Acquired Brain Injury (Including Stroke)CoRe@HomeNCT06749197
Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With ABI
A study testing Rehacom in people with Acquired Brain Injury (Including Stroke), run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Patients with acquired brain injury (ABI) may suffer from persistent cognitive deficits and/or subjective cognitive complaints, especially in the domains of attention and working memory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- What is being tested?
- Rehacom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with acquired brain injury
- receiving outpatient rehabilitation
- sufficient command of Dutch or English language
- internet access
Who cannot join
- incapacitated patients like patients diagnosed with dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Rijndam Rehabilitation
Rotterdam, South Holland, 3015LJ
Majanka H Heijenbrok-Kal, PhD, +31628129140, m.heijenbrok@erasmusmc.nl
About this study
Official title: Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With Acquired Brain Injury
Rationale: Patients with acquired brain injury (ABI) may suffer from persistent cognitive deficits and/or subjective cognitive complaints, especially in the domains of attention and working memory. Cognitive deficits are associated with anxiety and depression and may affect social participation and health-related quality of life (HR-QoL). Approximately 25% of the patients with ABI will be referred to an in- and/or outpatient rehabilitation center for multidisciplinary therapy to optimize recovery. Multiple studies suggest that supervised computerized cognitive training (CCT) may enhance cognitive functioning in patients with ABI. Recently, the CCT program RehaCom was introduced as an online version which is suitable for home training. In this study the feasibility and outcomes of implementing home-based CCT into a blended care pathway will be investigated in patients receiving outpatient rehabilitation therapy after ABI.
Objective: The aim of this study is to assess the feasibility and to evaluate the effect of blending a home-based CCT program (RehaCom) in standard care on cognitive functioning in patients after ABI.
Read more
The secondary aim is to evaluate the effect of this CCT program on subjective cognitive complaints, self-efficacy, psychological outcome measures and HR-QoL.
Study design: Randomized cross-over trial comparing a 5-week blended care pathway to 5 weeks of standard care within 30 patients with ABI.
Study population: Adults with ABI receiving outpatient rehabilitation therapy.
Intervention: A blended care pathway including 1 cognitive strategy training session of 1 hour per week in the outpatient rehabilitation center in combination with home-based CCT in 4 sessions of 30 minutes per week, during 5 weeks. The standard care pathway includes 2 cognitive training sessions of 1 hour per week in the outpatient rehabilitation center during 5 weeks.
Main study parameters/endpoints: Cognitive functioning (attention and working memory), self-efficacy, psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed at baseline (T0), after 6 weeks (T1) and after 12 weeks (T2).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the blended care pathway patients will be instructed to follow a home-based CCT program. Training at home requires a time investment from patients but will also reduce the number of visits to the rehabilitation center. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment instead of traveling to the rehabilitation center for scheduled cognitive training. Increasing patients' responsibility in their recovery process may improve their self-efficacy and HRQoL.
Completion of online questionnaires also requires a certain time investment from patients and might lead to temporary fatigue. Patients may take a break at any moment and continue completing the questionnaires at a later time. By a maximum duration of 45 to 60 minutes per measurement we aim to minimize the burden for patients. There are no risks associated with participation.
- Conditions
- Acquired Brain Injury (Including Stroke)
- Being tested
- Rehacom
- Keywords
- cognition, cognitive impairment, attention deficit, memory disorder, computerized cognitive training, home-based training
- Medical subject headings
- Brain Injuries, Cognitive Dysfunction, Attention Deficit Disorder with Hyperactivity, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehacomDevice
Home-based cognitive training program
| Study group | Role | What they receive |
|---|---|---|
| Early cognitive training, followed by standard care | Experimental | Rehacom, standard care Receives: Device: Rehacom |
| Standard care, followed by cognitive training | Active comparator | Standard care, Rehacom Receives: Device: Rehacom |
What is being measured
The primary outcome is the main question the study is designed to answer.
General cognition
The Montreal Cognitive Assessment (MoCA) will be used for general cognitive screening for all patients at baseline measurement and after 6 and 12 weeks.
Measured: 12 weeks
Selective attention
The D2 test is used to measure change in visual selective attention, processing speed and concentration at the baseline visit, after 6 and 12 weeks.
Measured: 12 weeks
Executive attention
The Stroop Test is used as a measure of mental speed, executive attention and response inhibition in all participants of the study at the baseline measurement, and after 6 and 12 weeks follow-up.
