Efficacy of a Computerized Program of Cognitive Rehabilitation of Attention in People With Acquired Brain Injury (ABI)

NCT ID: NCT04214314

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2023-11-30

Brief Summary

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.

Detailed Description

General objectives

1)Evaluate the effectiveness of the NeuronUp APT attention training program for the improvement of the attention problems presented by participants with ABI. 2)Determine whether the improvement of the attention problems in the group of participants with ABI, leads to an improvement in the cognitive performance of these participants in the other areas of cognitive functioning. 3)Determine if the improvement of attention problems in participants with ABI, causes changes in their emotional functioning and quality of life. 4)Determine if 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 life.

Specific objectives

1)Determine if there are significant differences between the groups in the scores of the attention tests over time. 2)Determine if there are significant differences between the groups in the scores of the neuropsychological tests that measure memory, executive functions and language over time. 3)Determine if there are significant differences between the groups in the scores of the scale of attention problems in daily life after the intervention.4)Determine if there are significant differences between the groups in the scores of the scale of quality of life over time. 5)Determine if there are significant differences between the groups in the scores of the scales of emotional functioning over time. 6)Determine if there are significant differences between the groups in the scores of the functional functioning scales over time.

Hypothesis

1)Participants in the experimental group will present significantly higher scores in the neuropsychological tests that evaluate the attention at the end of the intervention and six months later compared to the control group. 2)Participants in the experimental group will present significantly higher scores on neuropsychological tests that assess memory, language and executive functions at the end of the intervention and 6 months later compared to the control group. 3)Participants in the experimental group will present significantly lower scores on the scales that measure attention problems in daily life, both at the end of the intervention and at six months later compared to the control group.4)The gains observed in the attentional functioning of the participants of the experimental group will be reflected in an improvement of their emotional functioning, their functional status and their quality of life at the end of the intervention and six months later compared to the control group.

Brief Summary of approach and methodology

• Participants: 46 participants will be recruited with stroke, aged between 18 and 65, who attend the Acquired Brain Injury Unit of the Aita Menni Hospital (Mondragón-Arrasate); specifically, the investigators will focus on participants whose diagnosis is moderate-severe TBI and patients with a diagnosis of stroke, in the last three years. To determine the sample size, a statistical power analysis was carried out with the G *Power program. For this, the Cohen criteria have been taken into account, so that an effect size of 0.45 (large for the ANOVA statistic) and alpha and beta values of 0.05 and 0.95, respectively, have been established. The information will be obtained from each participant at three specific times: before to the start of the intervention, after completing the implementation of the program and six months after the end of the program.

The information that will be collected in each of these three times is as follows:

• Sociodemographic data Information on age, years of schooling (number of years), gender (male vs. female), occupation (employed, unemployed, student, retired, etc.), marital status (single, married, free union) will be collected through the interview, laterality (right-handed, left-handed, ambidextrous) and monthly economic income (total amount of income).
• Clinical characteristics, screening tests: Primary Outcomes Measures.
• Study of cognitive functioning, study of the attentional state in the participant's daily life, study of the emotional state of participants, study of the emotional state of participants,Quality of life study,Study of functional status: Secondary Outcomes Measures.

NeuronUp APT attentional program

The model by which NeuronUp APT is governed is the clinical rehabilitation model described by Sholberg and Mateer, which considers attention as a main cognitive function of a multidimensional character that is hierarchically organized.NeuronUp APT is composed of 80 activities, based on activities of daily living whose objective is to achieve the greatest possible ecology and a true transfer of cognitive training to the daily activities of patients. All activities are computerized and can be performed on any electronic device, computer, mobile and tablet, allowing patients to continue training from home.

Since it is based on the traditional clinical model, program activities are organized according to the type of attention in blocks of 20 exercises, as follows:

