Acquired Brain InjuryNCT05737238
A Single-case Design to Investigate a Compensatory Strategy Game Supporting Goal Management Training
A study testing Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention in people with Acquired Brain Injury and Executive Dysfunction, run by Klimmendaal Revalidatiespecialisten at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injury, Executive Dysfunction, Goal Management Training
- What is being tested?
- Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Apr 2023to 1 Feb 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 75 years
- Non-progressive acquired brain injury
- Minimal time post-onset of 3 months
- Outpatient rehabilitation
- Living independently at home
- Executive deficits (as determined on a neuropsychological assessment)
Who cannot join
- Inability to speak/understand the Dutch language
- Severe psychiatric problems (history)
- Neurodegenerative disorders
- Substance abuse
- Severe cognitive comorbidity (i.e. dementia)
- Aphasia
Show all 10Show fewer
- Neglect
- No access to a smartphone, and laptop or tablet
- Unable to look at a computer screen for 15 minutes
- Unable to operate a keyboard or computer mouse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Klimmendaal Revalidatiespecialisten
Arnhem, Gelderland, 6813 GG
Dirk Bertens, PhD, 026 352 6100, d.bertens@klimmendaal.nl
Elise Verhoog, MSc.
About this study
Official title: Evaluation of a Compensatory Brain Game Supporting Goal Management Training Targeting Executive Function After Acquired Brain Injury Using Single-case Experimental Design Methodology
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.
- Conditions
- Acquired Brain Injury, Executive Dysfunction, Goal Management Training, Compensatory Strategy Training, Serious Gaming
- Being tested
- Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention during phase B: Compensatory brain game supporting Goal Management Training interventionBehavioural
The investigational treatment is only given during the intervention phase (phase B), and consists of six treatment sessions. In the treatment sessions, patients learn and apply the GMT algorithm. This means that the multiple steps of the GMT as well as the actual performance of the IADL-task goals will be learned under guidance of a therapist. In order to facilitate generalization, patients will learn to use the algorithm during the performance of untrained tasks by playing the treatment supporting Plan Game. Because of this, patients are able to practice the application of the GMT algorithm independently at their own home. Besides, the intervention also includes a Plan Tool. This is a mobile application that can be used as an aid during the performance of (instrumental) activities of daily living (IADL) tasks in order to perform activities more independently. The GMT treatment sessions are given twice a week (max. 60 minutes for each attendance).
| Study group | Role | What they receive |
|---|---|---|
| Baseline phase (Phase A) | No intervention | At the start of the study, all participants are assigned to the baseline phase (phase A). During phase A, patients do not receive interventions related to executive function problems. The start of the intervention phase (phase B) is determined randomly for each participant, given the restriction that phase A should last for at least three weeks (21 days) and at most five weeks (30 days). This means that phase B can start on any day between the 21th and the 30th days, resulting in a total of 10 possible assignments. So, in the first three weeks, all participants are in phase A. The duration of phase A will thus be different for each subject. Phase A acts as a control and is therefore compared with phase B. |
| Intervention phase (Phase B): Goal Management Training | Experimental | During the intervention phase (phase B), all included participants will have 6 sessions of Goal Management Training (GMT; twice per week) in which two individual chosen IADL-tasks will be subdivided into multiple steps under guidance of a therapist using the GMT method. In addition participants play the compensatory brain game in which they are challenged to apply the learned GMT strategy in an imaginary and safe environment. Receives: Behavioral: Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention |
| Follow-up period | No intervention | A follow-up period of three weeks takes place after phase B. During this follow-up period, patients receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
The target behavior will be assessed repeatedly, on a minimum of six occasions in phase A and B, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). The OxMET-NL task is a computer-tablet based version of the Multiple Errands Test and is scored automatically. The task requires patients to buy six items and to answer two questions.
Measured: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (3 weeks)
Secondary outcomes (6)
Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up
Subjective experience of strategy use in daily life and during the performance of instrumental activities of daily living (IADL).
Measured: The VAS will be assessed repeatedly, two times a week, for the duration of phase A (3 to 5 weeks), phase B (3 weeks) and follow-up (3 weeks)
Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)
GAS is a mathematical technique for quantifying the achievement of goals set, used in rehabilitation. GAS is described as a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has a own outcome measure, but this is scored in a standardized way as to allow statistical analysis. The achievement of each goal (IADL-task) can be measured on a 5-point scale ranging from -2 to +2. Outcomes can be quantified in a single aggregated goal attainment score. This method gives a numerical T-score which is normally distributed about a mean of 50 (if the goals are achieved precisely) with a standard deviation of around this mean of 10 (if the goals are overachieved or underachieved).
Measured: pre-intervention, immediately following intervention and at three weeks follow-up
Change in performance on two trained IADL task (treatment goals)
Performance on two treatment goals is measured with a standardised scale which is similar to the one used by Bertens et al. (2015) and Dechamps et al. (2011). The tasks will be divided into multiple steps using the GMT method. Each task step will be assessed following a 3-point scale (ranging from 2=competent to 0=deficit). Total scores per task will be adjusted to a 100-point scale using the following formula: performance = (total score / (number of steps × 2)) × 100. Thus, a performance of 100% indicating perfect IADL task performance.
Measured: pre-intervention, immediately following intervention and at three weeks follow-up
Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)
The Dutch version of the Daily Living Questionnaire measures how much mental or cognitive difficulty the participant generally has by performing daily activities.
