taliento C., Napolitano F., Castelli E., Lispi M. L., Diverio M., Barbieri C., Bini P. P., Angelino G., Dada O., Orlandi A., Pistarini C., Pisoni C., Manera M., Compostini A., Aiachini B., Pessina A., Musio A., Colombetti E., Taraschi S., Aluas M., Croci M., Negri M., Zucchella M. A., Guizzetti G. B., Salamone E., De Valle G., Caroppi S. M., Ramorino E., Salina D., Spannocchi G., Strazzer S., Villa F., Guarnerio C., Chiambretto P., Dartizio R., Feller S., Franzoni L., Giunco F., Massironi L., Azimonti R., Marcolli S. S., Meinecke C., Buse G., Marchesi V, Molteni F., Gramigna C., Lanfranchi M., Pisani L., Sozzi M., Borri G., Cannata A. P., Grillo A., Roca S., Locati D., Arenare F., Magnoni A., Perin C., Sussele M., Quintana T. Y., Camici M. E., Magistrelli F., Samueli T., San Felici L., Manganelli F., Vignati M., Bellanova L., Cattaneo N., Ferraro F., Olgiati E., Brizioli E., Vallasciani M., Gironelli L., Calderisi E., Novelli A., Scaramuzzo R., Perino C., Forno R., Zamponi E., Corna S., Ferrario S., Lamberti G., Rosso S., Colonna F., Navarro J., Trabacca A., Gennaro L., Bertolini A., Addante L., Amenduni M. T., Fiore P., Amoruso M. T., Colella D., Angelillo M. T., Melis G., Desogus G., Baglieri A., Galardi G., Sant'Angelo A., Posteraro F., Forte F., Logi F., Potenza F., Lino M., Zaccara G., Ragazzoni A., Chiaramonti R., March A., Grober G., Kaczor M., Zelger P, Mazzini N., Monti A., Zampolini M., Scarponi F., Avesani R., Salvi L., Tonin P., Cosentino E., Furlanetto N., Bordin M., Martinuzzi A., Buffoni M., Boldrini P., Semerjian M., Sattin, D, Leonardi, M, Nelli, B, Bramanti, P, Marino, S, Ferro, S, Basaglia, N, Guido, D, Dolce, G, Lucca, L, Cortese, M, Ermio, C, Dattilo, T, Capomolla, S, Di Iasi, G, Estraneo, A, De Tanti, A, Maradini, N, Piperno, R, Ferri, A, Bergonzoni, A, Chiavaroli, F, Di Marco, F, Carli, S, Biasutti, E, Marin, D, Formisano, R, Rizza, F, Pisarri, F, Vichi, R, D'Urso, A, Grillo, G, Leto, A, Guerrasio, M, Taliento, C, Napolitano, F, Castelli, E, Lispi, M, Diverio, M, Barbieri, C, Bini, P, Angelino, G, Dada, O, Orlandi, A, Pistarini, C, Pisoni, C, Manera, M, Compostini, A, Aiachini, B, Pessina, A, Musio, A, Colombetti, E, Taraschi, S, Aluas, M, Croci, M, Negri, M, Zucchella, M, Guizzetti, G, Salamone, E, De Valle, G, Caroppi, S, Ramorino, E, Salina, D, Spannocchi, G, Strazzer, S, Villa, F, Guarnerio, C, Chiambretto, P, Dartizio, R, Feller, S, Franzoni, L, Giunco, F, Massironi, L, Azimonti, R, Marcolli, S, Meinecke, C, Buse, G, Marchesi, V, Molteni, F, Gramigna, C, Lanfranchi, M, Pisani, L, Sozzi, M, Borri, G, Cannata, A, Grillo, A, Roca, S, Locati, D, Arenare, F, Magnoni, A, Perin, C, Sussele, M, Quintana, T, Camici, M, Magistrelli, F, Samueli, T, San Felici, L, Manganelli, F, Vignati, M, Bellanova, L, Cattaneo, N, Ferraro, F, Olgiati, E, Brizioli, E, Vallasciani, M, Gironelli, L, Calderisi, E, Novelli, A, Scaramuzzo, R, Perino, C, Forno, R, Zamponi, E, Corna, S, Ferrario, S, Lamberti, G, Rosso, S, Colonna, F, Navarro, J, Trabacca, A, Gennaro, L, Bertolini, A, Addante, L, Amenduni, M, Fiore, P, Amoruso, M, Colella, D, Angelillo, M, Melis, G, Desogus, G, Baglieri, A, Galardi, G, Sant'Angelo, A, Posteraro, F, Forte, F, Logi, F, Potenza, F, Lino, M, Zaccara, G, Ragazzoni, A, Chiaramonti, R, March, A, Grober, G, Kaczor, M, Zelger, P, Mazzini, N, Monti, A, Zampolini, M, Scarponi, F, Avesani, R, Salvi, L, Tonin, P, Cosentino, E, Furlanetto, N, Bordin, M, Martinuzzi, A, Buffoni, M, Boldrini, P, and Semerjian, M

Subjects
Adult, Male, 030506 rehabilitation, medicine.medical_specialty, Propensity score, medicine.medical_treatment, Physical Therapy, Sports Therapy and Rehabilitation, Disorders of consciousness, Severity of Illness Index, Disability Evaluation, 03 medical and health sciences, 0302 clinical medicine, Clinical Protocols, Severity of illness, medicine, Humans, Longitudinal Studies, Aged, Vegetative state, Rehabilitation, business.industry, Minimally conscious state, Recovery of Function, Disability Rating Scale, Middle Aged, medicine.disease, Treatment Outcome, Italy, Propensity score matching, Physical therapy, Consciousness Disorders, Female, Observational study, 0305 other medical science, business, 030217 neurology & neurosurgery
Abstract

To evaluate the effects of rehabilitation (physical and cognitive) treatments on the diagnosis severity and Disability Rating Scale (DRS) scores, adjusted for a number of potential confounders measured at baseline, in a large cohort of patients with disorders of consciousness across time.An observational, longitudinal (2 evaluations), multicenter project was made in 90 Italian centers.Patients (N=364) with a diagnosis of disorders of consciousness.Primary outcome was the severity of diagnosis, expressed on an ordinal scale (OtherMCSVSdeath). In the Other group were included patients who emerged from an MCS and recovered consciousness. The secondary outcome was the DRS score (range of 0-30 with 30 being the worst value). The DRS is a tool used to define the level of residual disability, commonly used to classify the level of functional impairment in patients with acquired brain injury. Both outcomes were measured for each wave.A total of 364 subjects having a complete set of demographic, clinical, and pharmacologic data were included in the propensity score (PS) analysis. Results showed that the rehabilitation treatments (physical and cognitive) reduced the clinical worsening over time in both severity diagnosis and DRS (around 6.5 points) in patients with disorders of consciousness across different propensity score strategies (ie, PS matching, PS adjustment, and PS-weighted procedures). In addition, cognitive protocols seem to be limited to patients with a median value of DRS=23.Our propensity score analysis suggests that rehabilitation treatment protocols seem effective and should be applied to a broader spectrum of patients with disorders of consciousness.

Published
2020

2. Effect of Rehabilitation Treatments on Disability in Persons With Disorders of Consciousness: A Propensity Score Study