• Sustained attention: Exercises in which a series of visual or auditory stimuli are presented to the participant, depending on the activity, of which there is a Target Stimulus (TS). The stimuli appear one by one on the electronic device, and each time the participant sees or hears the TS, the person must press on the screen. For example, in one of the activities the participant is instructed to delete the photos of his/her cat from the mobile. To do this, different photos appear on the screen of a mobile phone, and the participant's task is to press each time the photo of the cat comes out.
• Selective attention: Exercises in which in addition to visual or auditory stimuli other distracting stimuli are presented, such as ambient noise in the case of visual activities, or videos in the case of auditory activities. For example, in one of the activities is simulated that the participant is in a shopping center and must attend to the license plates of the cars that are being announced by public address system because the cars are badly parked. To do this, a video of a shopping center full of people is presented while listening to the auditory stimuli, in this case, the license plates of the cars, and the task of the participant is to press on the screen every time hear a registration ending in a certain number.
• Alternate attention: Exercises in which there are two TSs that alternate. For example, in one of the activities, the participant is told that is at an airport and must collect his/her bags and those of a relative. To do this, the participant must first attend and press each time see a specific suitcase (first TS), and when hears an alarm the participant must change the instruction and press each time see another particular suitcase (second TS).
• Divided attention: Exercises in which a visual and auditory stimulus are simultaneously presented, which the participant must process at the same time. For example, in one of the activities, the participant is instructed to attend the traffic signs and press every time sees the signal that indicates the possible appearance of deer to reduce speed. In addition, the participant must follow the Global Positioning System (GPS) instructions and press each time the instruction indicates the presence of a radar. Since the way to respond to the stimuli is by pressing on the screen, the two TSs are never presented at the same time, since otherwise would not be possible to determine which of the two stimuli the participants are attending.

The difficulty of each of the tasks will be progressively increased, depending on the number of stimuli and the time spent, through 5 levels. So, in the lower levels the tasks last less and contain less stimuli than in the upper ones. Thus, during the training process, patients complete all levels of sustained attention activities, and then start the selective attention block, then the alternate attention, and finally the divided attention. For the implementation of NeuronUp APT, the neuropsychologist will need to make use of a neurorehabilitation web platform.

Statistical analysis by objectives

In the first place, preliminary analyzes will be carried out by means of a t-test to determine if there are differences in the sociodemographic variables between groups (sex, age, schooling).Subsequently, multiple analyzes of 2 X 3 ANOVAS will be carried out, both of repeated measures intra and between groups, where the first factor will be the group (experimental and control) and the second factor the time (baseline, after completing the implementation of the intervention with NeuronUp APT and six months after the end of the intervention) and the dependent variables, the scores on the measures used.

Conditions

Brain Injuries

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

The control group will continue to receive the integral rehabilitation provided by the center.

No interventions assigned to this group

Experimental

The participants of the experimental group, in addition to the integral rehabilitation of the center will receive the training of the attention through NeuronUp APT. There will be 3 rehabilitation sessions of one hour a week for about a month and a half or two.

NeuronUp APT attentional program

Intervention Type: BEHAVIORAL

NeuronUp APT attentional program consists of 4 types of attention with 20 activities each and 5 different levels of difficulty per activity. These 20 activities will be divided into two blocks (block A or block B) of 10 activities each and then, randomly, participants will be administered one block or another. The administration of the entire program is approximately one month and a half or 2 months per patient, with sessions of one hour, 3 times per week.

Interventions

NeuronUp APT attentional program

NeuronUp APT attentional program consists of 4 types of attention with 20 activities each and 5 different levels of difficulty per activity. These 20 activities will be divided into two blocks (block A or block B) of 10 activities each and then, randomly, participants will be administered one block or another. The administration of the entire program is approximately one month and a half or 2 months per patient, with sessions of one hour, 3 times per week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ikerbasque - Basque Foundation for Science

OTHER

Sponsor Role: lead

Responsible Party

Juan Carlos Arango Lasprilla

Neuropsychologist- Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Carlos Arango Lasprilla

Role: PRINCIPAL_INVESTIGATOR

Ikerbasque - Basque Foundation for Science

Locations

Hospital Aita Menni

Arrasate / Mondragón, Guipúzcoa, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Juan Carlos Arango Lasprilla

Role: CONTACT

jcalasprilla@gmail.com

+34 688884061

Luis Castaño González

Role: CONTACT

luisantonio.castanogonzalez@osakidetza.eus

+34 946006073

Facility Contacts

Naiara Mimetza

Role: primary

nmimentza.aitamenni@hospitalarias.es

References

Arango-Lasprilla, J., Olabarrieta-Landa, L., Laseca-Zaballa, G., Castrillón -Carvajal, J., & Usuga - Ramos, D. (2019).Traumatic Brain Injury in adults. In Brain damage (pp. 151-201). Mexico D.F: Modern Manual.

Reference Type: BACKGROUND

Areny-Balagueró, M., García-Molina, A., Roig-Rovira, T., Tormos, J., & Jodar-Vicente, M. (2016). Relationship between sensation seeking and patient decision making with harm Acquired brain. Psychology: Advances of Discipline, 10 (1), 25-33.

Reference Type: BACKGROUND

Bate AJ, Mathias JL, Crawford JR. Performance on the Test of Everyday Attention and standard tests of attention following severe traumatic brain injury. Clin Neuropsychol. 2001 Aug;15(3):405-22. doi: 10.1076/clin.15.3.405.10279.

