Acquired Brain Injury and Neurorehabilitation: the Influence of Psychological Characteristics

NCT06661512 | Not Yet Recruiting

• 1 other identifier: 2024431_2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Brain Injury; Stroke Patients; TBI-Traumatic Brain Injury

Keywords

brain injury; neurorehabilitation; psychological characteristics

Outcome Measures

Primary Outcomes (14)

• Illness perception

  The Brief Illness Perception Questionnaire (BIPQ) 9 items. 1-10 score range for each item. Higher scores describe a higher degree of accord with the correspondent parameter of perception.

  4 months

• Motivation towards rehabilitation

  Motivation in stroke patients for rehabilitation scale (MORE) 17 items. 17-119 score range. Higher scores describe a higher degree of motivation towards rehabilitation.

  4 months

• Personal values

  Valued Living Questionnaire - Adapted (22 items) Part A: 11 items. 1-10 score range for each item. Higher scores describe a higher degree of identification towards the specific value. Part B: 11 items. 1-4 score range for each item. Higher scores describe a worse perceived impact in the specific value described after the brain injury.

  4 months

• Coping strategies

  Coping Orientation to Problems Experienced Inventory - Abbreviated (Brief COPE) 28 items. 28-112 score range. Higher scores describe a higher use of coping strategies.

  4 months

• Depressive symptomatology

  Depressive symptomatology measured by Patient Health Questionnaire-9 (PHQ-9) 9 items. 0-27 score range. Higher scores describe higher depressive symptomatology

  4 months

• Anxiety symptomatology

  Anxiety symptomatology measured by General Anxiety Disorder Questionnaire (GAD-7) 7 items. 0-21 score range. Higher scores describe higher anxiety symptomatology

  4 months

• Anosognosia

  Ad-hoc Anosognosia Questionnaire. 5 Items. 1-20 score range. Higher scores describe a higher perceived cognitive impairment.

  4 months

• Self-Esteem

  Rosenberg Self-Esteem scale (RSE) 10 items. 0-30 score range. Higher scores describe a higher degree of Self-Esteem.

  4 months

• Locus of control

  Sense of Control Scale. 8 items. 4 subscales with a range of -4 to +4. Locus of control refers to the perception of where control lies within their life and the causes of the events. A higher "internal good" subscale describes a higher tendency to attribute success towards oneself. A higher "external good" subscale describes a higher tendency to attribute success towards elements independent of oneself. A higher "internal bad" subscale describes a higher tendency to attribute failure towards oneself. A higher "external bad" subscale describes a higher tendency to attribute failure towards elements independent of oneself.

  4 months

• Self-Compassion

  Self-Compassion Scale Short Form (SCS-SF) 12 items. 12-60 score range. Higher scores describe a higher degree of Self-Compassion.

  4 months

• Injustice Experience

  Injustice Experience Questionnaire; IEQ 12 items. 0-48 score range. Higher scores describe a higher perception of injustice.

  4 months

• Dispositional hope

  Life Orientation Test (LOT-R): 6 items. 0-24 score range. Higher scores describe a higher degree of dispositional hope.

  4 months

• Posttraumatic Growth

  Posttraumatic Growth Inventory Short Form (PTGI-SF) 8 items. 0-40 score range. Higher scores describe a higher degree of Posttraumatic Growth.

  4 months

• Personality traits

  Big Five Inventory -2 (BFI-2-S) 30 items. 15 subscales with a 2-10 score range. 5 Personality traits with varying ranges of scores. Higher scores describe a higher intensity in that specific personality trait.

  4 months

Study Arms (1)

Patients with Acquired Brain Injury

Any patient who begins neurorehabilitation treatment at the Institut Guttmann Neurorehabilitation Hospital (Badalona) during the recruitment period will be considered a candidate for the study. The inclusion and exclusion criteria will then be checked, and those who meet the criteria will be offered participation in the study.

Other: Neurorehabilitation program

Interventions

Neurorehabilitation program OTHER

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).

Also known as: Neurorehabilitation, Rehabilitation, multidisciplinar rehabilitation

Patients with Acquired Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient who begins neurorehabilitation treatment at the Institut Guttmann Neurorehabilitation Hospital (Badalona) during the recruitment period will be considered a candidate for the study. The inclusion and exclusion criteria will then be checked, and those who meet the criteria will be offered participation in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Guttmann: lead

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

Related Publications (23)

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MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Interventions

Neurological Rehabilitation; Rehabilitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Miguel Espiña, Psychology

CONTACT

+34 934 977 700; mespina@guttmann.com

Alberto Garcia, Psychology

CONTACT

+34 934 977 700; agarciam@guttmann.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

ES (1)