Author

Sattin, D, Leonardi, M, Nelli, B, Bramanti, P, Marino, S, Ferro, S, Basaglia, N, Guido, D, Dolce, G, Lucca, L, Cortese, M, Ermio, C, Dattilo, T, Capomolla, S, Di Iasi, G, Estraneo, A, De Tanti, A, Maradini, N, Piperno, R, Ferri, A, Bergonzoni, A, Chiavaroli, F, Di Marco, F, Carli, S, Biasutti, E, Marin, D, Formisano, R, Rizza, F, Pisarri, F, Vichi, R, D'Urso, A, Grillo, G, Leto, A, Guerrasio, M, Taliento, C, Napolitano, F, Castelli, E, Lispi, M, Diverio, M, Barbieri, C, Bini, P, Angelino, G, Dada, O, Orlandi, A, Pistarini, C, Pisoni, C, Manera, M, Compostini, A, Aiachini, B, Pessina, A, Musio, A, Colombetti, E, Taraschi, S, Aluas, M, Croci, M, Negri, M, Zucchella, M, Guizzetti, G, Salamone, E, De Valle, G, Caroppi, S, Ramorino, E, Salina, D, Spannocchi, G, Strazzer, S, Villa, F, Guarnerio, C, Chiambretto, P, Dartizio, R, Feller, S, Franzoni, L, Giunco, F, Massironi, L, Azimonti, R, Marcolli, S, Meinecke, C, Buse, G, Marchesi, V, Molteni, F, Gramigna, C, Lanfranchi, M, Pisani, L, Sozzi, M, Borri, G, Cannata, A, Grillo, A, Roca, S, Locati, D, Arenare, F, Magnoni, A, Perin, C, Sussele, M, Quintana, T, Camici, M, Magistrelli, F, Samueli, T, San Felici, L, Manganelli, F, Vignati, M, Bellanova, L, Cattaneo, N, Ferraro, F, Olgiati, E, Brizioli, E, Vallasciani, M, Gironelli, L, Calderisi, E, Novelli, A, Scaramuzzo, R, Perino, C, Forno, R, Zamponi, E, Corna, S, Ferrario, S, Lamberti, G, Rosso, S, Colonna, F, Navarro, J, Trabacca, A, Gennaro, L, Bertolini, A, Addante, L, Amenduni, M, Fiore, P, Amoruso, M, Colella, D, Angelillo, M, Melis, G, Desogus, G, Baglieri, A, Galardi, G, Sant'Angelo, A, Posteraro, F, Forte, F, Logi, F, Potenza, F, Lino, M, Zaccara, G, Ragazzoni, A, Chiaramonti, R, March, A, Grober, G, Kaczor, M, Zelger, P, Mazzini, N, Monti, A, Zampolini, M, Scarponi, F, Avesani, R, Salvi, L, Tonin, P, Cosentino, E, Furlanetto, N, Bordin, M, Martinuzzi, A, Buffoni, M, Boldrini, P, Semerjian, M, Sattin D., Leonardi M., Nelli B., Bramanti P., Marino S., Ferro S., Basaglia N., Guido D., Dolce G., Lucca L. F, Cortese M. D., Ermio C., Dattilo T. L., Capomolla S., Di Iasi G., Estraneo A., De Tanti A., Maradini N., Piperno R., Ferri A., Basaglia N, Bergonzoni A., Chiavaroli F., Di Marco F., Carli S., Biasutti E., Marin D., Formisano R., Rizza F., Pisarri F. M., Vichi R., D'Urso A., Grillo G., Leto A., Guerrasio M., Taliento C., Napolitano F., Castelli E., Lispi M. L., Diverio M., Barbieri C., Bini P. P., Angelino G., Dada O., Orlandi A., Pistarini C., Pisoni C., Manera M., Compostini A., Aiachini B., Pessina A., Musio A., Colombetti E., Taraschi S., Aluas M., Croci M., Negri M., Zucchella M. A., Guizzetti G. B., Salamone E., De Valle G., Caroppi S. M., Ramorino E., Salina D., Spannocchi G., Strazzer S., Villa F., Guarnerio C., Chiambretto P., Dartizio R., Feller S., Franzoni L., Giunco F., Massironi L., Azimonti R., Marcolli S. S., Meinecke C., Buse G., Marchesi V, Molteni F., Gramigna C., Lanfranchi M., Pisani L., Sozzi M., Borri G., Cannata A. P., Grillo A., Roca S., Locati D., Arenare F., Magnoni A., Perin C., Sussele M., Quintana T. Y., Camici M. E., Magistrelli F., Samueli T., San Felici L., Manganelli F., Vignati M., Bellanova L., Cattaneo N., Ferraro F., Olgiati E., Brizioli E., Vallasciani M., Gironelli L., Calderisi E., Novelli A., Scaramuzzo R., Perino C., Forno R., Zamponi E., Corna S., Ferrario S., Lamberti G., Rosso S., Colonna F., Navarro J., Trabacca A., Gennaro L., Bertolini A., Addante L., Amenduni M. T., Fiore P., Amoruso M. T., Colella D., Angelillo M. T., Melis G., Desogus G., Baglieri A., Galardi G., Sant'Angelo A., Posteraro F., Forte F., Logi F., Potenza F., Lino M., Zaccara G., Ragazzoni A., Chiaramonti R., March A., Grober G., Kaczor M., Zelger P, Mazzini N., Monti A., Zampolini M., Scarponi F., Avesani R., Salvi L., Tonin P., Cosentino E., Furlanetto N., Bordin M., Martinuzzi A., Buffoni M., Boldrini P., Semerjian