An interventional study of Concept-guided, personalized, motor-cognitive training by means of an exergame in Stroke, sponsored by University of Zurich. Active, not recruiting at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
In Switzerland, approximately 20'000 persons suffer a stroke each year. Despite carefully considered rehabilitation programs, full recovery is achieved only in a small proportion of stroke survivors (www.swissheart.ch). Studies suggest that motor-cognitive trainings can improve gait, balance, and mobility in chronic stoke survivors. However, little is known about the effect of motor-cognitive trainings on cognitive functioning in chronic stroke.
The aim of this study is to evaluate the effects of a motor-cognitive training added to usual care compared to usual care alone on cognitive functions, single- and dual-task mobility, gait and health-related quality of life.
In this single-blind RCT, 38 participants will be allocated randomly to either the intervention group (usual care + motor-cognitive training by means of an exergame for 12 weeks, 2x/week for 30-40 minutes) or the control group (usual care only). Both groups will attend three assessments, at baseline, post-intervention (12 weeks after baseline), and at follow-up (24 weeks after baseline). Global cognitive functioning will be the primary endpoint and a linear mixed model will be used for analysis.
Motor-cognitive trainings, especially exergames, bear the potential for further development of innovative long-term rehabilitation solutions for chronic stroke survivors. Cognitive deficits are a common unmet need restricting daily activities mentioned by chronic stroke survivors. Exergame training following personally tailored progression to generate optimal training load may help addressing this unmet need. Therefore, this study will contribute to the on-going research objective on how to improve the long-term care of stroke patients.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 38 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame
Other: Concept-guided, personalized, motor-cognitive training by means of an exergame
Usual care only
12 weeks, two times per week for 30-40min
Change of Montreal Cognitive Assessment Score
Widely used screening tool and cognitive outcome in neurological patients including stroke
Time frame: week 0, week 12 and week 24
Change of Stroke Impact Scale 3.0 Score
Stroke-specific measurement tool assessing patient-reported health-related quality of life
Time frame: week 0, week 12 and week 24
Change of Simple Reaction Test Parameters
Widely used reliable and valid neuropsychological test assessing alertness
Time frame: week 0, week 12 and week 24
Change of Trail Making Test A & B Parameters
Widely used reliable and valid neuropsychological test assessing processing speed and executive functions
Time frame: week 0, week 12 and week 24
Change of Stroop Interference Test Parameters
Widely used reliable and valid neuropsychological test assessing the ability to inhibit the reaction to a more dominant stimulus in favour of the inquired reaction to a less dominant stimulus
Time frame: week 0, week 12 and week 24
Change of N-back test Parameters
Widely used reliable and valid neuropsychological test assessing working memory and related cognitive functions
Time frame: week 0, week 12 and week 24
Change of Mental Rotation Test Parameters
Measures the ability to mentally rotate abstract objects
Time frame: week 0, week 12 and week 24
Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs
Widely used, reliable and valid test of mobility and dual-task ability in various populations including stroke.
Time frame: week 0, week 12 and week 24
Change of 10 meter walk test Gait Parameters
Widely used test to assess gait speed and spatiotemporal gait parameters.
Time frame: week 0, week 12 and week 24
Change of Outdoor Gait Parameters
Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.
Time frame: week 0, week 12 and week 24
Compliance Rate
attended sessions / offered sessions
Time frame: week 12
Adherence Rate
attended training time / offered training time
Time frame: week 12
Perceived Motor-Cognitive Task Difficulty
visual analogue scale after each training session, based on cognitive load theory, scale from 1-9, where 9 symbolizes most difficult
Time frame: twice per week, week 0-12
Perceived Performance
visual analogue scale after each training session, performance item of the National Aeronautics and Space Administration - Task Load Index, scale from 0 to 20, where 20 symbolizes highest performance
Time frame: twice per week, week 0-12
Dose and Content of Usual Care
according to weekly questionnaire, based on TIDIeR checklist
Time frame: once per week, week 0-24
Amount and Intensity of General Physical and Cognitive Activity
according to weekly questionnaire, based on TIDIeR checklist
Time frame: once per week, week 0-24
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Zurich