Think 'n' Move: Motor-cognitive Training in Chronic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Think 'n' Move: Evaluating the Effects of a Concept-guided, Personalized, Motor-cognitive Training in Chronic Stroke - a RCT

Conditions
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Stroke

Intervention / Treatment
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* Other: Concept-guided, personalized, motor-cognitive training by means of an exergame


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 12 weeks, two times per week for 30-40min<br>|
| No Intervention: Control Group<br>Usual care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Montreal Cognitive Assessment Score | Widely used screening tool and cognitive outcome in neurological patients including stroke | week 0, week 12 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Stroke Impact Scale 3.0 Score | Stroke-specific measurement tool assessing patient-reported health-related quality of life | week 0, week 12 and week 24 | 
| Change of Simple Reaction Test Parameters | Widely used reliable and valid neuropsychological test assessing alertness | 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 | 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 | 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 | week 0, week 12 and week 24 | 
| Change of Mental Rotation Test Parameters | Measures the ability to mentally rotate abstract objects | 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. | 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. | week 0, week 12 and week 24 | 
| Change of Outdoor Gait Parameters | Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions. | week 0, week 12 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, gait, mobility, training, chronic stroke, rehabilitation, virtual reality