About this trial
Acquired brain injury (ABI) is the leading cause of death and disability worldwide. The degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome.
The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach.
In recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. The classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period.
The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. The proposed approach combines a principal component analysis (PCA) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions. By using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index (ERBI), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.
Eligibility criteria
Qualifiers
patients with clinical diagnosis of severe acquired brain injury of different etiology (traumatic, hemorrhagic vascular,ischemic vascular, anoxic, infectious, other etiology
interval since the acute occurrence that led to the clinical condition of ≤3 months duration
age of 18 years or older
informed consent signed by family member/caregiver/supporting caregiver
Disqualifiers
Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders
Trial design
Treatments tested in this trial
- Data collection
Treatment groups
Sponsors and collaborators
Istituto per la Ricerca e l'Innovazione Biomedica
Lead sponsor
Istituto S.Anna Crotone
Collaborator
IRCCS Centro Neurolesi Bonino Pulejo
Collaborator
Centro Cardinal Ferrari, Fontanellato, Parma
Collaborator
Fondazione Istituto G. Giglio, Cefalù (PA)
Collaborator
Habilita Istituto di Neuroriabilitazione, Zingonia (BG)
Collaborator
Casa Sollievo della Sofferenza IRCCS
Collaborator
IRCCS Istituto delle Scienze Neurologiche di Bologna
Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar
Collaborator
Fondazione Salvatore Maugeri
Collaborator
Istituti Clinici Zucchi
Collaborator
Istituto Clinico Humanitas
Collaborator
Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine
Collaborator
Montecatone Rehabilitation Institute S.p.A.
Collaborator
Ospedale Di Riabilitazione Fondazione Santa Lucia, Roma
Collaborator
Ospedale San Giovanni Battista, Foligno (PG)
Collaborator
Ospedale Ss. Trinità Di Fossano, Cuneo
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator