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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)
This is an exploratory Randomized Controlled Trial with the purpose of evaluating the potential of two sets of gamified cognitive and physical exercises in the neurorehabilitation of cognitive deficits following a stroke.
Upon recruitment, eligible study participants (see 'Eligibility Criteria') receive a detailed oral and written description about the scientific background, aims and methods of the study. Additional information will be provided about potential benefits and risks associated with study participation, as well as about the voluntary nature of participation throughout the study. The participant's written informed consent is required for study enrollment.
After inclusion in the study, participants are randomized into one of two different training programs with equal chance of attribution and without possibility of choosing:
Independently of program attribution, participants engage in a pre-training assessment, a six-week training period, a post-training assessment and a 6-month-follow-up assessment. The three assessments include on-site cognitive and physical evaluation, along with the completion of self-report questionnaires concerning subjective cognitive function, mood, and quality of life.
Following the first assessment, study participants engage in a 6-week training period. In both programs, participants engage in 3 weekly trainings of 90 minutes duration each.
A final follow-up visit is scheduled 6 months after the completion of the last training session. The cognitive and physical testing together with the questionnaires will be repeated to examine the long-term effects of the training programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (CTR) | Active Comparator | Computerized Gaming Rehabilitation Program 1 |
|
| Intervention group (INT) | Experimental | Computerized Gaming Rehabilitation Program 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Gaming Rehabilitation Program 1 | Device | Brain training games with physical exercise component. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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) | 6 weeks |
| 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)) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks |
| Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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)). | 6 weeks |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulia Binarelli, PhD | Contact | +41 21 314 25 42 | giulia.binarelli@chuv.ch | |
| Arseny A. Sokolov, Prof MD PhD | Contact | +41 79 556 73 55 | arseny.sokolov@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Arseny A. Sokolov, Prof MD PhD | Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland | Principal Investigator |
| Giulia Binarelli, PhD | Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Zimmermann, P. and B. Fimm, A test battery for attentional performance. Applied Neuropsychology of Attention, Theory, Diagnosis and Rehabilitation 2002: p. 110-151. | ||
| Background | Benedict, R.H.B., et al., Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and Validity. Psychological Assessment, 1996. | ||
| 15012851 | Background | Delis DC, Kramer JH, Kaplan E, Holdnack J. Reliability and validity of the Delis-Kaplan Executive Function System: an update. J Int Neuropsychol Soc. 2004 Mar;10(2):301-3. doi: 10.1017/S1355617704102191. No abstract available. | |
| 22537095 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D003072 | Cognition Disorders |
| D001523 | Mental Disorders |
| D057772 | Vascular System Injuries |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Computerized Gaming Rehabilitation Program 2 | Device | Cognitive training games with physical exercise component. |
|
The Five-Point Test (Regard, 1982) will be used to assess design fluency. |
| 6 weeks |
| 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. | 6 weeks |
| 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). | 6 weeks |
| Change in cognitive flexibility assessed by the TAP Flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Cognitive flexibility will be measured using the subscale 'Flexibility' of the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) | 6 weeks |
| Change in cognitive inhibition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | The Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest Go/NoGo will assess cognitive inhibition. | 6 weeks |
| Change in cognitive multitasking after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | A subtest of a custom-made tablet-based cognitive evaluation tool will measure cognitive multitasking. | 6 weeks |
| Change in covert shift of attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Measured by the corresponding subtest of the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002). | 6 weeks |
| Change in risk of falls and postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Postural stability and risk of falls will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481) | 6 weeks |
| Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Dynamic stability will be assessed by the Four Square Step Test (FSST; Dite et al, 2002), which tests the participant's ability to step over objects forwards, sideways and backwards; the movements of the FSST are comparable to the ones implemented in the training program. | 6 weeks |
