Brain Injuries Clinical Trial
Official title:
Efficacy of a Computerized Program of Cognitive Rehabilitation of Attention in People With Acquired Brain Injury (ABI): Pilot Study
NCT number | NCT04214314 |
Other study ID # | 001b |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 30, 2019 |
Est. completion date | November 2023 |
Acquired Brain Injury (ABI) is a sudden lesion in the brain, not congenital or perinatal,caused by various pathologies.According to the National Statistics Institute,in Spain 78% of people suffering from ABI are a result of stroke,and 22% due to Traumatic Brain Injuries (TBIs) and other causes.The ABI is in most cases with problems of cognitive,physical,emotional,social,family and work.Of all these problems,attentional alterations are one of the most frequent and disabling for these participants,with a prevalence of 30-62%.However,there are currently no specific programs for the rehabilitation of attentional processes in people with ABI in Spain.So recently,a program focused on the rehabilitation of NeuronUp APT attentional processes has been developed,based on the theoretical model of Sohlberg and Mateer,which considers attention as a multidimensional cognitive function that is hierarchically organized.This program includes a large group of rehabilitation activities in contexts similar to those of daily life.Objectives:1)Evaluate the effectiveness of the NeuronUp APT attentional training program for the improvement of the attention problems presented by participants with ABI;2)determine whether the improvement of attention problems in participants with ABI causes changes in their functioning emotional and quality of life and 3)determine whether the improvement of the attention problems in participants with ABI causes changes in the functionality of the participants and, consequently, in the activities of their daily lives.Method:This is a randomized clinical trial, 46 participants with ABI between the ages of 18-65 will be recruited; 23 participants will be assigned to the experimental group (integral rehabilitation+NeuronUp APT) and the other 23 to the control group (integral rehabilitation) randomly,using a simple randomization method.Both groups will be evaluated before the start of the intervention, after the end of the intervention and 6 months after the intervention, thus collecting sociodemographic information,clinical characteristics of the disease, cognitive screening measures,emotional functioning test,functional and quality of life.Conclusions:It is hoped to achieve a transfer of the gains obtained,through the training of the attention through the NeuronUp APT rehabilitation program,to other aspects of cognitive,emotional functioning and quality of life.It is also expected that these people improve their attention problems in their daily lives.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | November 2023 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1) Be between 18 and 65 years old at the time of the intervention; 2) enter the Acquired Brain Injury Unit of the Aita Menni hospital with a diagnosis of ABI;3) have been hospitalized in the Aita Menni unit for at least 3 weeks;4) the patient must know how to read and write; 5) obtain a score below the 10th percentile in at least one of the attention tests in the screening phase and 6) not present post traumatic amnesia at the start of the study, in the case of patients with TBI. Exclusion Criteria: 1) Present severe behavioral alterations; 2) have a previous history of neurological disease, psychiatric disorders, intellectual disability, learning disorders and / or substance abuse; 3) have a diagnosis of aphasia; 4) present a score less than or equal 23 in the Mini-mental State Examination (MMSE) and 5) present severe motor or sensory problems that may limit the performance of the tests and the attention rehabilitation program. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Aita Menni | Mondragón | Guipúzcoa |
Lead Sponsor | Collaborator |
---|---|
Ikerbasque - Basque Foundation for Science |
Spain,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short attention test (BTA): changes in the measure before the intervention (pre-intervention), after the intervention (post-intervention) and six months after the intervention | The test is used as a measure of divided attention. It can be used in people between 17 and 82 years, it is of individual application with an approximate duration of 10 minutes. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | Trail Making Test (TMT A-B): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | The test is used to evaluate attention, psychomotor speed, cognitive flexibility, visual search and executive functions. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | Test of Colors and Words (Stroop Test): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It provides information on the inhibitory capacity of the subject and its resistance to stimulus interference. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | Symbol and digit test (SDMT): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is a test that involves the conversion of geometric designs into written and / or spoken numerical responses. The test is applied from 8 years to 78 and can be individually or collectively. Because the test consists of geometric figures and numbers, and these are universal symbols of written language, the SDMT test is relatively free of cultural and idiomatic factors and can be applied in different countries and languages. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | PASAT test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | This test is a measure of cognitive function that evaluates the speed and flexibility of the processing of auditory information, as well as the ability to calculate. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | Bells Test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | The Bells Test is used to detect visual inattention in children and adults and it consists of a 21.5 × 28 cm sheet of paper on which seven lines of 35 distractor figures (e.g., bird, key, apple, mushroom, car) and five target figures (bells) are presented. The target figures are arranged so that five of each appears in seven equal columns on the page | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | Attention Test D2: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | This test is a cancellation task that evaluates the basic processes of selective attention and mental concentration. This instrument also reflects three components of attentional behavior: the speed or amount of work, the quality of work and the relationship between speed and accuracy of attention. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Primary | Minimental State Examination (MMSE): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | MMSE is a short and quantitative measurement that can be used to detect cognitive deficits, to assess its severity at a given time, to follow the course of cognitive changes over time and to evaluate the response to a treatment. Several investigations have shown that the MMSE is a reliable and valid instrument in different patient samples and the general population.The scores of MMSE are 0 to 30. In this study the participants need to have a score major 23 for participate. Because, if the score is less or equal 23 in this test, the participant can have an important cognitive deficits. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Hopkins Verbal Learning Test - Revised (HVLT-R): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is one of the most used tests to measure learning and verbal memory in the neuropsychological clinical evaluation. It consists of a list of 12 words extracted from 3 different semantic categories. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Test of the complex figure of Rey: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is a very useful instrument to evaluate the perceptual organization and visual memory in people with brain damage, evaluate the ability to organize and plan strategies for problem solving, as well as the viso-constructive capacity. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Modified test of classification of Wisconsin cards (M-WCST): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is a variation of the Wisconsin Card Classification test created to assess abstract reasoning and the ability to adapt cognitive strategies to the changing environment. It is an individual application test for adults between 18 and 90 years and between the administration time and score add approximately 12 minutes. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Boston Denomination Test (BNT): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | The test consists of naming 60 sheets presented in order of difficulty. Its test-retest reliability coefficients are above 0.77 and has demonstrated good internal consistency with indexes greater than 0, 78. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Phonological and Semantic Verbal Fluency Test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | These types of tests are highly sensitive to brain damage, so they are commonly administered to people with neurological damage (TBI, multiple sclerosis, dementias, etc.).These tests require the person to be flexible, organize the information and exercise inhibition when necessary. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | European Brain Injury Questionnaire (EBIQ): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is a self-report that gives us a relative measure of the subjective experience of the cognitive, emotional and social difficulties experienced by people with ABI. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Questionnaire of attention problems: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | This is a questionnaire prepared by the department's research team for this project with the objective of obtaining a measure of how attention problems affect the activities of the patient's daily life, said questionnaire consists of 7 questions, one of them multiple choice. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Moss Attention Rating Scale (MARS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is made up of 22 items, through which an observational rating of the behaviors related to care is obtained. It is useful in evaluations of people with TBI (moderate - severe). | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Patient Health Questionnaire (PHQ-9): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | This is a 9-item questionnaire that evaluates the presence of major depressive disorder based on the criteria of the diagnostic and statistical manual of mental disorders (DSM-IV-R). Difference between other depressive symptoms, positive depressive symptoms and negative depressive symptoms. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Generalized Anxiety Disorders Scale (GAD-7): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | This is a 7-item scale that evaluates the presence of generalized anxiety disorder based on the criteria of the diagnostic and statistical manual of mental disorders (DSM-IV-R). The scale has been adapted to Spanish. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Quality of life scale (SF-36): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | consists of 36 questions through which the quality of life related to physical and emotional health, the interference of physical and emotional problems in social life is evaluated, the degree of vitality, energy or fatigue and the general perception of health. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Life Satisfaction Scale (SWLS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is a global measure of satisfaction with life that consists of 5 items. Different studies have used this scale for the evaluation of life satisfaction of people with TBI. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention | |
Secondary | Disability Rating Scale (DRS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention | It is an instrument that evaluates functional recovery in patients with moderate and severe traumatic brain injuries from coma to their return to society, taking into account cognitive function. | Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention |
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