COMPuter-assisted Self-training to Improve EXecutive Function
- Conditions
- StrokeCardiac ArrestParkinson DiseaseCognitive DysfunctionExecutive Dysfunction
- Interventions
- Behavioral: General computer-based cognitive stimulationBehavioral: Computer-based cognitive rehabilitation (CBCR)
- Registration Number
- NCT04229056
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 307
- A diagnose of stroke, cardiac arrest or Parkinson's disease.
- Aged 18 years or older.
- Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards
- Computer and internet access at home.
- Providing informed consent.
Inclusion criteria specific for stroke
- Inclusion within 6 months post-stroke
- Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
- Initial stroke severity >/= NIHSS 3.
Inclusion criteria specific for cardiac arrest
• Inclusion within 6 months post ictus.
Inclusion criteria specific for Parkinson's disease
- Clinical diagnosis of PD.
- Anti-parkinsonian medical treatment (dopaminergic or other).
- Informed consent not provided
- Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator
- Not able to participate according to investigator
Exclusion criteria specific for stroke
- Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time)
- Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction.
Exclusion criteria specific for cardiac arrest • None
Exclusion criteria specific for PD
• Diagnosis of PD Dementia according to the MDS PD Dementia criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General computer-based cognitive stimulation General computer-based cognitive stimulation 350 patients (200 with stroke, 100 with Parkinson's disease and 50 with heart attack) 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. Specific computer-based cognitive rehabilitation Computer-based cognitive rehabilitation (CBCR) 350 patients (200 with stroke, 100 with Parkinson's disease and 50 with heart attack) 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.
- Primary Outcome Measures
Name Time Method CABPad Working Memory Test After the end of the intervention (8 weeks after baseline) Test of working memory. The higher score the better (theoretically infinite score)
- Secondary Outcome Measures
Name Time Method CABPad Working Memory Test - 3 months follow-up At follow-up visit 3 months after end of intervention Test of working memory. The higher score the better (theoretically infinite score)
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL) Directly after the intervention, eight weeks after inclusion Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.
Trail Making A At follow-up visit 3 months after the end of the intervention Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
Trail Making B At follow-up visit 3 months after the end of the intervention Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
SDMT At follow-up visit 3 months after the end of the intervention Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
Phonological verbal fluency test At follow-up visit 3 months after the end of the intervention Test of verbal phonological fluency. The higher score the better (theoretically infinite score)
Categorical verbal fluency test At follow-up visit 3 months after the end of the intervention Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
Fear questionnaire At follow-up visit 3 months after the end of the intervention Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear
mrs: Modified Rankin Scale At follow-up visit 3 months after the end of the intervention Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) At follow-up visit 3 months after the end of the intervention 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.
EuroQol-5 domain (EQ-5D-5L) At follow-up visit 3 months after the end of the intervention 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
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease) Directly after the intervention, eight weeks after inclusion 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.
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease) At follow-up visit 3 months after the end of the intervention 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.
Compliance Directly after the intervention, eight weeks after inclusion Monitoring of total time spent training in minutes
PHQ-9 (Patient health questionnaire 9) At follow-up visit 3 months after the end of the intervention 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.
2) visual analogue scale (1-10) Directly after the intervention, eight weeks after inclusion 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.
Trial Locations
- Locations (2)
Rigshospitalet
🇩🇰Copenhagen, Denmark
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark