Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois
About this trial
WHO: 32 participants with executive deficits related to a stroke, able to engage in moderate physical activity.
WHY: Around one third of stroke patients suffer from cognitive deficits in the long term, which have a detrimental impact on everyday personal and professional life. The purpose of this study is to evaluate two sets of computerized exercises combining cognitive and physical effort to see if they can improve executive function.
WHAT: Study participants first undergo cognitive and physical assessments. Additional questionnaires will assess mood, everyday life cognition, function and quality. This will be followed by a 6 week training period with 3 training sessions a week. The effect of the cognitive and physical training will be measured in a post-training evaluation session. Six months after completion of the training, the study will evaluate cognitive and physical abilities of participants to study long-term effects of the respective training program.
WHERE: Both the evaluation and the training sessions will be conducted on the premises of the Centre Hospitalier Universitaire Vaudoise (Pavillon 4, Avenue de Beaumont, 1005 Lausanne, Switzerland)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Ischemic or haemorrhagic cerebral stroke ≥ 8 weeks before study inclusion
Cognitive complaint and/or clinical impression of dysexecutive syndrome
Z-Score < -1.0 in at least two of the following domains
Disqualifiers
Major neurocognitive disorder according to the DSM-5
Proximal extremity paresis grade < M4 on the Medical Research Council (MRC) Scale for Muscle Strength in at least one of four extremities
Insufficient visual acuity, visual field or hemispatial attention to engage in the training
Inability to discriminate colour: < 12 points on the Ishihara test
Trial design
Design model
Parallel
Treatments tested in this trial
Computerized Gaming Rehabilitation Program 1
DeviceBrain training games with physical exercise component.
Computerized Gaming Rehabilitation Program 2
DeviceCognitive training games with physical exercise component.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Control group (CTR)Active comparator 1 intervention
Group B: Intervention group (INT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Cognitive interference is measured using the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan, Kramer, 2001) Stroop Test
Time frame
6 weeks2
Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Divided attention is measured using the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest for divided attention
Time frame
6 weeks3
Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Visuospatial short term memory is measured by the immediate recall of the Brief Visuospatial Memory Test-Revised (BVMT-R; Benedict, 1996)
Time frame
6 weeks4
Change in subjective executive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Subjective executive function is measured by the Working Memory Questionnaire (WMQ; Vallat-Azouvi et al, 2012; 30 items, participants rate 10 statements on storage, attention and executive domain on a Likert-scale from 1-5 (not at all - extremely))
Time frame
6 weeksSecondary outcomes
1
Change in visual working memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Visual working memory will be assessed via performance on the computerized 'Filter task' (Vogel, 2005).
Time frame
6 weeks2
Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
The Five-Point Test (Regard, 1982) will be used to assess design fluency.
Time frame
6 weeks3
Change in processing speed after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
The Trail-Making-Test Part A (Reitan, 1955) will be used to assess processing speed.
Time frame
6 weeks4
Change in cognitive flexibility assessed by the TMT-B after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Cognitive flexibility will be measured using the Trail-Making-Test B (TMT-B; Reitan, 1955).
Time frame
6 weeksOther outcomes
1
Subjective experience with technology used in study
Regardless of training group attribution, study participants will rate the user-friendliness and the experience of the training using the 10-item System Usability Scale (Brooke, 1996; 10 statements about system usability rated on a Likert-scale from 1-5 (strongly disagree - strongly agree)).
Time frame
6 weeks2
Perception of game training
Regardless of training group attribution, study participants will rate their perception of game training using the Perception of game training questionnaire (Boot et al, 2013; 4 statements on enjoyment, challenge, frustration and motivation associated with the game, participants rate their agreement with the statement on a Likert-scale from 1 (lowest) to 7 (highest)).
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov