The primary objective of this pilot study is to investigate the feasibility of GMT with a new game that incorporates strategy training inimproving executive functions in a pilot sample of brain-injured patients. This study investigates the usability…
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 parameters are to explore the usability and playability of the
strategy game, and to assess the feasibility of the
shortened GMT treatment. Participants have to complete the system usability
scale (SUS) questionnaire at the end of treatment.
Furthermore, interviews with participants will be carried out to validate the
findings from the survey and to gather participants*
experience of using the game, the playability and factors that may affect their
treatment outcome. In addition, a questionnaire survey
to investigate therapists* acceptance and intention to use the treatment for
acquired brain injury cognitive rehabilitation will be
conducted in order to assess the feasibility.
Secondary outcome
Secondary study parameters are a standardized scale measuring performance of
four different untrained IADL tasks (two tasks at
baseline, two other tasks post-treatment). Also, the achievement of goals set
(GAS), participation (USER-P), insight and reported
severity of executive problems (BRIEF-A), a neuropsychological assessment
regarding executive functioning, and the subjective
experience of strategy use in daily life and during the performance of IADL
tasks.
Background summary
These difficulties can be characterized as executive deficits, which can vary
from relatively mild to rather severe. Executive deficits
lead to real-life everyday disorganization and difficulties in instrumental
activities of daily living (IADL tasks). Goal Management
Training (GMT) is a successful treatment for executive deficits and helps to
structure activities in daily life. 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. Patients are taught compensatory strategies not to strengthen the
executive functions, but to enable them to minimize
disabilities and participation problems and to function more independently in
daily life. The currently implemented GMT treatment in
the Netherlands is aimed at relearning two specific tasks. However, to adopt
the GMT strategy and ensure maximal profitability for
patients, they have to learn to use the algorithm in different situations and
tasks, which requires 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, and because of
their machine learning algorithms which tailors the
game to the level of the individual player. 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 no transfer
to improvements in daily life functioning. The present study fills a gap in the
literature by investigating a new developed treatment
that incorporates GMT and a treatment supporting strategy game in a pilot
sample of brain injured patients.
Study objective
The primary objective of this pilot study is to investigate the feasibility of
GMT with a new game that incorporates strategy training in
improving executive functions in a pilot sample of brain-injured patients. This
study investigates the usability and acceptability of our
new developed GMT treatment to brain-injured patients in the chronic phase (>3
months post-onset), and obtains an efficacy
estimate, focusing on transfer of treatment effects to untrained (instrumental)
activities of daily living.
Study design
Brain-injured patients will be randomized into the strategy game supported GMT
treatment and an information group. Both
treatments consist of a 7-week training comprising 7 one-hour sessions.
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 a shortened version of
GMT in combination with a compensatory strategy 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 the 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. In the information
group, education and information is provided about various non-specific
consequences of acquired brain injury. Both the
investigational GMT treatment and information group will last 7 weeks.
Study burden and risks
The burden in the study consists of participating in two repeated measurements,
therapy sessions, and homework assignments. All
brain-injured patients who receive a treatment program at the Klimmendaal
Rehabilitation Center start with the information group.
For this reason, we decided to include the information group as our active
control condition to reduce the burden of patients in
obtaining our secondary study objective. All tests and methods that are used
are non-invasive and not stressful for the patient. All
tests and tasks will be widely-used validated and reliable paper-pencil or
computerized tasks. The participant can work in his/her
own pace, and if desired additional breaks will be taken. Treatment is
non-invasive and scarcely stressful: a therapist will always be
present and assess the patient*s burden and eventually take appropriate
measures such as inserting a resting break. Participants
assigned to both the GMT group and the information group will have seven 1-hour
sessions.
Heijenoordseweg 5
Arnhem 6813 GG
NL
Heijenoordseweg 5
Arnhem 6813 GG
NL
Listed location countries
Age
Inclusion criteria
Age: 18-70
Non-progressive acquired brain injury
Minimal time post-onset of 3 months
Outpatient rehabilitation
Living independently at home
Executive problems evidenced by a clinically meaningful (increased) score on
the BRIEF-A
Exclusion criteria
Inability to speak/understand the Dutch language
Severe psychiatric problems (history)
Neurodegenerative disorders
Substance abuse
Severe 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL74855.091.20 |
| OMON | NL-OMON26575 |