Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| University of Glasgow | OTHER |
| University of Basel | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research |
Not provided
Not provided
Not provided
This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer
This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific computer-based cognitive rehabilitation | Experimental | 154 patients will be allocated to specific computer-based cognitive rehabilitation. This group will train with 10 exercises from the cognitive rehabilitation software 'Scientific Brain training PRO'. These 10 exercises are designed to train various executive functions. |
|
| General computer-based cognitive stimulation | Active Comparator | 154 patients will be allocated to general computer-based cognitive stimulation. This group will train with 10 generally mentally stimulating games on a website specifically designed for this trial. These 10 games are chosen because they are believed to have a low load on executive functions but stimulate over-all concentration and visuoperceptual abilities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-based cognitive rehabilitation (CBCR) | Behavioral | CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions. |
| Measure | Description | Time Frame |
|---|---|---|
| CABPad Working Memory Test | Test of working memory. The higher score the better (theoretically infinite score) | After the end of the intervention (8 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| CABPad Working Memory Test - 3 months follow-up | Test of working memory. The higher score the better (theoretically infinite score) | At follow-up visit 3 months after end of intervention |
| Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL) |
Not provided
Inclusion Criteria:
Inclusion criteria specific for stroke
Inclusion criteria specific for cardiac arrest
• Inclusion within 6 months post ictus.
Inclusion criteria specific for Parkinson's disease
Exclusion Criteria:
Exclusion criteria specific for stroke
Exclusion criteria specific for cardiac arrest • None
Exclusion criteria specific for PD
• Diagnosis of PD Dementia according to the MDS PD Dementia criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanne Christensen, Professor | Contact | +45 38 63 50 70 | hanne.krarup.christensen@regionh.dk | |
| Katrine Sværke, M.Sc. Psych. | Contact | 004521251087 | katrine.svaerke.schioeler@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Hanne Christensen, Professor | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41857604 | Derived | Svaerke K, Christensen L, Lokkegaard A, Kjaergaard J, Jacobsen JC, Engelter S, Modrau B, Quinn T, Traenka C, Sunnerhagen KS, Christensen H. The COMPEX-trial: computer-based cognitive rehabilitation to improve executive function versus unspecific training in patients after stroke, cardiac arrest or in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2026 Mar 19;27(1):310. doi: 10.1186/s13063-026-09623-5. |
Not provided
Not provided
This is currently undecided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020521 | Stroke |
| D006323 | Heart Arrest |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| OTHER |
| Hjernesagen | UNKNOWN |
| Göteborg University | OTHER |
| Aalborg University Hospital | OTHER |
| Neurorehabilitering - Kbh, City of Copenhagen | OTHER |
Two parallel groups will be included in this study
Not provided
Not provided
Because of the nature of the intervention, masking participants and investigators is not possible. Outcome assessors will be masked to the group allocation of participants.
| General computer-based cognitive stimulation | Behavioral | For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation. |
|
Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better. |
| At follow-up visit 3 months after the end of the intervention |
| Trail Making A | Test of processing speed and visual attention. The lower score the better (theoretically infinite score) | Directly after the intervention, eight weeks after inclusion |
| Trail Making A | Test of processing speed and visual attention. The lower score the better (theoretically infinite score) | At follow-up visit 3 months after the end of the intervention |
| Trail Making B | Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score) | Directly after the intervention, eight weeks after inclusion |
| Trail Making B | Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score) | At follow-up visit 3 months after the end of the intervention |
| SDMT | Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score) | Directly after the intervention, eight weeks after inclusion |
| SDMT | Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score) | At follow-up visit 3 months after the end of the intervention |
| Phonological verbal fluency test | Test of verbal phonological fluency. The higher score the better (theoretically infinite score) | Directly after the intervention, eight weeks after inclusion |
| Phonological verbal fluency test | Test of verbal phonological fluency. The higher score the better (theoretically infinite score) | At follow-up visit 3 months after the end of the intervention |
| Categorical verbal fluency test | Test of verbal categorical fluency. The higher score the better (theoretically infinite score) | Directly after the intervention, eight weeks after inclusion |
| Categorical verbal fluency test | Test of verbal categorical fluency. The higher score the better (theoretically infinite score) | At follow-up visit 3 months after the end of the intervention |
| Fear questionnaire | Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear | Directly after the intervention, eight weeks after inclusion |
| Fear questionnaire | Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear | At follow-up visit 3 months after the end of the intervention |
| mrs: Modified Rankin Scale | Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability. | Directly after the intervention, eight weeks after inclusion |
| mrs: Modified Rankin Scale | Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability. | At follow-up visit 3 months after the end of the intervention |
| IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) | Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability. | Directly after the intervention, eight weeks after inclusion |
| IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) | Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability. | At follow-up visit 3 months after the end of the intervention |
| EuroQol-5 domain (EQ-5D-5L) | Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability . Higher score indicates more severe disability. Completed by patient and partner | Directly after the intervention, eight weeks after inclusion |
| EuroQol-5 domain (EQ-5D-5L) | Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability. Higher score indicates more severe disability. Completed by patient and partner | At follow-up visit 3 months after the end of the intervention |
| PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease) | Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability. | Directly after the intervention, eight weeks after inclusion |
| PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease) | Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability. | At follow-up visit 3 months after the end of the intervention |
| Compliance | Monitoring of total time spent training in minutes | Directly after the intervention, eight weeks after inclusion |
| PHQ-9 (Patient health questionnaire 9) | Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability. | Directly after the intervention, eight weeks after inclusion |
| PHQ-9 (Patient health questionnaire 9) | Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability. | At follow-up visit 3 months after the end of the intervention |
| 2) visual analogue scale (1-10) | After last session: how much they liked doing the training and if they would recommend the intervention to somebody else in their situation. Higher score indicates they liked the training more. | Directly after the intervention, eight weeks after inclusion |
| Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL) | Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better. | Directly after the intervention, eight weeks after inclusion |
| Rigshospitalet | Recruiting | Copenhagen | Denmark |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |