Cardiac Arrest, Cognitive Dysfunction, Executive Dysfunction, Parkinson Disease, Stroke
Conditions
Keywords
parkinson disease, stroke, cardiac arrest, executive dysfunction, cognitive dysfunction, computer-based cognitive rehabilitation
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.
Interventions
BEHAVIORALGeneral computer-based cognitive stimulation
For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.
CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
Sponsors
Rigshospitalet, Denmark
University of Glasgow
University of Basel
Copenhagen Trial Unit, Center for Clinical Intervention Research
Hjernesagen
Göteborg University
Aalborg University Hospital
Neurorehabilitering - Kbh, City of Copenhagen
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Two parallel groups will be included in this study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL) | At follow-up visit 3 months after the end of the intervention | Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better. |
| Trail Making A | Directly after the intervention, eight weeks after inclusion | Test of processing speed and visual attention. The lower score the better (theoretically infinite score) |
| Trail Making B | Directly after the intervention, eight weeks after inclusion | Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score) |
| SDMT | Directly after the intervention, eight weeks after inclusion | Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score) |
| Phonological verbal fluency test | Directly after the intervention, eight weeks after inclusion | Test of verbal phonological fluency. The higher score the better (theoretically infinite score) |
| Categorical verbal fluency test | Directly after the intervention, eight weeks after inclusion | Test of verbal categorical fluency. The higher score the better (theoretically infinite score) |
| Fear questionnaire | Directly after the intervention, eight weeks after inclusion | Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear |
| 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) |
| IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) | Directly after the intervention, eight weeks after inclusion | 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) | Directly after the intervention, eight weeks after inclusion | 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) | Directly after the intervention, eight weeks after inclusion | 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. |
| mrs: Modified Rankin Scale | Directly after the intervention, eight weeks after inclusion | Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability. |
Countries
Denmark
Contacts
Primary ContactHanne Christensen, Professor
Backup ContactKatrine Sværke, M.Sc. Psych.
Outcome results
None listed