NCT06661512Not yet recruiting
Acquired Brain Injury and Neurorehabilitation: the Influence of Psychological Characteristics
Source: ClinicalTrials.gov · Last updated 28 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 23 Oct 2024
- Start date
- Nov 2024
- Primary completion date
- Nov 2029
- Lead sponsor
- Institut Guttmann
- Diseases
- Stroke
- NCT number
- NCT06661512
What you commit to
- Study type: Observational
- Planned participants: 200
- From Nov 2024 to the primary completion date, Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presenting a neurological or psychiatric history.
- 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).
Other
- 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.
Who the study is looking for
- Age over 18 years
- Present acquired brain damage (stroke, head trauma, encephalopathy, brain tumor, or anoxia) after less than 6 months of evolution.
- Participants must present a cognitive alteration objectified through a neuropsychological examination.
- Be correctly oriented in person, space and time (assessed by psychometric tests).
- Have a good command of Spanish.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Guttmann Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.