| Change in ability to perform a cognitive and physical dual task after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | In order to assess cognitive and motor dual task ability, the study participant will perform the 'Timed Up and Go Cognitive' subtest from the MiniBESTest (Franchignoni et al, 2010). | 6 weeks |
| Change in heart rate after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Heart rate (HR) will be recorded at rest in supine position during a 5-minute window using a chest belt. | 6 weeks |
| Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Heart rate variability (HRv) will be recorded at rest in supine position during a 5-minute window using a chest belt. | 6 weeks |
| Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Determined by the mean of three blood pressure measurements using a sphygmomanometer and a stethoscope. | 6 weeks |
| Everyday physical activity during 6-week training period. | Measuring daily step count and minutes of daily activity using a wrist-attached wearable device will determine everyday physical acitivity during the training period. | 6 weeks |
| Change in everyday life quality after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Study participants will rate everyday life quality using the Quality of Life after Brain Injury questionnaire (QOLIBRI; von Steinbuchel, 2010; 36 items originally, adapted to 35 items for stroke, participants rate applicability of statements on quality of life after stroke from not at all to very)) | 6 weeks |
| Change in everyday life cognitive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Study participants will rate everyday life cognitive function using the Cognitive Failure Questionnaire (CFQ; Broadbent, 1982; 25 items, participants rate the frequency of situations representing cognitive dysfunction in the past 6 months from very often (4 points) to never (0 points), a lower score represents a better subjective cognitive function). | 6 weeks |
| Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Mood is measured by the Hospital Anxiety and Depression Scale (HAD-S; Zigmond and Snaith, 1983), which tests for both anxiety and depression in a 14-item questionnaire (7 items each, participants rate statements on a Likert-Scale from 0-3 for each statement, the maximal score is 28 for each domain, the cut-off 11 for anxiety and depression is points or more). | 6 weeks |
| Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Study participants will rate their degree of apathy using the self-administered Dimensional Apathy Scale (DAS; 24 items; Radakovic and Abrahams, 2014). | 6 weeks |
| Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | Study participants will rate their degree of fatigue on the Modified Fatigue Impact Scale (MFIS; Larson, 2013; 21 items in total, whereof 9 items on a physical subscale, 10 items on a cognitive subscale and 2 items on a psychosocial subscale; every item contains a statement rated on a Likert-Scale from 0-4 (never - almost always), a higher score represents a greater impact of fatigue on the participant's life) | 6 weeks |
| Change in subjective balance after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | The subjective balance of study participants will be measured using the Tinetti Falls Efficacy scale (Tinetti, 1990), a 10-item questionnaire. | 6 weeks |
| 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)). | 6 weeks |
| Background |
| Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27. |
| 16306992 | Background | Vogel EK, McCollough AW, Machizawa MG. Neural measures reveal individual differences in controlling access to working memory. Nature. 2005 Nov 24;438(7067):500-3. doi: 10.1038/nature04171. |
| 7162920 | Background | Regard M, Strauss E, Knapp P. Children's production on verbal and non-verbal fluency tasks. Percept Mot Skills. 1982 Dec;55(3 Pt 1):839-44. doi: 10.2466/pms.1982.55.3.839. No abstract available. |
| 13263471 | Background | REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available. |
| 12422327 | Background | Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469. |
| 20461334 | Background | Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537. |
| 20210602 | Background | von Steinbuchel N, Wilson L, Gibbons H, Hawthorne G, Hofer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077. |
| 7126941 | Background | Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x. |
| 6880820 | Background | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. |
| 24972546 | Background | Radakovic R, Abrahams S. Developing a new apathy measurement scale: Dimensional Apathy Scale. Psychiatry Res. 2014 Nov 30;219(3):658-63. doi: 10.1016/j.psychres.2014.06.010. Epub 2014 Jun 19. |
| 24453758 | Background | Larson RD. Psychometric properties of the modified fatigue impact scale. Int J MS Care. 2013 Spring;15(1):15-20. doi: 10.7224/1537-2073.2012-019. |
| 2229948 | Background | Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239. |
| Background | Brooke, J., SUS: A 'Quick and Dirty' Usability Scale. 1996. |
| 23378841 | Background | Boot WR, Champion M, Blakely DP, Wright T, Souders DJ, Charness N. Video games as a means to reduce age-related cognitive decline: attitudes, compliance, and effectiveness. Front Psychol. 2013 Feb 1;4:31. doi: 10.3389/fpsyg.2013.00031. eCollection 2013. |
| D014947 | Wounds and Injuries |