M., Sattin, D, Leonardi, M, Nelli, B, Bramanti, P, Marino, S, Ferro, S, Basaglia, N, Guido, D, Dolce, G, Lucca, L, Cortese, M, Ermio, C, Dattilo, T, Capomolla, S, Di Iasi, G, Estraneo, A, De Tanti, A, Maradini, N, Piperno, R, Ferri, A, Bergonzoni, A, Chiavaroli, F, Di Marco, F, Carli, S, Biasutti, E, Marin, D, Formisano, R, Rizza, F, Pisarri, F, Vichi, R, D'Urso, A, Grillo, G, Leto, A, Guerrasio, M, Taliento, C, Napolitano, F, Castelli, E, Lispi, M, Diverio, M, Barbieri, C, Bini, P, Angelino, G, Dada, O, Orlandi, A, Pistarini, C, Pisoni, C, Manera, M, Compostini, A, Aiachini, B, Pessina, A, Musio, A, Colombetti, E, Taraschi, S, Aluas, M, Croci, M, Negri, M, Zucchella, M, Guizzetti, G, Salamone, E, De Valle, G, Caroppi, S, Ramorino, E, Salina, D, Spannocchi, G, Strazzer, S, Villa, F, Guarnerio, C, Chiambretto, P, Dartizio, R, Feller, S, Franzoni, L, Giunco, F, Massironi, L, Azimonti, R, Marcolli, S, Meinecke, C, Buse, G, Marchesi, V, Molteni, F, Gramigna, C, Lanfranchi, M, Pisani, L, Sozzi, M, Borri, G, Cannata, A, Grillo, A, Roca, S, Locati, D, Arenare, F, Magnoni, A, Perin, C, Sussele, M, Quintana, T, Camici, M, Magistrelli, F, Samueli, T, San Felici, L, Manganelli, F, Vignati, M, Bellanova, L, Cattaneo, N, Ferraro, F, Olgiati, E, Brizioli, E, Vallasciani, M, Gironelli, L, Calderisi, E, Novelli, A, Scaramuzzo, R, Perino, C, Forno, R, Zamponi, E, Corna, S, Ferrario, S, Lamberti, G, Rosso, S, Colonna, F, Navarro, J, Trabacca, A, Gennaro, L, Bertolini, A, Addante, L, Amenduni, M, Fiore, P, Amoruso, M, Colella, D, Angelillo, M, Melis, G, Desogus, G, Baglieri, A, Galardi, G, Sant'Angelo, A, Posteraro, F, Forte, F, Logi, F, Potenza, F, Lino, M, Zaccara, G, Ragazzoni, A, Chiaramonti, R, March, A, Grober, G, Kaczor, M, Zelger, P, Mazzini, N, Monti, A, Zampolini, M, Scarponi, F, Avesani, R, Salvi, L, Tonin, P, Cosentino, E, Furlanetto, N, Bordin, M, Martinuzzi, A, Buffoni, M, Boldrini, P, Semerjian, M, Sattin D., Leonardi M., Nelli B., Bramanti P., Marino S., Ferro S., Basaglia N., Guido D., Dolce G., Lucca L. F, Cortese M. D., Ermio C., Dattilo T. L., Capomolla S., Di Iasi G., Estraneo A., De Tanti A., Maradini N., Piperno R., Ferri A., Basaglia N, Bergonzoni A., Chiavaroli F., Di Marco F., Carli S., Biasutti E., Marin D., Formisano R., Rizza F., Pisarri F. M., Vichi R., D'Urso A., Grillo G., Leto A., Guerrasio M., Taliento C., Napolitano F., Castelli E., Lispi M. L., Diverio M., Barbieri C., Bini P. P., Angelino G., Dada O., Orlandi A., Pistarini C., Pisoni C., Manera M., Compostini A., Aiachini B., Pessina A., Musio A., Colombetti E., Taraschi S., Aluas M., Croci M., Negri M., Zucchella M. A., Guizzetti G. B., Salamone E., De Valle G., Caroppi S. M., Ramorino E., Salina D., Spannocchi G., Strazzer S., Villa F., Guarnerio C., Chiambretto P., Dartizio R., Feller S., Franzoni L., Giunco F., Massironi L., Azimonti R., Marcolli S. S., Meinecke C., Buse G., Marchesi V, Molteni F., Gramigna C., Lanfranchi M., Pisani L., Sozzi M., Borri G., Cannata A. P., Grillo A., Roca S., Locati D., Arenare F., Magnoni A., Perin C., Sussele M., Quintana T. Y., Camici M. E., Magistrelli F., Samueli T., San Felici L., Manganelli F., Vignati M., Bellanova L., Cattaneo N., Ferraro F., Olgiati E., Brizioli E., Vallasciani M., Gironelli L., Calderisi E., Novelli A., Scaramuzzo R., Perino C., Forno R., Zamponi E., Corna S., Ferrario S., Lamberti G., Rosso S., Colonna F., Navarro J., Trabacca A., Gennaro L., Bertolini A., Addante L., Amenduni M. T., Fiore P., Amoruso M. T., Colella D., Angelillo M. T., Melis G., Desogus G., Baglieri A., Galardi G., Sant'Angelo A., Posteraro F., Forte F., Logi F., Potenza F., Lino M., Zaccara G., Ragazzoni A., Chiaramonti R., March A., Grober G., Kaczor M., Zelger P, Mazzini N., Monti A., Zampolini M., Scarponi F., Avesani R., Salvi L., Tonin P., Cosentino E., Furlanetto N., Bordin M., Martinuzzi A., Buffoni M., Boldrini P., and Semerjian M.

