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Clinical Trials in Spain / NCT06661512
Starting soon Observational

Acquired Brain Injury and Neurorehabilitation: the Influence of Psychological Characteristics

NCT06661512 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-11
Last updated
2024-10-28

Condition(s) studied

Brain InjuryStroke PatientsTBI-Traumatic Brain Injury

Investigational drug(s) / intervention(s)

Neurorehabilitation program

Neurorehabilitation program: Participants will participate in a neurorehabilitation program, consisting in a structured, interdisciplinary approach designed to help individuals improve their functional abilities following acquired brain injury. The goal is to optimize the individual's physical, cognitive, emotional, and social functioning to enhance their quality of life The neurorehabilitation program includes, physical rehabilitation, occupational therapy, speech therapy and neuropsychological rehabilitation (cognitive, emotional and behavioral).

Study summary

Acquired brain damage generates motor, cognitive, behavioral and emotional deficits. Neurorehabilitation aims to reduce these deficits and develop compensatory strategies that increase the person's functionality. However, the success of neurorehabilitation process varies and is influenced by the type of injury, the characteristics of the patient or the treatment received. Despite all the studies about patient characteristics, psychological aspects currently continue to be a field to be explored.

The main objective of the study is to study the psychological characteristics of people with brain damage. Secondary objectives include analyzing its link with other indicators, exploring possible differences depending on the etiology of brain damage, assessing its evolution during neurorehabilitation and exploring its prognostic value.

To carry out this prospective longitudinal observational study, adult patients with acquired brain damage to less than 6 months of evolution who present an objective cognitive alteration will be selected. Patients with a neurological or psychiatric history will be excluded.

Patients included in the study will be administered computerized questionnaires at the beginning of the neurorehabilitation program. The same questionnaires will be administered again 2 months later. In those hospitalized patients who subsequently continue outpatient treatment, a third administration will be performed (2 months after the second administration).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age over 18 years 2. Present acquired brain damage (stroke, head trauma, encephalopathy, brain tumor, or anoxia) after less than 6 months of evolution. 3. Participants must present a cognitive alteration objectified through a neuropsychological examination. 4. Be correctly oriented in person, space and time (assessed by psychometric tests). 5. Have a good command of Spanish. Exclusion Criteria: 6. Presenting a neurological or psychiatric history. 7. Presenting a language disorder or severe visual-perceptive disorder - hemineglect - that prevents participation in the study (does not allow for correct administration of the questionnaire). 8. A posteriori criterion (once the study has begun): Answering incorrectly to any of the validity items included in the questionnaire. This situation leads to automatic exclusion from studies. The initial neuropsychological examination will be used to check whether participants meet inclusion criteria 3 and 4, as well as exclusion criterion 7. This examination includes orientation tests (subtest of the Barcelona Orientation Test), language tests (subtests of the Barcelona Word Repetition Test, Word Naming and Command Comprehension Test) and visual-perception tests (subtests of the Barcelona Superimposed Figures Test). Only those participants who correctly answer all the items will be selected.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institut Guttmann Badalona Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06661512 on ClinicalTrials.gov ↗ ← All trials in Spain