Modeling outcome trajectories in patients with acquired brain injury using a non-linear dynamic evolution approach.
Simona Panunzi, Lucia Francesca Lucca, Antonio De Tanti...
https://pubmed.ncbi.nlm.nih.gov/37072538/Actively Recruiting
Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2025-05-01
190
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are studying patients with severe acquired brain injuries ABI, which are a leading cause of death and disability worldwide. The study aims to improve understanding and prediction of recovery progression during intensive rehabilitation care by using new statistical methods that analyze individual clinical changes over time. It also seeks to validate an updated clinical scale called the Early Rehabilitation Barthel Index ERBI to measure functional changes in these patients. Participants are patients admitted to intensive rehabilitation units within three months of their brain injury event. The study collects detailed data on demographics, clinical variables, responsiveness, cognitive function, disability, and care needs. Assessments include tools such as the Coma Recovery Scale, Levels of Cognitive Functioning, Disability Rating Scale, and the ERBI. These evaluations occur at two monthly timepoints up to six months, with monthly assessments continuing if hospitalization extends to 12 months. Throughout the study, researchers measure outcomes using the Glasgow Outcome Scale - Extended GOSE and the ERBI. Data collection involves monitoring clinical variables and medical devices present during rehabilitation. The study duration covers the inpatient rehabilitation period, with up to 12 assessment timepoints to track each patients clinical course and response to intensive care. This approach aims to better describe each patients recovery trajectory and assist future clinical practice.
CONDITIONS
Modeling Outcome in Patients With Acquired Brain Injuries
A
Antonio Cerasa
M
Maria Valeria Maiorana
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Istituto per la Ricerca e l'Innovazione Biomedica
Lead Sponsor
Istituto S.Anna Crotone
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on hospitalization length
Participants with severe acquired brain injuries admitted to intensive Rehabilitation Units are observed. Data on responsiveness, cognitive functioning, disability, and care needs are collected along with clinical variables and medical device presence.
Assessments every 2 months up to 6 months, then monthly up to 12 months if hospitalized longer
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Simona Panunzi, Lucia Francesca Lucca, Antonio De Tanti...
https://pubmed.ncbi.nlm.nih.gov/37072538/Istituto per la Ricerca e l'Innovazione Biomedica
Lead Sponsor
Istituto S.Anna Crotone
Collaborating Sponsor