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…
ID
Source
Brief title
Condition
- Other condition
- Structural brain disorders
Synonym
Health condition
niet-aangeboren hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the OxMET-NL, a computer-tablet based version of
the Multiple Errands Test. The task requires patients to buy six items and to
answer two questions. Participants are allowed to complete the tasks in any
order. Participants perform different parallel versions of the OxMET-NL twice a
week during the baseline and intervention phase (see study design for more
details).
Secondary outcome
The secondary study parameters are the performance on two trained IADL tasks,
goal achievement (GAS), and subjective strategy use (VAS).
Background 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.
Study objective
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.
Study design
The study will be a multiple-baseline across individuals single-case
experimental design (SCED).
Intervention
The investigational treatment is based on the standard GMT treatment, part of
the cognitive rehabilitation intervention at Klimmendaal that is used for ABI
patients with executive problems. The investigational treatment will include
GMT in combination with a compensatory brain game which allows the patient to
learn and apply the algorithm of GMT in a safe and controlled environment. This
means that the multiple steps of GMT will be learned during the treatment
sessions under guidance of a therapist as well as in their own home environment
by using the compensatory strategy game. The investigational GMT treatment will
consist of 6 treatment sessions given twice a week (with a total duration of 3
weeks).
Study burden and risks
The burden in the study consists of participating in repeated measurements,
therapy sessions, and homework assignments. All tests and methods that are used
are non-invasive and not stressful for the patient. All tests and tasks will be
based on widely-used validated and reliable paper-pencil or computer tasks.
Treatment is non-invasive and scarcely stressful: a therapist will always be
present and assess the patients burden and eventually take appropriate measures
such as inserting a resting break.
Heijenoordseweg 5
Arnhem 6813 GG
NL
Heijenoordseweg 5
Arnhem 6813 GG
NL
Listed location countries
Age
Inclusion criteria
Age: 18-75 jaar
Non-progressive acquired brain injury
Minimal time post-injury 3 months
Outpatient rehabilitation
Living independently at home
Executive disorder evidenced by a neuropsychological assessment
Exclusion criteria
Inability to speak/ understand the Dutch language
Severe psychiatric problems (history)
Neurodegenerative disorders
Substnace abuse
Several cognitive comorbidity (i.e. dementia)
Aphasia
Neglect
No access to a smartphone, and laptop or tablet
Unable to look at a computer screen for 15 minutes a day
Unable to operate a keyboard and/or computer mouse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL81342.091.22 |