PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke
- Conditions
- Stroke
- Interventions
- Other: Concept-guided, personalized, motor-cognitive training by means of an exergame
- Registration Number
- NCT05524727
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 38
- Adults (> 18 years) with chronic stroke (≥ 6 months post-stroke)
- Stroke: ischemic or haemorrhagic
- Able to stand for 3 minutes and walk 10 meters, functional ambulation category ≥ 3
- Able to follow a two-stage command
- Able to give informed consent as documented by signature
- Unable or not willing to give informed consent
- Other neurological diseases (e.g. Parkinson's Disease, multiple sclerosis), except cognitive deficits or dementia
- Clinical contra-indications for the study intervention
- Unable to follow the study intervention or the test for the primary endpoint (MoCA), e.g. due to a neglect, aphasia or other language problems
- Overlapping enrolment in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Concept-guided, personalized, motor-cognitive training by means of an exergame Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame
- Primary Outcome Measures
Name Time Method Change of Montreal Cognitive Assessment Score week 0, week 12 and week 24 Widely used screening tool and cognitive outcome in neurological patients including stroke
- Secondary Outcome Measures
Name Time Method Change of Stroop Interference Test Parameters week 0, week 12 and week 24 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
Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs week 0, week 12 and week 24 Widely used, reliable and valid test of mobility and dual-task ability in various populations including stroke.
Change of 10 meter walk test Gait Parameters week 0, week 12 and week 24 Widely used test to assess gait speed and spatiotemporal gait parameters.
Change of N-back test Parameters week 0, week 12 and week 24 Widely used reliable and valid neuropsychological test assessing working memory and related cognitive functions
Change of Stroke Impact Scale 3.0 Score week 0, week 12 and week 24 Stroke-specific measurement tool assessing patient-reported health-related quality of life
Change of Simple Reaction Test Parameters week 0, week 12 and week 24 Widely used reliable and valid neuropsychological test assessing alertness
Change of Trail Making Test A & B Parameters week 0, week 12 and week 24 Widely used reliable and valid neuropsychological test assessing processing speed and executive functions
Change of Mental Rotation Test Parameters week 0, week 12 and week 24 Measures the ability to mentally rotate abstract objects
Change of Outdoor Gait Parameters week 0, week 12 and week 24 Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.
Trial Locations
- Locations (3)
Ambulante Reha Triemli Zürich
🇨🇭Zurich, Switzerland
University Hospital Zürich
🇨🇭Zurich, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Zurich, Switzerland