NCT05737238

A Single-case Design to Investigate a Compensatory Strategy Game Supporting Goal Management Training

Status unknown NA Last updated 29 June 2023

What this trial tests

NA trial testing Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention in Acquired Brain Injury in 4 participants. Status unknown.

Timeline

7 April 2023

Primary endpoint
1 February 2024

1 February 2024

Quick facts

Lead sponsor	Klimmendaal Revalidatiespecialisten
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	4
Start date	7 April 2023
Primary completion	1 February 2024
Estimated completion	1 February 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention

Conditions studied

• Acquired Brain Injury — all drugs for Acquired Brain Injury →
• Executive Dysfunction — all drugs for Executive Dysfunction →
• Goal Management Training — all drugs for Goal Management Training →
• Compensatory Strategy Training — all drugs for Compensatory Strategy Training →

Sponsor

Klimmendaal Revalidatiespecialisten

Who can join

Adults 18 to 75, any sex, with Acquired Brain Injury or Executive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.