Acquired Brain InjuryNCT05621941
Strategy Game Supporting Goal Management Training Intervention
A study testing Game-Supported Goal Management Training and Information Group in people with Acquired Brain Injury and Executive Dysfunction, run by Klimmendaal Revalidatiespecialisten at 1 site in Netherlands.
Trial summary
Many brain-injured patients referred for outpatient rehabilitation have difficulties with planning, problems solving, and reasoning. These difficulties can be characterized as executive deficits, which can vary from relatively mild to rather severe. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Brain Injury, Executive Dysfunction, Neuropsychological Rehabilitation
- What is being tested?
- Game-Supported Goal Management Training and Information Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2022to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any type of acquired brain injury of non-progressive nature in the past, being more than three months post injury.
- A Clinically meaningful score of executive complaints on the BRIEF-A.
- Aged between 18 and 70 years
- Referred for outpatient rehabilitation
- Living independently at home
Who cannot join
- Inability to speak/ understand the Dutch language
- Co-morbidity that might affect outcome (e.g. neurodegenerative disorders, aphasia, neglect, and major psychiatric illness)
- Substance abuse
- No access to a smartphone, laptop or tablet
- Unable to look at a computer screen for 15 minutes
- Being unable to operate a keyboard or computer mouse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Klimmendaal Revalidatiespecialisten
Arnhem, Gelderland, 6813 GG
About this study
Official title: A Strategy Game Supporting Goal Management Training Intervention for the Treatment of Executive Problems After Acquired Brain Injury: a Randomized Controlled Pilot Study for Usability and Preliminary Efficacy
Many brain-injured patients referred for outpatient rehabilitation have difficulties with planning, problems solving, and reasoning. 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. The primary objective of this pilot study is to obtain an efficacy estimate and 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 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. Chronic brain-injured patients will be allocated to the game-supported GMT treatment or to an information group using block randomization. It will be an assessor blind study in which researchers responsible for assessing or analyzing data will be blind for the received treatment.
- Being tested
- Game-Supported Goal Management Training, Information Group
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Supported Goal Management TrainingBehavioural
The investigational treatment is based on a compensatory strategy training named Goal Management Training (GMT). The investigational treatment will include 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.
Information GroupBehavioural
In the information group, patients are informed about non-specific consequences of acquired brain injury, aimed to increase patient's insight into their condition and with that improving functioning. The program consists of the following subjects: 1) cause of brain injury, 2) information processing and attention, 3) memory, 4) planning and performance, 5) fatigue, 6) changes in emotion and behavior and 7) processing and adjustments.
| Study group | Role | What they receive |
|---|---|---|
| Game-Supported Goal Management Training | Experimental | Seven treatment sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist and cognitive trainer or occupational therapist. Receives: Behavioral: Game-Supported Goal Management Training |
| Information Group | Active comparator | Seven information sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist. Receives: Behavioral: Information Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline performance on untrained IADL tasks immediately after the intervention
Standardized scale measuring performance of an untrained IADL task (int. al. the percent change in the number of correct steps) before (baseline) and after treatment (post treatment). The untrained IADL tasks will be divided into multiple steps using the GMT method. These steps will be assessed using four categories: 1) additional/unrelated; 2) absent/incomplete; 3) questionable/ineffective; 4) competent/correct, using task-specific assessment forms.
Measured: Baseline and immediately after the intervention
Secondary outcomes (12)
Change from baseline Goal Attainment Scaling (GAS) on untrained task performance immediately after the intervention
Quantifying the subjective improvement on untrained task performance
Measured: Baseline and immediately after the intervention
Change from baseline subjective strategy use immediately after the intervention
The subjective experience of strategy use in daily life and during the performance of IADL tasks, as measured by two short self-reported questionnaires.
Measured: Baseline and immediately after the intervention
Change from baseline participation as measured by the USER-P immediately after the intervention
"Utrecht Scale for Evaluation of Rehabilitation - Participation" (USER-P)
Measured: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the Zoo map test immediately after the intervention
Zoo map test
Measured: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the modified six elements test immediately after the intervention
Modified six elements test
Measured: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the Brixton immediately after the intervention
Brixton
Measured: Baseline and immediately after the intervention
Change from baseline subjective cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ) immediately after the intervention
Cognitive Failure Questionnaire (CFQ)
Measured: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the OxMET-NL immediately after the intervention
Oxford Multiple Errands Test - Dutch version (OxMET-NL)
Measured: Baseline and immediately after the intervention
Change from baseline subjective executive complaints immediately after the intervention
Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)
Measured: Baseline and immediately after the intervention
Change from baseline Goal Attainment Scaling (GAS) on treatment goals immediately after the intervention
Quantifying the achievement of treatment goals, only measured in the game-supported GMT group.
