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Clinical Trials/NCT06162091
NCT06162091RecruitingNot Applicable

Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach.

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country190 target enrollmentStarted: January 10, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
190
Locations
1
Primary Endpoint
Glasgow Outcome Scale - Extended

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders

Outcomes

Primary Outcomes

Glasgow Outcome Scale - Extended

Time Frame: The test needs approximately 5 minutes to complete.

The Glasgow Outcome Scale - Extended (GOS-E) is a widely used outcome instrument to assess disability and recovery after brain injury. There are 8 categories in the scale: 1 - Dead, 2 - Vegetative State, 3 - Low Severe Disability, 4- Upper Severe Disability, 5- Low Moderate Disability, 6- Upper Moderate Disability, 7- Low Good Recovery and 8-Upper Good Recovery. The minimum score is 1 (dead) and the maximum score is 8 (upper good recovery).

Secondary Outcomes

  • Early Rehabilition Barthel Index(The test needs approximately 20 minutes to complete.)

Investigators

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antonio Cerasa

PhD, Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

Study Sites (1)

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