Reference Type: BACKGROUND

PMID: 11778779 (View on PubMed)

Carvajal Castrillón, J., & Restrepo Pelaez, A. (2013). Theoretical foundations and intervention strategies in neuropsychological rehabilitation in adults with acquired brain damage. CES Psychology Magazine, 6 (2), 135-148.

Reference Type: BACKGROUND

Cermak SA, Katz N, McGuire E, Greenbaum S, Peralta C, Maser-Flanagan V. Performance of Americans and israelis with cerebrovascular accident on the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA). Am J Occup Ther. 1995 Jun;49(6):500-6. doi: 10.5014/ajot.49.6.500.

Reference Type: BACKGROUND

PMID: 7645662 (View on PubMed)

Cicerone KD. Remediation of "working attention" in mild traumatic brain injury. Brain Inj. 2002 Mar;16(3):185-95. doi: 10.1080/02699050110103959.

Reference Type: BACKGROUND

PMID: 11874612 (View on PubMed)

de Norena D, Rios-Lago M, Bombin-Gonzalez I, Sanchez-Cubillo I, Garcia-Molina A, Tirapu-Ustarroz J. [Effectiveness of neuropsychological rehabilitation in acquired brain injury (I): attention, processing speed, memory and language]. Rev Neurol. 2010 Dec 1;51(11):687-98. Spanish.

Reference Type: BACKGROUND

PMID: 21108231 (View on PubMed)

Fish J, Manly T, Emslie H, Evans JJ, Wilson BA. Compensatory strategies for acquired disorders of memory and planning: differential effects of a paging system for patients with brain injury of traumatic versus cerebrovascular aetiology. J Neurol Neurosurg Psychiatry. 2008 Aug;79(8):930-5. doi: 10.1136/jnnp.2007.125203. Epub 2007 Nov 26.

Reference Type: BACKGROUND

PMID: 18039889 (View on PubMed)

Galbiati S, Recla M, Pastore V, Liscio M, Bardoni A, Castelli E, Strazzer S. Attention remediation following traumatic brain injury in childhood and adolescence. Neuropsychology. 2009 Jan;23(1):40-9. doi: 10.1037/a0013409.

Reference Type: BACKGROUND

PMID: 19210031 (View on PubMed)

García-Molina, A., Gómez, A., Rodríguez, P., Sánchez-Carrión, R., Zumarraga, L., Enseñat, A., ... Roig-Rovira, T. (2010). Clinical program of cognitive telerehabilitation in craniocerebral trauma. Trauma Fund MAPFRE, 21 (1), 58-63.

Reference Type: BACKGROUND

Greenwald BD, Kapoor N, Singh AD. Visual impairments in the first year after traumatic brain injury. Brain Inj. 2012;26(11):1338-59. doi: 10.3109/02699052.2012.706356. Epub 2012 Aug 16.

Reference Type: BACKGROUND

PMID: 22897509 (View on PubMed)

Heilman, K., & Valenstein, E. (1993). Clinical Neuropsychology (3rd ed.). New York: Oxford University Press.

Reference Type: BACKGROUND

Ison, M. (2011). Intervention program to improve the attention capacities in Argentine schoolchildren. International Journal of Psychological Research, 4 (2), 72-79.

Reference Type: BACKGROUND

Khan F, Baguley IJ, Cameron ID. 4: Rehabilitation after traumatic brain injury. Med J Aust. 2003 Mar 17;178(6):290-5. doi: 10.5694/j.1326-5377.2003.tb05199.x.

Reference Type: BACKGROUND

PMID: 12633489 (View on PubMed)

Madigan NK, DeLuca J, Diamond BJ, Tramontano G, Averill A. Speed of information processing in traumatic brain injury: modality-specific factors. J Head Trauma Rehabil. 2000 Jun;15(3):943-56. doi: 10.1097/00001199-200006000-00007.

Reference Type: BACKGROUND

PMID: 10785624 (View on PubMed)

Marsh NV, Ludbrook MR, Gaffaney LC. Cognitive functioning following traumatic brain injury: A five-year follow-up. NeuroRehabilitation. 2016;38(1):71-8. doi: 10.3233/NRE-151297.

Reference Type: BACKGROUND

PMID: 26889800 (View on PubMed)

Morton MV, Wehman P. Psychosocial and emotional sequelae of individuals with traumatic brain injury: a literature review and recommendations. Brain Inj. 1995 Jan;9(1):81-92. doi: 10.3109/02699059509004574.