Abstract

Objective: To evaluate the effects of rehabilitation (physical and cognitive) treatments on the diagnosis severity and Disability Rating Scale (DRS) scores, adjusted for a number of potential confounders measured at baseline, in a large cohort of patients with disorders of consciousness across time. Design and Setting: An observational, longitudinal (2 evaluations), multicenter project was made in 90 Italian centers. Participants: Patients (N=364) with a diagnosis of disorders of consciousness. Main Outcome Measures: Primary outcome was the severity of diagnosis, expressed on an ordinal scale (Other

Published
2020

3. A Multidimensional Virtual Reality Neurorehabilitation Approach to Improve Functional Memory: Who Is the Ideal Candidate?

Author

Di Tella, Sonia, Isernia, Sara, Pagliari, Chiara, Jonsdottir, J., Castiglioni, C., Gindri, P., Gramigna, C., Canobbio, S., Salza, M., Molteni, Franco, Baglio, F., Di Tella S. (ORCID:0000-0002-2248-5120), Isernia S. (ORCID:0000-0002-0849-3984), Pagliari C., Molteni F., Di Tella, Sonia, Isernia, Sara, Pagliari, Chiara, Jonsdottir, J., Castiglioni, C., Gindri, P., Gramigna, C., Canobbio, S., Salza, M., Molteni, Franco, Baglio, F., Di Tella S. (ORCID:0000-0002-2248-5120), Isernia S. (ORCID:0000-0002-0849-3984), Pagliari C., and Molteni F.

Abstract

Aims: We aimed to identify the significant predictors of ecological memory amelioration after the Human Empowerment Aging and Disability (HEAD) rehabilitation program, a multidimensional treatment for chronic neurological diseases. Materials and Methods: Ninety-three patients with Parkinson disease (n = 29), multiple sclerosis (n = 26), and stroke (n = 38) underwent a multidimensional rehabilitation. We focused on changes after treatment on ecological memory (outcome measure) evaluated by Rivermead Behavioral Memory Test, Third Edition (RBMT-3). Minimal clinically important difference (MCID) after treatment were calculated for RBMT-3. The change score on RBMT-3 was categorized in positive effect, stabilization, or no effect of the treatment. Random forest classification identified who significantly benefited from treatment against who did not in terms of ecological memory functioning. Accordingly, logistic regression models were created to identify the best predictors of the treatment effect. A predicted probability value was derived, and the profile of the ideal candidate of HEAD protocol was shown by combining different ranks of significant predictors in a 3 × 3 matrix for each pair of predictors. Results: A significant number of cases reported positive effect of the treatment on ecological memory, with an amelioration over the MCID or a stabilization. The random forest analysis highlighted a discrete accuracy of prediction (>0.60) for all the variables considered at baseline for identifying participants who significantly benefited and who did not from the treatment. Significant logistic regression model (Wald method) showed a predictive role of Montreal Cognitive Assessment (MoCA; p = 0.007), 2-Minute Walk Test (2MWT; p = 0.038), and RBMT-3 (p < 0.001) at baseline on HEAD treatment effect. Finally, we observed a high probability of success in people with higher residual cognitive functioning (MoCA; odds ratio = 1.306) or functional mobility (2MWT; odds rati

Published
2021

4. Prescribing practice and off-label use of psychotropic medications in post-acute brain injury rehabilitation centres: A cross-sectional survey

Author

Pisa, Federica Edith, Cosano, Giorgia, Giangreco, Manuela, Giorgini, Tullio, Biasutti, Emanuele, Barbone, Fabio, Formisano, R., Buzzi, M. G., Pistarini, C., Aiachini, B., Basaglia, Nino, Montis, A., Lucca, L. F., Lombardi, F., Ranza, E., Vallasciani, M., Celentano, A., Naldi, A., Castellani, G., Lamberti, G., Lanzillo, B., Posteraro, F., Logi, F., Molteni, F., Lanfranchi, M., Gramigna, C., Bertagnoni, G., Dell'Oste, P., Tonin, P., Iaia, V., Sagliocco, L., Beatrici, M., Giunta, N., Dore, T., Galardi, G., Sant'Angelo, N., Piperno, R., Battistini, A., Zampolini, M., Scarponi, F., Sanna, V., Biella, A. M., Premoselli, S., Zaro, F., Bernasconi, K., Carnovali, M., Chierici, S., Antenucci, R., Salvi, G. P., Mazzini, N., Ventura, F., Lonati, M. C., Brianti, R., Mammi, P., Molinero, G., De Tanti, A., Bertolino, C., Boldrini, P., Bargellesi, S., and Tessari, A.

Subjects
Adult, Male, medicine.medical_specialty, Cross-sectional study, medicine.medical_treatment, Neuroscience (miscellaneous), Practice Patterns, Logistic regression, Off-label use, Rehabilitation Centers, NO, Pharmacotherapy, Arts and Humanities (miscellaneous), medicine, Antiepileptic agents, Prevalence, Developmental and Educational Psychology, Antipsychotics, Humans, Practice Patterns, Physicians', Psychiatry, Survey, Psychotropic Drugs, Rehabilitation, Physicians', Off-label, business.industry, Pharmacoepidemiology, Acquired brain injuries, Antidepressants, Prescribing, Psychotropic medications, Brain Injuries, Cross-Sectional Studies, Female, Italy, Middle Aged, Off-Label Use, Neurology (clinical), Odds ratio, Confidence interval, Emergency medicine, business
Abstract

Guidance on pharmacotherapy of neurobehavioural sequelae post-acquired brain injury (ABI) is limited. Clinicians face the choice of prescribing off-label. This survey assesses prescribing practice and off-label use of psychotropic medications in Italian brain injury rehabilitation centres and factors associated with atypical antipsychotics use.Centres were identified through the roster of the Italian Society for Rehabilitation Medicine. Information was collected through a structured questionnaire. This study calculated the prevalence of centres reporting to use off-label individual medications and unconditional logistic regression Odds Ratio (OR), with 95% confidence interval (95% CI) of atypical antipsychotics use.Psychotropic medications were commonly used. More than 50% of the 35 centres (participation ratio 87.5%) reported to use off-label selected antipsychotics, mostly for agitation (90.5%) and behavioural disturbances (19.0%), and antidepressants, mostly for insomnia (37.5%) and pain (25.0%). Atypical antipsychotic use was directly associated with age40 years (OR = 2.68; 95% CI = 1.25-5.76), recent ABI (1.74; 0.74-4.09), not with reported off-label use (0.98; 0.44-2.18).In clinical practice, the effectiveness and safety of medications, in particular off-label, should be systematically monitored. Studies are needed to improve the quality of evidence guiding pharmacotherapy and to evaluate effectiveness and safety of off-label prescribing.

Published
2015

5. Virtual Reality for Motor and Cognitive Rehabilitation From Clinic to Home: A Pilot Feasibility and Efficacy Study for Persons With Chronic Stroke.

Author

Jonsdottir J, Baglio F, Gindri P, Isernia S, Castiglioni C, Gramigna C, Palumbo G, Pagliari C, Di Tella S, Perini G, Bowman T, Salza M, and Molteni F

Abstract

Aims: Continuity of care is an important issue in healthcare for persons after stroke. The present multi-center pilot study investigates the feasibility and efficiency of an innovative approach, the Human Empowerment Aging and Disability (HEAD), for digital-health motor and cognitive rehabilitation. The approach is explored within an in-clinic context (ClinicHEAD) and in continuity of care (HomeHEAD) for persons after chronic stroke. Methods: Thirty-four outpatients with chronic stroke (mean age 55 years, SD 13.7) participated. The HEAD VR protocol was administered in two consecutive phases: Phase I in clinic (ClinicHEAD) consisting of 4 weeks of 12 supervised HEAD rehabilitation sessions (45-min), including motor, cognitive and dual task for all participants; Phase II at home (HomeHEAD) consisted of 60 sessions of the same VR activities, 5 times/week for 3 months. All participants in the ClinicHEAD were allocated (ratio 1:2) to continue with tele-monitored home rehabilitation (HH, N = 11) or to follow usual care (UC, N = 23). Blind evaluation was carried out at baseline, after ClinicHEAD, after 3 months of HomeHEAD and at 3 months Follow-up. Primary outcomes were functional mobility [2-min Walking Test (2MWT)] and cognition [Montreal Cognitive Assessment (MoCA)]. Feasibility and acceptance were assessed with adherence to treatment and the System Usability Satisfaction. Within group analyses were done with dependent samples t -tests, and between groups HomeHEAD comparisons were carried out on change scores with independent samples t -test ( p = 0.05, two tailed). Results: The HEAD protocol was feasible with good adherence both in the ClinicHEAD phase (92%) and HomeHEAD (89%) phase, along with good perceived system satisfaction. ClinicHEAD resulted in a significant increase in functional mobility (2MWT, p = 0.02) and cognition (MoCA, p = 0.003) and most secondary outcome variables. At 3 months follow up of HomeHEAD the HH&#95;group showed a further significantly greater maintenance of functional mobility with respect to UC&#95;group ( p = 0.04). Conclusion: The HEAD VR protocol was feasible in clinical and at home tele-rehabilitation for persons in the chronic phase after stroke. In clinic the approach was effective in augmenting motor and cognitive abilities and at home it was effective in longterm maintenance of functional mobility, indicating its usefulness in continuity of care. Clinical Trial Registration: ClinicalTrials.gov, NCT03025126., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Jonsdottir, Baglio, Gindri, Isernia, Castiglioni, Gramigna, Palumbo, Pagliari, Di Tella, Perini, Bowman, Salza and Molteni.)

Published
2021
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6. A Multidimensional Virtual Reality Neurorehabilitation Approach to Improve Functional Memory: Who Is the Ideal Candidate?

Author

Di Tella S, Isernia S, Pagliari C, Jonsdottir J, Castiglioni C, Gindri P, Gramigna C, Canobbio S, Salza M, Molteni F, and Baglio F

Abstract

Aims: We aimed to identify the significant predictors of ecological memory amelioration after the Human Empowerment Aging and Disability (HEAD) rehabilitation program, a multidimensional treatment for chronic neurological diseases. Materials and Methods: Ninety-three patients with Parkinson disease ( n = 29), multiple sclerosis ( n = 26), and stroke ( n = 38) underwent a multidimensional rehabilitation. We focused on changes after treatment on ecological memory (outcome measure) evaluated by Rivermead Behavioral Memory Test, Third Edition (RBMT-3). Minimal clinically important difference (MCID) after treatment were calculated for RBMT-3. The change score on RBMT-3 was categorized in positive effect, stabilization, or no effect of the treatment. Random forest classification identified who significantly benefited from treatment against who did not in terms of ecological memory functioning. Accordingly, logistic regression models were created to identify the best predictors of the treatment effect. A predicted probability value was derived, and the profile of the ideal candidate of HEAD protocol was shown by combining different ranks of significant predictors in a 3 × 3 matrix for each pair of predictors. Results: A significant number of cases reported positive effect of the treatment on ecological memory, with an amelioration over the MCID or a stabilization. The random forest analysis highlighted a discrete accuracy of prediction (>0.60) for all the variables considered at baseline for identifying participants who significantly benefited and who did not from the treatment. Significant logistic regression model (Wald method) showed a predictive role of Montreal Cognitive Assessment (MoCA; p = 0.007), 2 - Minute Walk Test (2MWT; p = 0.038), and RBMT-3 ( p < 0.001) at baseline on HEAD treatment effect. Finally, we observed a high probability of success in people with higher residual cognitive functioning (MoCA; odds ratio = 1.306) or functional mobility (2MWT; odds ratio = 1.013). Discussion: The HEAD program is a rehabilitation with effects on multiple domains, including ecological memory. Residual level of cognitive and/or motor functioning is a significant predictor of the treatment success. These findings confirm the intrinsic relationship subsisting between motor and cognitive functions and suggest the beneficial effects of physical activity on cognitive functions and vice versa ., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Di Tella, Isernia, Pagliari, Jonsdottir, Castiglioni, Gindri, Gramigna, Canobbio, Salza, Molteni and Baglio.)

Published
2021
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7. Effects of an Innovative Telerehabilitation Intervention for People With Parkinson's Disease on Quality of Life, Motor, and Non-motor Abilities.

Author

Isernia S, Di Tella S, Pagliari C, Jonsdottir J, Castiglioni C, Gindri P, Salza M, Gramigna C, Palumbo G, Molteni F, and Baglio F

Abstract

Parkinson's disease (PD) often leads to multifactorial motor and non-motor disabilities with resultant social restrictions. Continuity of care in this pathology, including a tailored home rehabilitation, is crucial to improve or maintain the quality of life for patients. The aim of this multicenter study was to test in a pilot sample of PD patients the efficiency and efficacy of the Human Empowerment Aging and Disability (HEAD) program. The virtual reality HEAD program was administered in two consecutive phases: (1) in clinic (ClinicHEAD, 12 45-minutes sessions, 3 sessions/week); (2) at home (HomeHEAD, 60 45-minutes sessions, 5 sessions/week). Thirty-one PD outpatients were enrolled [mean age (SD) = 66.84 (9.13)]. All patients performed ClinicHEAD, and after allocation (ratio 1:2) were assigned to the HomeHEAD or the Usual Care (UC) group. Motor, cognitive and behavioral outcome measures were assessed at enrollment (T0), at hospital discharge (T1), at 4 (T2) and 7 (T3) months after baseline. After ClinicHEAD (T1 vs. T0 comparison) a significant ( p < 0.05) improvement in functional mobility, balance, upper limb mobility, global cognitive function, memory, quality of life and psychological well-being was observed. After the HomeHEAD intervention there was an additional enhancement for upper limb mobility. At T3 follow-up, the UC group that did not continue the HEAD program at home showed a worsening with respect to the HomeHEAD group in balance and functional mobility. Furthermore, in the HomeHEAD group, a positive association was observed between adherence, mental and physical health (SF-12). A trend was also registered between adherence and positive affect. The digital health patient-tailored rehabilitation program resulted in improving motor and non-motor abilities and quality of life in clinical setting, enhancing the motor function in telerehabilitation at home, and maintaining the non-motor abilities and quality of life at follow-up. In the near future, people with PD can be supported also at home with individualized rehabilitation strategies for a better quality of life and wellbeing along with lower costs for society., (Copyright © 2020 Isernia, Di Tella, Pagliari, Jonsdottir, Castiglioni, Gindri, Salza, Gramigna, Palumbo, Molteni and Baglio.)

