Evaluation of the Karman Line Memory Strategy Training

NCT ID: NCT06774287

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2026-05-15

Brief Summary

Rationale: Acquired brain injury (ABI) often results in memory deficits that can have a big impact on social and vocational functioning of patients. Rehabilitation treatment of memory dysfunction consists of optimizing memory performance by using effective compensation strategies. Several effective memory-strategy training programs have been developed. However, these often contain labor-intensive treatment protocols that are possibly an overtreatment of ABI patients with relatively mild memory impairments. On the other hand there is a sprawl of commercial computerized cognitive training programs or 'brain games' available that claim to restore memory function. However, research has repeatedly shown that treatment effects of available brain games do not generalize to daily life functioning. With the shortcomings of current memory treatment programs in mind, the investigators developed a combined computerized and face-to-face training of memory strategies, which consists of a shortened traditional face-to-face treatment combined with an innovative Brain Game based on compensation strategies instead of restorative training. This is a promising cost-effective intervention that provides the possibility of repeated practice at home to train compensatory strategies in a safe and imaginative digital environment. The hypothesis is the strategy training will promote generalization, also after rehabilitation ends.

Objective: The primary objective is the evaluation of the potential positive effect of the combined computerized and face-to-face memory treatment on effective memory strategy use and reducing subjective memory failures in ABI patients with memory deficits in the chronic phase of acquired brain injury (>3 months after injury).

Study design: The study will be a multiple-baseline across individuals single-case experimental design (SCED). Three patients will receive treatment as usual and three patients will receive a shortened treatment combined with the game, which will be referred to as the 'Karman Line memory strategy training'.

Study population: The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have memory deficits and complaints 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. Memory deficits will be assessed by neuropsychological examination, memory complaints will be assessed by the Everyday Memory Questionnaire-Revised (EMQ-R). In one year six to eight participants will be recruited.

Intervention: The Karman Line memory strategy training consists of six weekly treatment sessions under the guidance of a therapist. The protocol is a shortened version of an existing memory strategy training (treatment as usual), which contains ten sessions. In the sessions, patients get information about memory and memory strategies and learn to apply those to their personal treatment goals. Inbetween the sessions, the participant will work on personal memory goals and practice the strategies by playing the corresponding levels of the memory game at home.

Main study parameters/endpoints: The main study parameter is the three most commonly reported memory complaints selected from the 13-item scale of the EMQ-R. The primary outcome measure is not the EMQ-R, but a personalized set of measurement VAS-scales for each patient. Secondary study parameters include the impact of memory problems on activities and participation, the achievement of personalized treatment goals, objective strategy use, objective memory functioning, metacognitions about memory and measures of feasibility by patients and practitioners.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden in the study consists of participating in repeated measurements, therapy sessions, and homework assignments. All tests and methods that are used are non-invasive and not stressful for the patient. All tests and tasks will be based on widely-used validated and reliable paper-pencil or computer tasks. Treatment is non-invasive and scarcely stressful: a therapist will always be present and assess the patient's burden and eventually take appropriate measures such as inserting a resting break.

Conditions

Acquired Brain Injury (Including Stroke)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment as usual

Treatment as usual contains 10 memory strategy sessions (two sessions per week) with a therapist in the rehabilitation centre.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Treatment as usual contains ten sessions, with nine obligatory sessions supplemented with 1 (of five) non-obligatory sessions. Which non-obligatory sessions is chosen is dependent on the patients treatment goals.

Karman Line memory training

Karman Line memory strategy training contains 6 weekly memory strategy sessions in the rehabilitation centre, combined with practicing digital games at home and using a memory app.

Group Type: EXPERIMENTAL

Karman Line memory strategy training

Intervention Type: BEHAVIORAL

The memory strategy training consists of six weekly face-to-face treatment sessions. After sessions 3-5, the participant will play 8 levels in total of the Karman Line memory game on their computer or mobile device. In these levels they practice the strategies that are introduced in the face-to-face treatment in a safe digital environment. Also, the Karman Line memory app is provided.

Interventions

Karman Line memory strategy training

The memory strategy training consists of six weekly face-to-face treatment sessions. After sessions 3-5, the participant will play 8 levels in total of the Karman Line memory game on their computer or mobile device. In these levels they practice the strategies that are introduced in the face-to-face treatment in a safe digital environment. Also, the Karman Line memory app is provided.

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual contains ten sessions, with nine obligatory sessions supplemented with 1 (of five) non-obligatory sessions. Which non-obligatory sessions is chosen is dependent on the patients treatment goals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• presence of subjective memory complaints. Memory complaints will be operationalized as ≥1 standard deviation on the total score of the EMQ-R questionnaire in comparison with the healthy control norm.
• presence of mild to moderate objective memory deficits, objectified with neuropsychological assessment for clinical purposes. Mild to moderate memory deficits will be operationalized as test score ≥1 standard deviation (SD) and <2 SD in comparison to the normative mean on at least two separate memory measures and no more than one measure ≥ 2SD. For each task the norm data that is described in the test manual will be used.
• Age: 18-75 years
• Non-progressive acquired brain injury
• Minimal time post-onset of 3 months
• Outpatient rehabilitation
• Living independently at home
• Premorbid functioning: score 4 on the Verhage scale

Exclusion Criteria

• Severe memory deficits
• Inability to speak and/or understand the Dutch language
• Severe disorders in executive functioning
• Severe psychiatric problems
• Neurodegenerative disorders
• Substance abuse
• Aphasia
• Neglect
• No access to a smartphone and a tablet/laptop with internet connection
• Unable to look at a computer screen for 15 minutes
• Unable to operate a keyboard or computer mouse.
• No informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klimmendaal Revalidatiespecialisten

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klimmendaal Revalidatiespecialisten

Arnhem, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Edo Grevers, MSc.

Role: CONTACT

e.grevers@klimmendaal.nl

+31620839323

Facility Contacts

Edo Grevers, MSc.

Role: primary

e.grevers@klimmendaal.nl

+31620839323

Other Identifiers

KNP23PROJ1

Identifier Type: -

Identifier Source: org_study_id