Measured: pre-intervention, immediately following intervention and at three weeks follow-up
Change in strategy use during the performance of trained and untrained IADL tasks
A self-designed questionnaire to examine self-reported strategy use will also be administered after the performance of the trained and untrained IADL tasks, based on the strategy questionnaire used by Frankenmolen, Fasotti, Kessels \& Oosterman (2018), in order to measure strategy use in a traditional memory task. First, participants are openly asked which strategies they use during the performance of an IADL task. Subsequently, they are given a list with possible strategy components of GMT that one could use to perform a task and are asked to place a check mark next to each strategy that they had used.
Measured: pre-intervention, immediately following intervention and at three weeks follow-up
Change in subjective experience of strategy use in daily life
GMT strategy use is assessed through an adjustment of the Strategy Use Inventory; SUI (Koning-Haanstra, Berg, \& Deelman, 1990). Participants have to indicate how often they use a certain strategy in daily life situations using a 5-point rating scale ranging from 1 (never) to 5 (often). Average item scores are calculated.
Measured: pre-intervention, immediately following intervention and at three weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Apr 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
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
- Crossover
- Model description
- A randomized Single-case Experimental Design (SCED) with a follow-up period of 1 month. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure. Phase A acts as a control and is therefore compared with phase B.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klimmendaal Revalidatiespecialisten
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Elise Verhoog, MSc, Principal investigator, Donders Centre for Cognitive Neuroimaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737238
- Sponsor's protocol ID
- Karman Line GMT SCED
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 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
- Evaluation of a Compensatory Brain Game Supporting Goal Management Training Targeting Executive Function After Acquired Brain Injury Using Single-case Experimental Design Methodology
- ClinicalTrials.gov ID
- NCT05737238
- Acronym / sponsor ID
- Karman Line GMT SCED
- Conditions
- Acquired Brain Injury, Executive Dysfunction, Goal Management Training, Compensatory Strategy Training, Serious Gaming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Klimmendaal RevalidatiespecialistenResearch network
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Feb 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized Single-case Experimental Design (SCED) with a follow-up period of 1 month. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure. Phase A acts as a control and is therefore compared with phase B.
| Arm | Type | Receives |
|---|---|---|
| Baseline phase (Phase A) | No intervention | –At the start of the study, all participants are assigned to the baseline phase (phase A). During phase A, patients do not receive interventions related to executive function problems. The start of the intervention phase (phase B) is determined randomly for each participant, given the restriction that phase A should last for at least three weeks (21 days) and at most five weeks (30 days). This means that phase B can start on any day between the 21th and the 30th days, resulting in a total of 10 possible assignments. So, in the first three weeks, all participants are in phase A. The duration of phase A will thus be different for each subject. Phase A acts as a control and is therefore compared with phase B. |
| Intervention phase (Phase B): Goal Management Training | Experimental | Behavioral: Intervention during phase B: Compensatory brain game supporting Goal Management Training interventionDuring the intervention phase (phase B), all included participants will have 6 sessions of Goal Management Training (GMT; twice per week) in which two individual chosen IADL-tasks will be subdivided into multiple steps under guidance of a therapist using the GMT method. In addition participants play the compensatory brain game in which they are challenged to apply the learned GMT strategy in an imaginary and safe environment. |
| Follow-up period | No intervention | –A follow-up period of three weeks takes place after phase B. During this follow-up period, patients receive no intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 - 75 years
- Non-progressive acquired brain injury
- Minimal time post-onset of 3 months
- Outpatient rehabilitation
- Living independently at home
Key exclusion criteria (10 listed)
- Inability to speak/understand the Dutch language
- Severe psychiatric problems (history)
- Neurodegenerative disorders
- Substance abuse
- Severe cognitive comorbidity (i.e. dementia)
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 |
|---|---|---|
| Intervention during phase B: Compensatory brain game supporting Goal Management Training interventionThe investigational treatment is only given during the intervention phase (phase B), and consists of six treatment sessions. In the treatment sessions, patients learn and apply the GMT algorithm. This means that the multiple steps of the GMT as well as the actual performance of the IADL-task goals will be learned under guidance of a therapist. In order to facilitate generalization, patients will learn to use the algorithm during the performance of untrained tasks by playing the treatment supporting Plan Game. Because of this, patients are able to practice the application of the GMT algorithm independently at their own home. Besides, the intervention also includes a Plan Tool. This is a mobile application that can be used as an aid during the performance of (instrumental) activities of daily living (IADL) tasks in order to perform activities more independently. The GMT treatment sessions are given twice a week (max. 60 minutes for each attendance). | Behavioural | Intervention phase (Phase B): Goal Management Training |
Primary outcome
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
Time frame: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (3 weeks)
The target behavior will be assessed repeatedly, on a minimum of six occasions in phase A and B, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). The OxMET-NL task is a computer-tablet based version of the Multiple Errands Test and is scored automatically. The task requires patients to buy six items and to answer two questions.
6 secondary outcomes
Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up
Time frame: The VAS will be assessed repeatedly, two times a week, for the duration of phase A (3 to 5 weeks), phase B (3 weeks) and follow-up (3 weeks)
Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)
Time frame: pre-intervention, immediately following intervention and at three weeks follow-up
Change in performance on two trained IADL task (treatment goals)
Time frame: pre-intervention, immediately following intervention and at three weeks follow-up
Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)
Time frame: pre-intervention, immediately following intervention and at three weeks follow-up
Change in strategy use during the performance of trained and untrained IADL tasks
Time frame: pre-intervention, immediately following intervention and at three weeks follow-up
Change in subjective experience of strategy use in daily life
Time frame: pre-intervention, immediately following intervention and at three weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- 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.
Elise Verhoog, MSc principal investigator
Donders Centre for Cognitive Neuroimaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention 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 6 inclusion and 10 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Bertens, Dr (0263526100, d.bertens@klimmendaal.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B (time frame: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (3 weeks)). 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.