Published
2020
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8. Efficiency and Patient-Reported Outcome Measures From Clinic to Home: The Human Empowerment Aging and Disability Program for Digital-Health Rehabilitation.

Author

Isernia S, Pagliari C, Jonsdottir J, Castiglioni C, Gindri P, Gramigna C, Palumbo G, Salza M, Molteni F, and Baglio F

Abstract

Background: The recent exponential growth of Digital Health (DH) in the healthcare system provides a crucial transformation in healthcare, answering to alarming threats related to the increasing number of Chronic Neurological Diseases (CNDs). New long-term integrated DH-care approaches, including rehabilitation, are warranted to address these concerns. Methods: The Human Empowerment Aging and Disability (HEAD) rehabilitation program, a new long-term integrated care including DH-care system, was evaluated in terms of efficiency and patient-reported outcome measures (PROMs) in 107 CND patients (30 with Parkinson's Disease, PD; 32 with Multiple Sclerosis, MS; 45 with stroke in chronic stage). All participants followed 1-month of HEAD rehabilitation in clinic (ClinicHEAD: 12 sessions, 3/week), then 1:3 patient was consecutively allocated to 3-months telerehabilitation at home (HomeHEAD: 60 sessions, 5/week). Efficiency (i.e., adherence, usability, and acceptability) and PROMs (i.e., perceived functioning in real-world) were analyzed. Results: The rate of adherence to HEAD treatment in clinic (≥90%) and at home (77%) was high. Usability of HEAD system was judged as good (System Usability Scale, median 70.00) in clinic and even more at home (median 80.00). Similarly, administering the Technology Acceptance Model 3 questionnaire we found high scores both in clinic/at home (Usefulness, mean 5.39 ± 1.41 SD/mean 5.33 ± 1.29 SD; Ease of use, mean 5.55 ± 1.05 SD/ mean 5.45 ± 1.17 SD, External Control, mean 4.94 ± 1.17 SD/mean 5.07 ± 1.01 SD, Relevance, mean 5.68 ± 1.29 SD/mean 5.70 ± 1.13 SD and Enjoyment, mean 5.70 ± 1.40 SD/mean 6.01 ± 1.08 SD). After ClinicHEAD, participation and autonomy in daily routine was maintained or even ameliorated (PD and stroke > MS). Whereas, increased functionality and participation in the MS group was found only after HomeHEAD intervention. Discussion: Our results suggest that a tele-health-based approach is both feasible and efficient in providing rehabilitation care to CNDs from clinic to home. Increasing and maintaining participation as well as autonomy in daily routine are promising findings that open up scenarios for the continuity of care at home through DH-care for CNDs., (Copyright © 2019 Isernia, Pagliari, Jonsdottir, Castiglioni, Gindri, Gramigna, Palumbo, Salza, Moltenia and Baglio.)

Published
2019
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9. Predicting Functional Recovery in Chronic Stroke Rehabilitation Using Event-Related Desynchronization-Synchronization during Robot-Assisted Movement.

Author

Caimmi M, Visani E, Digiacomo F, Scano A, Chiavenna A, Gramigna C, Molinari Tosatti L, Franceschetti S, Molteni F, and Panzica F

Subjects
Adult, Aged, Electroencephalography, Electromyography, Female, Humans, Male, Middle Aged, Stroke physiopathology, Task Performance and Analysis, Young Adult, Recovery of Function physiology, Robotics instrumentation, Signal Processing, Computer-Assisted instrumentation, Stroke Rehabilitation instrumentation, Stroke Rehabilitation methods, Upper Extremity physiology
Abstract

Although rehabilitation robotics seems to be a promising therapy in the rehabilitation of the upper limb in stroke patients, consensus is still lacking on its additive effects. Therefore, there is a need for determining the possible success of robotic interventions on selected patients, which in turn determine the necessity for new investigating instruments supporting the treatment decision-making process and customization. The objective of the work presented in this preliminary study was to verify that fully robot assistance would not affect the physiological oscillatory cortical activity related to a functional movement in healthy subjects. Further, the clinical results following the robotic treatment of a chronic stroke patient, who positively reacted to the robotic intervention, were analyzed and discussed. First results show that there is no difference in EEG activation pattern between assisted and no-assisted movement in healthy subjects. Even more importantly, the patient's pretreatment EEG activation pattern in no-assisted movement was completely altered, while it recovered to a quasi-physiological one in robot-assisted movement. The functional improvement following treatment was large. Using pretreatment EEG recording during robot-assisted movement might be a valid approach to assess the potential ability of the patient for recovering.

Published
2016
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