Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
NCT Number: NCT05169632
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brain training games with physical exercise component.
Cognitive training games with physical exercise component.
Time frame: 6 weeks
Cognitive interference is measured using the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan, Kramer, 2001) Stroop Test
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
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)
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))
Time frame: 6 weeks
Visual working memory will be assessed via performance on the computerized 'Filter task' (Vogel, 2005).
Time frame: 6 weeks
The Five-Point Test (Regard, 1982) will be used to assess design fluency.
Time frame: 6 weeks
The Trail-Making-Test Part A (Reitan, 1955) will be used to assess processing speed.
Time frame: 6 weeks
Cognitive flexibility will be measured using the Trail-Making-Test B (TMT-B; Reitan, 1955).
Time frame: 6 weeks
Cognitive flexibility will be measured using the subscale 'Flexibility' of the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002)
Time frame: 6 weeks
The Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest Go/NoGo will assess cognitive inhibition.
Time frame: 6 weeks
A subtest of a custom-made tablet-based cognitive evaluation tool will measure cognitive multitasking.
Time frame: 6 weeks
Measured by the corresponding subtest of the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002).
Time frame: 6 weeks
Postural stability and risk of falls will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481)
Time frame: 6 weeks
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.
Time frame: 6 weeks
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).
Time frame: 6 weeks
Heart rate (HR) will be recorded at rest in supine position during a 5-minute window using a chest belt.
Time frame: 6 weeks
Heart rate variability (HRv) will be recorded at rest in supine position during a 5-minute window using a chest belt.
Time frame: 6 weeks
Determined by the mean of three blood pressure measurements using a sphygmomanometer and a stethoscope.
Time frame: 6 weeks
Measuring daily step count and minutes of daily activity using a wrist-attached wearable device will determine everyday physical acitivity during the training period.
Time frame: 6 weeks
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))
Time frame: 6 weeks
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).
Time frame: 6 weeks
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).
Time frame: 6 weeks
Study participants will rate their degree of apathy using the self-administered Dimensional Apathy Scale (DAS; 24 items; Radakovic and Abrahams, 2014).
Time frame: 6 weeks
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)
Time frame: 6 weeks
The subjective balance of study participants will be measured using the Tinetti Falls Efficacy scale (Tinetti, 1990), a 10-item questionnaire.
Time frame: 6 weeks
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 weeks
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)).
Contact information is provided by the study sponsor or research team.
Arseny A. Sokolov, Prof MD PhD
CONTACT
Giulia Binarelli, PhD
CONTACT
Centre Hospitalier Universitaire Vaudois
Other
Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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