Evaluation of the Karman Line Memory Strategy Training

NCT06774287 | Recruiting

• 1 other identifier: KNP23PROJ1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Keywords

Compensatory brain games; Acquired Brain Injury; memory disorder

Outcome Measures

Primary Outcomes (1)

• memory complaints

  The 13-item scale of the everyday memory questionnaire-revised (EMQ-R) is used to select the three most common memory complaints that are targeted with the intervention. The primary outcome measure is not the EMQ-R, but a personalized set of measurement visual analogue scales (VAS) for each patient. The total score (range 0-30) will be used as outcome measure. A higher score indicates more memory complaints, which is a worse outcome.

  every other day during 8-10 weeks, weekly during 3-5 weeks

Secondary Outcomes (16)

• The impact of memory problems on activities and participation

  every other day during 8-10 weeks, weekly during 3-5 weeks

• The achievement of personalized treatment goals

  4 measurements during study participation (during 13 weeks)

• Objective strategy use task

  4 measurements during study participation (during 13 weeks)

• Rivermead Behavioural Memory Test-3 (RBMT-3-NL)

  2 measurements during study participation (during 13 weeks)

• Location Learning Test (LLT)

  2 measurements during study participation (during 13 weeks)

Study Arms (2)

treatment as usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Karman Line memory training

EXPERIMENTAL

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.

Behavioral: Karman Line memory strategy training

Interventions

Karman Line memory strategy training 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.

Karman Line memory training

Treatment as usual 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.

treatment as usual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klimmendaal Revalidatiespecialisten: lead

Study Sites (1)

Klimmendaal Revalidatiespecialisten

Arnhem, Gelderland, 6813 GG, Netherlands

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Memory Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edo Grevers, MSc.

CONTACT

+31620839323; e.grevers@klimmendaal.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: January 14, 2025
• Study Start: January 21, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

NL (1)