Measured: Baseline and immediately after the intervention
System Usability Scale (SUS) questionnaire
To evaluate the usability of the game-supported GMT treatment.
Measured: Immediately after the intervention
Technological Acceptance Model (TAM) questionnaire
To evaluate the user-acceptance of the game-supported GMT treatment.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 May 2022
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klimmendaal Revalidatiespecialisten
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621941
- Sponsor's protocol ID
- Karman Line GMT
- Other IDs
- Dutch Trial Register
- Status last verified
- Jun 2023
- First submitted
- 4 Nov 2022
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Strategy Game Supporting Goal Management Training Intervention for the Treatment of Executive Problems After Acquired Brain Injury: a Randomized Controlled Pilot Study for Usability and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT05621941
- Acronym / sponsor ID
- Karman Line GMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Klimmendaal RevalidatiespecialistenResearch network
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many brain-injured patients referred for outpatient rehabilitation have difficulties with planning, problems solving, and reasoning. 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. The primary objective of this pilot study is to obtain an efficacy estimate and 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 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. Chronic brain-injured patients will be allocated to the game-supported GMT treatment or to an information group using block randomization. It will be an assessor blind study in which researchers responsible for assessing or analyzing data will be blind for the received treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game-Supported Goal Management Training | Experimental | Behavioral: Game-Supported Goal Management TrainingSeven treatment sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist and cognitive trainer or occupational therapist. |
| Information Group | Active comparator | Behavioral: Information GroupSeven information sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any type of acquired brain injury of non-progressive nature in the past, being more than three months post injury.
- A Clinically meaningful score of executive complaints on the BRIEF-A.
- Aged between 18 and 70 years
- Referred for outpatient rehabilitation
- Living independently at home
Key exclusion criteria (6 listed)
- Inability to speak/ understand the Dutch language
- Co-morbidity that might affect outcome (e.g. neurodegenerative disorders, aphasia, neglect, and major psychiatric illness)
- Substance abuse
- No access to a smartphone, laptop or tablet
- Unable to look at a computer screen for 15 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game-Supported Goal Management TrainingThe investigational treatment is based on a compensatory strategy training named Goal Management Training (GMT). The investigational treatment will include 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. | Behavioural | Game-Supported Goal Management Training |
| Information GroupIn the information group, patients are informed about non-specific consequences of acquired brain injury, aimed to increase patient's insight into their condition and with that improving functioning. The program consists of the following subjects: 1) cause of brain injury, 2) information processing and attention, 3) memory, 4) planning and performance, 5) fatigue, 6) changes in emotion and behavior and 7) processing and adjustments. | Behavioural | Information Group |
Primary outcome
Change from baseline performance on untrained IADL tasks immediately after the intervention
Time frame: Baseline and immediately after the intervention
Standardized scale measuring performance of an untrained IADL task (int. al. the percent change in the number of correct steps) before (baseline) and after treatment (post treatment). The untrained IADL tasks will be divided into multiple steps using the GMT method. These steps will be assessed using four categories: 1) additional/unrelated; 2) absent/incomplete; 3) questionable/ineffective; 4) competent/correct, using task-specific assessment forms.
12 secondary outcomes
Change from baseline Goal Attainment Scaling (GAS) on untrained task performance immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline subjective strategy use immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline participation as measured by the USER-P immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the Zoo map test immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the modified six elements test immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the Brixton immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline subjective cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ) immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline executive functioning as measured with the OxMET-NL immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline subjective executive complaints immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline Goal Attainment Scaling (GAS) on treatment goals immediately after the intervention
Time frame: Baseline and immediately after the intervention
System Usability Scale (SUS) questionnaire
Time frame: Immediately after the intervention
Technological Acceptance Model (TAM) questionnaire
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-Supported Goal Management Training and Information Group in people with Acquired Brain Injury and Executive Dysfunction, run by Klimmendaal Revalidatiespecialisten at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline performance on untrained IADL tasks immediately after the intervention (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.