Reference Type: BACKGROUND

PMID: 7874099 (View on PubMed)

Navarro-Main B, Castano-Leon AM, Munarriz PM, Gomez PA, Rios-Lago M, Lagares A. [Brain injury knowledge in family members of neurosurgical patients]. Neurocirugia (Engl Ed). 2018 Jan-Feb;29(1):1-8. doi: 10.1016/j.neucir.2017.09.007. Epub 2017 Nov 8. Spanish.

Reference Type: BACKGROUND

PMID: 29128284 (View on PubMed)

Palmese CA, Raskin SA. The rehabilitation of attention in individuals with mild traumatic brain injury, using the APT-II programme. Brain Inj. 2000 Jun;14(6):535-48. doi: 10.1080/026990500120448.

Reference Type: BACKGROUND

PMID: 10887887 (View on PubMed)

Parasuraman R, Mutter SA, Molloy R. Sustained attention following mild closed-head injury. J Clin Exp Neuropsychol. 1991 Sep;13(5):789-811. doi: 10.1080/01688639108401090.

Reference Type: BACKGROUND

PMID: 1955532 (View on PubMed)

Quedaza, M. (2011). Acquired Brain Damage (DCA) in Spain: main results from the AGE-2008 Survey. Bulletin of the State Disability Observatory, 3, 39-59.

Reference Type: BACKGROUND

Rios-Lago M, Munoz-Cespedes JM, Paul-Lapedriza N. [Attentional impairment after traumatic brain injury: assessment and rehabilitation]. Rev Neurol. 2007 Mar 1-15;44(5):291-7. Spanish.

Reference Type: BACKGROUND

PMID: 17342680 (View on PubMed)

Sander AM, Seel RT, Kreutzer JS, Hall KM, High WM Jr, Rosenthal M. Agreement between persons with traumatic brain injury and their relatives regarding psychosocial outcome using the Community Integration Questionnaire. Arch Phys Med Rehabil. 1997 Apr;78(4):353-7. doi: 10.1016/s0003-9993(97)90225-2.

Reference Type: BACKGROUND

PMID: 9111453 (View on PubMed)

Sohlberg, M. M, Johnson, L., Paule, L., Raskin, S. A., & Mateer, C. A. (2001). Attention process training-II: A program to address attentional deficits for persons with mild cognitive dysfunction (2nd ed.). Wake Forest: NC: Lash & Associates

Reference Type: BACKGROUND

Sohlberg MM, Mateer CA. Effectiveness of an attention-training program. J Clin Exp Neuropsychol. 1987 Apr;9(2):117-30. doi: 10.1080/01688638708405352.

Reference Type: BACKGROUND

PMID: 3558744 (View on PubMed)

Sohlberg MM, McLaughlin KA, Pavese A, Heidrich A, Posner MI. Evaluation of attention process training and brain injury education in persons with acquired brain injury. J Clin Exp Neuropsychol. 2000 Oct;22(5):656-76. doi: 10.1076/1380-3395(200010)22:5;1-9;FT656.

Reference Type: BACKGROUND

PMID: 11094401 (View on PubMed)

Varas-Arias MT, Rodriguez-Palero S. [Rehabilitation treatment in child and youth patients with acquired brain injury]. Rev Neurol. 2017 May 17;64(s03):S1-S7. Spanish.

Reference Type: BACKGROUND

PMID: 28524211 (View on PubMed)

Wassenberg R, Max JE, Lindgren SD, Schatz A. Sustained attention in children and adolescents after traumatic brain injury: relation to severity of injury, adaptive functioning, ADHD and social background. Brain Inj. 2004 Aug;18(8):751-64. doi: 10.1080/02699050410001671775.

Reference Type: BACKGROUND

PMID: 15204316 (View on PubMed)

Whyte J, Hart T, Ellis CA, Chervoneva I. The Moss Attention Rating Scale for traumatic brain injury: further explorations of reliability and sensitivity to change. Arch Phys Med Rehabil. 2008 May;89(5):966-73. doi: 10.1016/j.apmr.2007.12.031.

Reference Type: BACKGROUND

PMID: 18452747 (View on PubMed)

Wilson, B. A. (2013). Neuropsychological rehabilitation: State of the science. South African Journal of Psychology, 43(3), 267-277.

Reference Type: BACKGROUND

Yeates KO, Armstrong K, Janusz J, Taylor HG, Wade S, Stancin T, Drotar D. Long-term attention problems in children with traumatic brain injury. J Am Acad Child Adolesc Psychiatry. 2005 Jun;44(6):574-84. doi: 10.1097/01.chi.0000159947.50523.64.

Reference Type: BACKGROUND

PMID: 15908840 (View on PubMed)

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Other Identifiers

001b

Identifier Type: -

Identifier Source: org_study_id