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NCT05737238
A Single-case Design to Investigate a Compensatory Strategy Game Supporting Goal Management Training
Conditions: Acquired Brain Injury, Executive Dysfunction, Goal Management Training, Compensatory Strategy Training, Serious Gaming
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 4
Sponsor: Klimmendaal Revalidatiespecialisten
Summary
The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by executive function (EF) deficits.
In order to minimize the everyday disorganization, effective EF interventions are required.
Interventions which incorporate compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life.
A well-known evidence-based intervention that incorporates compensatory strategies is Goal Management Training (GMT).
GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving.
To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks.
Therefore, GMT is a comprehensive, time-consuming and thus labour-intensive treatment.
Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care.
Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e.
strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning.
This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly home-based GMT intervention.
The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task.
The study will be a multiple-baseline across individuals single-case experimental design (SCED).
The study population consists of patients referred for outpatient cognitive rehabilitation.
Participants eligible for the study must have executive deficits due to Acquired Brain Injury (ABI) of nonprogressive nature (i.e.
TBI, stroke), with a minimum time post-onset of 3 months.
Age has to be between 18 and 75 and participants have to live independently at home.
Executive deficits will be assessed by extensive neuropsychological examination.
Participants will be recruited from the outpatient clinic and the department of neurorehabilitation of Klimmendaal and Vogellanden.
Four participants will be recruited.
Eligibility Criteria
Inclusion Criteria:Age: 18 - 75 yearsNon-progressive acquired brain injuryMinimal time post-onset of 3 monthsOutpatient rehabilitationLiving independently at homeExecutive deficits (as determined on a neuropsychological assessment)Exclusion Criteria:Inability to speak/understand the Dutch languageSevere psychiatric problems (history)Neurodegenerative disordersSubstance abuseSevere cognitive comorbidity (i.e.
dementia)AphasiaNeglectNo access to a smartphone, and laptop or tabletUnable to look at a computer screen for 15 minutesUnable to operate a keyboard or computer mouse
Source: ClinicalTrials.gov (NCT05737238). StuddyBuddy aggregates publicly available trial information.