Measured: 12 weeks
Divided attention
The Trail Making Test (TMT A\&B) is used to measure change in executive function (divided attention) and processing speed at the baseline measurement, after 6 weeks and 12 weeks follow up.
Measured: 12 weeks
Working memory
Working memory is measured in all patients at baseline measurement, after 6 weeks and at 12 weeks follow-up with the use of the Digit Span Forward (DSF) and Digit Span Backward (DSB) test (part of the Wechsler adult intelligence scale). It involves the oral presentation of spans of digits. The measure has both a 7-item digits forward task and a 7-item digits backward task, each one with its own individual score.
Together with 'calculation' (also a part of the Wechsler adult intelligence scale), an index for working memory can be calculated.
Measured: 12 weeks
Secondary outcomes (6)
Subjective cognitive complaints
The Cognitive Failures Test (CFQ) is used for all participants at baseline measurement, after 6 weeks and at12 weeks follow-up to assess the frequency with which people experience cognitive failures in everyday life, such as absent-mindedness, slips and errors of perception, memory, and motor functioning. The total score of the scale is the sum of the ratings of the 25 individual items, yielding a score from 0-100. The CFQ has 3 sub-scales: forgetfulness, distractibility, and false triggering.
Measured: 12 weeks
Anxiety and depression
The Dutch Hospital Anxiety and Depression Scale (HADS) is used for all participants at baseline measurement, after 6 and 12 weeks follow-up as a general measure of emotional distress and contains two sub-scales: anxiety and depression. Each sub-scale consists of 7 items, which are rated on a 0 to 3 point rating scale. Sub-scale scores ≥ 8 might indicate the presence of a depressive disorder or an anxiety disorder. Reliability and validity are adequate for several clinical populations, including multiple sclerosis and acquired brain injury.
Measured: 12 weeks
Health-related quality of life (HR-QoL)
The EQ-5D-5L is used for all participants at baseline measurement, after 6 weeks and 12 weeks follow-up as a measurement for HR-QoL. The EQ-5D-5L consists of the 5-item EQ-5D index (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (EQ VAS). Psychometric properties of the Dutch version showed to be good. The five EQ-5D index items are summarized into one weighted overall score, which runs from 0 for the value of death to 1.00 for full health. The EQ VAS ranges from 0 to 100 (worst to best imaginable health state). For the general Dutch population average EQ-5D index = 0.843 and average EQ VAS = 81.36.
Measured: 12 weeks
Fatigue
The Fatigue Assessment Scale (FAS) is used for all participants at baseline measurement, after 6 weeks and 12 weeks follow-up as a measurement for fatigue. The FAS is a simple and short self-administered questionnaire to assess chronic fatigue. Patients' agreement with 10 statements is rated on a 5 points Likert-scale, ranging from 1 ("never") to 5 ("always"). Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Measured: 12 weeks
Coping
The Coping Inventory for Stressful Situations (CISS-Short Form) is used at baseline measurement, after 6 weeks and 12 weeks follow-up to measure coping styles of all participants.
The short version of the CISS is used as a measure of coping with stressful situations. It has 21 items which are rated on a 1 to 5 point rating scale. It contains 3 subscales: task-oriented, emotion-oriented, and avoidance-oriented coping.
Measured: 12 weeks
General Self-Efficacy
The General Self-Efficacy Scale (GSES) is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. This scale explicitly refers to personal agency, i.e., the belief that one's actions are responsible for successful outcomes. Each item is rated on a 4-point rating scale, with total scores ranging from 10 to 40. The GSES is used at baseline, after 6 and 12 weeks follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijndam Revalidatiecentrum, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Majanka H. Heijenbrok-Kal, PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749197
- Sponsor's protocol ID
- 13254
- Other IDs
- 10960102410036
- Acronym
- CoRe@Home
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06749197
- Acronym / sponsor ID
- CoRe@Home / 13254
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- cognition, cognitive impairment, attention deficit, memory disorder, computerized cognitive training, home-based training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Rijndam Revalidatiecentrum, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Patients with acquired brain injury (ABI) may suffer from persistent cognitive deficits and/or subjective cognitive complaints, especially in the domains of attention and working memory. Cognitive deficits are associated with anxiety and depression and may affect social participation and health-related quality of life (HR-QoL). Approximately 25% of the patients with ABI will be referred to an in- and/or outpatient rehabilitation center for multidisciplinary therapy to optimize recovery. Multiple studies suggest that supervised computerized cognitive training (CCT) may enhance cognitive functioning in patients with ABI. Recently, the CCT program RehaCom was introduced as an online version which is suitable for home training. In this study the feasibility and outcomes of implementing home-based CCT into a blended care pathway will be investigated in patients receiving outpatient rehabilitation therapy after ABI.
