Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With ABI
NCT06749197, Not applicable, Recruiting, Erasmus Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With ABI | ClinicalTrials.gov |
| NCT number | NCT06749197 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Erasmus Medical Center | ClinicalTrials.gov |
| Conditions | Acquired Brain Injury (Including Stroke) | ClinicalTrials.gov |
| Interventions | Rehacom | ClinicalTrials.gov |
| First posted | 2024-12-27 | ClinicalTrials.gov |
| Last updated | 2026-05-01 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | General cognition | 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. | ClinicalTrials.gov |
| Primary | Selective attention | 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. | ClinicalTrials.gov |
| Primary | Executive attention | 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. | ClinicalTrials.gov |
| Primary | Divided attention | 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. | ClinicalTrials.gov |
| Primary | Working memory | 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. | ClinicalTrials.gov |
| Secondary | Subjective cognitive complaints | 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Anxiety and depression | 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Health-related quality of life (HR-QoL) | 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Fatigue | 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Coping | 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | General Self-Efficacy | 12 weeks | 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. | ClinicalTrials.gov |
| Other | Personality traits neuroticism and extraversion | Baseline | The Eysenck Personality Questionnaire Brief Version (EPQ-BV) is used at baseline measurement to measure level of neuroticism and level of extraversion of all participants. The EPQ-BV is a revised version of the EPQ-S to measure individuals on two primary personality traits in Eysenck's personality theory (1990). It consists of two measures, one for extraversion (12 items) and one for neuroticism (12 items). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)