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Strategy Game Supporting Goal Management Training Intervention

K

Klimmendaal Revalidatiespecialisten

Status

Completed

Conditions

Neuropsychological Rehabilitation
Acquired Brain Injury
Executive Dysfunction

Treatments

Behavioral: Information Group
Behavioral: Game-Supported Goal Management Training

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT05621941
Dutch Trial Register (Registry Identifier)
Karman Line GMT

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

21 participants in 2 patient groups

Game-Supported Goal Management Training
Experimental group
Description:
Seven treatment sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist and cognitive trainer or occupational therapist.
Treatment:
Behavioral: Game-Supported Goal Management Training
Information Group
Active Comparator group
Description:
Seven information sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist.
Treatment:
Behavioral: Information Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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