StrokeNCT05169632
Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients
A study testing Computerized Gaming Rehabilitation Program 1 and Computerized Gaming Rehabilitation Program 2 in people with Stroke and Executive Dysfunction, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Executive Dysfunction
- What is being tested?
- Computerized Gaming Rehabilitation Program 1 and Computerized Gaming Rehabilitation Program 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Cognitive flexibility (Trail-Making Test B/A)
- Cognitive interference (Stroop color word interference task)
Show all 9Show fewer
- Divided attention (TAP divided attention)
- Working memory (TAP working memory, Forward Digit Span, Backward Digit Span)
- Design fluency (Five-points test)
Who cannot join
- 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
- Changes over the last 4 weeks in antidepressive, anxiolytic or in acetylcholinesterase inhibitor drugs
- Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report)
Show all 11Show fewer
- Clinically unstable cardio-vascular disease
- Falls in the past 12 weeks as evaluated in the enrolment interview [Hopkins Falls Grading Scale (Grade >1)]
- High risk of falling according to a score of over 15 seconds on the Four Square Step Test (FSST)
- Insufficient knowledge or capacity of French to follow instructions
- Incapacity or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, 1011
Aurélie Manuel Stocker, PhD, +41 21 314 25 42, aurelie.manuel-stocker@chuv.ch
About this study
Official title: Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled 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.
Read more
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)
Read the detailed description
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:
- Program 1 involves brain training games with a physical exercise component.
- Program 2 involves cognitive training games with a physical exercise component.
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.
- Conditions
- Stroke, Executive Dysfunction
- Being tested
- Computerized Gaming Rehabilitation Program 1, Computerized Gaming Rehabilitation Program 2
- Keywords
- Stroke Rehabilitation, Neurological Rehabilitation, Exercise Therapy, Brain Training, Nervous System Diseases, Neurocognitive Disorders, Cognition Disorders, Mental Disorders, Vascular System Injuries, Cerebrovascular Disorders, Multimodal Intervention, e-Health, Digital Intervention, Exergame
- Medical subject headings
- Stroke, Nervous System Diseases, Neurocognitive Disorders, Cognition Disorders, Mental Disorders, Vascular System Injuries, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Gaming Rehabilitation Program 1Device
Brain training games with physical exercise component.
Computerized Gaming Rehabilitation Program 2Device
Cognitive training games with physical exercise component.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CTR) | Active comparator | Computerized Gaming Rehabilitation Program 1 Receives: Device: Computerized Gaming Rehabilitation Program 1 |
| Intervention group (INT) | Experimental | Computerized Gaming Rehabilitation Program 2 Receives: Device: Computerized Gaming Rehabilitation Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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))
Measured: 6 weeks
Secondary outcomes (21)
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).
Measured: 6 weeks
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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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))
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start17 Mar 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Arseny Sokolov, MD, PhD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Arseny A. Sokolov, Prof MD PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, SwitzerlandGiulia Binarelli, PhD, Study chair, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169632
- Sponsor's protocol ID
- CHUV-DNC-CCT-STROKE-2021
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2021
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmermann, P. and B. Fimm, A test battery for attentional performance. Applied Neuropsychology of Attention, Theory, Diagnosis and Rehabilitation 2002: p. 110-151.
Benedict, R.H.B., et al., Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and Validity. Psychological Assessment, 1996.
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.
PubMed 15012851Vallat-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.
PubMed 22537095Vogel 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.
PubMed 16306992Regard 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.
PubMed 7162920REITAN 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.
PubMed 13263471Dite 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.
PubMed 12422327Franchignoni 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.
PubMed 20461334von 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.
PubMed 20210602Broadbent 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.
PubMed 7126941Zigmond 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.
PubMed 6880820Radakovic 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.
PubMed 24972546Larson 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.
PubMed 24453758Tinetti 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.
PubMed 2229948
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05169632
- Acronym / sponsor ID
- CHUV-DNC-CCT-STROKE-2021
- Conditions
- Stroke, Executive Dysfunction
- Keywords
- Stroke Rehabilitation, Neurological Rehabilitation, Exercise Therapy, Brain Training, Nervous System Diseases, Neurocognitive Disorders, Cognition Disorders, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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:
- Program 1 involves brain training games with a physical exercise component.
- Program 2 involves cognitive training games with a physical exercise component.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (CTR) | Active comparator | Device: Computerized Gaming Rehabilitation Program 1Computerized Gaming Rehabilitation Program 1 |
| Intervention group (INT) | Experimental | Device: Computerized Gaming Rehabilitation Program 2Computerized Gaming Rehabilitation Program 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- Changes over the last 4 weeks in antidepressive, anxiolytic or in acetylcholinesterase inhibitor drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Gaming Rehabilitation Program 1Brain training games with physical exercise component. | Device | Control group (CTR) |
| Computerized Gaming Rehabilitation Program 2Cognitive training games with physical exercise component. | Device | Intervention group (INT) |
Primary outcome
Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Cognitive interference is measured using the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan, Kramer, 2001) Stroop Test
Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Divided attention is measured using the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest for divided attention
Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Visuospatial short term memory is measured by the immediate recall of the Brief Visuospatial Memory Test-Revised (BVMT-R; Benedict, 1996)
Change in subjective executive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
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))
21 secondary outcomes
Change in visual working memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in processing speed after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 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)
Time frame: 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)
Time frame: 6 weeks
Change in cognitive inhibition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in cognitive multitasking after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in covert shift of attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 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)
Time frame: 6 weeks
Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 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)
Time frame: 6 weeks
Change in heart rate after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 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)
Time frame: 6 weeks
Everyday physical activity during 6-week training period.
Time frame: 6 weeks
Change in everyday life quality after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in everyday life cognitive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Change in subjective balance after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- BackgroundZimmermann, P. and B. Fimm, A test battery for attentional performance. Applied Neuropsychology of Attention, Theory, Diagnosis and Rehabilitation 2002: p. 110-151.
- BackgroundBenedict, R.H.B., et al., Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and Validity. Psychological Assessment, 1996.
- Background: PubMed 15012851Delis 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.
- Background: PubMed 22537095Vallat-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.
- Background: PubMed 16306992Vogel 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.
- Background: PubMed 7162920Regard 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.
- Background: PubMed 13263471REITAN 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arseny A. Sokolov, Prof MD PhD principal investigator
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
Giulia Binarelli, PhD study chair
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Gaming Rehabilitation Program 1 and Computerized Gaming Rehabilitation Program 2 in people with Stroke and Executive Dysfunction, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Binarelli, PhD (+41 21 314 25 42, giulia.binarelli@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169632, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.