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The main purpose of this project is to identify the medium-term prognostic factors for patients with Severe Acquired Brain Injuries and evaluate their impact.
The secondary aim is to create a system of continuous assessment of the quality of care for each rehabilitation unit.
For each unit involved, it will be collected these data :
Statistical models will be implemented, in order to identify prognostic factors that could predict the probability to observe three events, which represent objectives of the rehabilitation process: decannulation, trunk control and total feeding by os. These events should be evaluated four months after the acute episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults admitted in participating Rehabilitation Units for Severe Acquired Brain Injuries | Adults admitted in study's participants Rehabilitation Units for Severe Acquired Brain Injuries from the 1st of July 2021 to the 31st of December 2023. Patients entered into these units more than 14 weeks after the acute event are excluded |
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| Measure | Description | Time Frame |
|---|---|---|
| Tracheostomy tube | Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days | july 2021 - june 2025 |
| Trunk control | Achievement of trunk control, for which the patient must be able to maintain the sitting position for at least 60 seconds, on a rigid surface, with the lower limbs in support, but without support from the upper limbs and without rear support of the trunk | july 2021 - june 2025 |
| Total feeeding by os | Oral feeding with sufficient caloric intake | july 2021 - june 2025 |
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Inclusion Criteria:
Exclusion Criteria:
- patients admitted more than 14 weeks after the acute event
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All patients admitted in the Rehabilitation Units for Severe Acquired Brain Injuries participating in the study during the 30 months of enrollment provided by the research
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulia Irene Ghilardi | Contact | 035 4535389 | giulia_irene.ghilardi@marionegri.it |
| Name | Affiliation | Role |
|---|---|---|
| Guido Bertolini | Istituto Di Ricerche Farmacologiche Mario Negri | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale SS. Antonio e Biagio e C. Arrigo | Recruiting | Alessandria | 15121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40046674 | Derived | Nattino G, Acler M, Bargellesi S, Bertagnoni G, Carrara G, De Tanti A, Estraneo A, Ghilardi GI, Lavezzi S, Lombardi F, Lucca LF, Mancuso M, Montis A, Mule C, Navarro J, Posteraro F, Rossato E, Simoncini L, Bertolini G. A prospective multicenter study on prognostic factors and quality of care in Severe Acquired Brain Injury rehabilitation units: a project from the Tiresia network. Front Neurol. 2025 Feb 19;16:1527533. doi: 10.3389/fneur.2025.1527533. eCollection 2025. |
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Protecting the privacy policy, all the data that underlie results in a publication will be shared. The scientific commettee of the study has to decide the criteria and the best way to share them
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| Centro di Riabilitazione Terranuova Bracciolini | Recruiting | Arezzo | 52025 | Italy |
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| Ospedale civile di Baggiovara | Recruiting | Baggiovara | 41126 | Italy |
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| ASST Papa Giovanni XXIII | Recruiting | Bergamo | Italy |
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| Ospedale Maggiore | Recruiting | Bologna | 40133 | Italy |
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| Fondazione Poliambulanza | Recruiting | Brescia | 25124 | Italy |
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| Ospedale S. Michele, AO Brotzu | Active, not recruiting | Cagliari | 09047 | Italy |
| Ospedale S. Sebastiano | Recruiting | Correggio | 42015 | Italy |
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| Istituto S. Anna | Recruiting | Crotone | 88900 | Italy |
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| Azienda Ospedaliero-Universitaria di Ferrara | Recruiting | Ferrara | 44124 | Italy |
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| Fondazione Don Gnocchi | Recruiting | Florence | Italy |
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| Ospedale di Foligno | Not yet recruiting | Foligno | 06034 | Italy |
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| Montecatone Rehabilitation Institute SpA | Recruiting | Imola | Italy |
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| USL Toscana Nord Ovest | Recruiting | Lucca | 55100 | Italy |
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| IRCCS S. Maria Nascente, Fondazione don Gnocchi | Recruiting | Milan | 20148 | Italy |
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| Istituto Palazzolo, Don Gnocchi | Not yet recruiting | Milan | 20149 | Italy |
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| Ospedale Sacro Cuore don Calabria | Recruiting | Negrar | 37024 | Italy |
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| ATS Sardegna | Not yet recruiting | Oristano | 09170 | Italy |
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| Ospedale Buccheri La Ferla Fatebenefratelli | Not yet recruiting | Palermo | 90123 | Italy |
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| Centro Cardinal Ferrari | Not yet recruiting | Parma | 43012 | Italy |
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| AUSL Piacenza | Recruiting | Piacenza | Italy |
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| Centro di riabilitazione E. Spalenza, Don Gnocchi | Recruiting | Rovato | 25038 | Italy |
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| Ospedale "Casa Sollievo della Sofferenza" | Recruiting | San Giovanni Rotondo | Italy |
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| Fondazione Don Gnocchi, Sant'Angelo dei Lombardi | Recruiting | Sant'Angelo dei Lombardi | Italy |
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| IRCCS Telese, ICS Maugeri | Not yet recruiting | Telese Terme | 82037 | Italy |
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| Ospedale Riabilitativo Villa Rosa | Recruiting | Trento | 38057 | Italy |
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| A.ULSS n.8 Berica | Recruiting | Vicenza | 36100 | Italy |
|
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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