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

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 - Pilot GMT Karman Line

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52362

Enrollment

Registered

2020-10-27

Start date

2022-05-02

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Niet-aangeboren hersenletsel Acquired brain injury brain damage

Interventions

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 inve

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)