Objective: The aim of this study is to assess the feasibility and to evaluate the effect of blending a home-based CCT program (RehaCom) in standard care on cognitive functioning in patients after ABI.
The secondary aim is to evaluate the effect of this CCT program on subjective cognitive complaints, self-efficacy, psychological outcome measures and HR-QoL.
Study design: Randomized cross-over trial comparing a 5-week blended care pathway to 5 weeks of standard care within 30 patients with ABI.
Study population: Adults with ABI receiving outpatient rehabilitation therapy.
Intervention: A blended care pathway including 1 cognitive strategy training session of 1 hour per week in the outpatient rehabilitation center in combination with home-based CCT in 4 sessions of 30 minutes per week, during 5 weeks. The standard care pathway includes 2 cognitive training sessions of 1 hour per week in the outpatient rehabilitation center during 5 weeks.
Main study parameters/endpoints: Cognitive functioning (attention and working memory), self-efficacy, psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed at baseline (T0), after 6 weeks (T1) and after 12 weeks (T2).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the blended care pathway patients will be instructed to follow a home-based CCT program. Training at home requires a time investment from patients but will also reduce the number of visits to the rehabilitation center. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment instead of traveling to the rehabilitation center for scheduled cognitive training. Increasing patients' responsibility in their recovery process may improve their self-efficacy and HRQoL.
Completion of online questionnaires also requires a certain time investment from patients and might lead to temporary fatigue. Patients may take a break at any moment and continue completing the questionnaires at a later time. By a maximum duration of 45 to 60 minutes per measurement we aim to minimize the burden for patients. There are no risks associated with participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cognitive training, followed by standard care | Experimental | Device: RehacomRehacom, standard care |
| Standard care, followed by cognitive training | Active comparator | Device: RehacomStandard care, Rehacom |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with acquired brain injury
- receiving outpatient rehabilitation
- sufficient command of Dutch or English language
- internet access
Key exclusion criteria (1 listed)
- incapacitated patients like patients diagnosed with dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehacomHome-based cognitive training program | Device | Early cognitive training, followed by standard care, Standard care, followed by cognitive training |
Primary outcome
General cognition
Time frame: 12 weeks
The Montreal Cognitive Assessment (MoCA) will be used for general cognitive screening for all patients at baseline measurement and after 6 and 12 weeks.
Selective attention
Time frame: 12 weeks
The D2 test is used to measure change in visual selective attention, processing speed and concentration at the baseline visit, after 6 and 12 weeks.
Executive attention
Time frame: 12 weeks
The Stroop Test is used as a measure of mental speed, executive attention and response inhibition in all participants of the study at the baseline measurement, and after 6 and 12 weeks follow-up.
Divided attention
Time frame: 12 weeks
The Trail Making Test (TMT A\&B) is used to measure change in executive function (divided attention) and processing speed at the baseline measurement, after 6 weeks and 12 weeks follow up.
Working memory
Time frame: 12 weeks
Working memory is measured in all patients at baseline measurement, after 6 weeks and at 12 weeks follow-up with the use of the Digit Span Forward (DSF) and Digit Span Backward (DSB) test (part of the Wechsler adult intelligence scale). It involves the oral presentation of spans of digits. The measure has both a 7-item digits forward task and a 7-item digits backward task, each one with its own individual score. Together with 'calculation' (also a part of the Wechsler adult intelligence scale), an index for working memory can be calculated.
6 secondary outcomes
Subjective cognitive complaints
Time frame: 12 weeks
Anxiety and depression
Time frame: 12 weeks
Health-related quality of life (HR-QoL)
Time frame: 12 weeks
Fatigue
Time frame: 12 weeks
Coping
Time frame: 12 weeks
General Self-Efficacy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehacom in people with Acquired Brain Injury (Including Stroke), run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Majanka H Heijenbrok-Kal, PhD (+31 6 28129140, m.heijenbrok@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General cognition (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.