Clinical trial NCT05524727: PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke
Official title: PEMOCS: Effects of a Concept-guided, PErsonalized, MOtor-Cognitive Training in Chronic Stroke - a RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: cognition
gait
mobility
training
chronic stroke
rehabilitation
virtual reality
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Montreal Cognitive Assessment Score
timeFrame: week 0, week 12 and week 24
Secondary outcomes:
measure: Change of Stroke Impact Scale 3.0 Score
timeFrame: week 0, week 12 and week 24
measure: Change of Simple Reaction Test Parameters
timeFrame: week 0, week 12 and week 24
measure: Change of Trail Making Test A & B Parameters
timeFrame: week 0, week 12 and week 24
measure: Change of Stroop Interference Test Parameters
timeFrame: week 0, week 12 and week 24
measure: Change of N-back test Parameters
timeFrame: week 0, week 12 and week 24
measure: Change of Mental Rotation Test Parameters
timeFrame: week 0, week 12 and week 24
measure: Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs
timeFrame: week 0, week 12 and week 24
measure: Change of 10 meter walk test Gait Parameters
timeFrame: week 0, week 12 and week 24
measure: Change of Outdoor Gait Parameters
timeFrame: week 0, week 12 and week 24
Other outcomes:
measure: Compliance Rate
timeFrame: week 12
measure: Adherence Rate
timeFrame: week 12
measure: Perceived Motor-Cognitive Task Difficulty
timeFrame: twice per week, week 0-12
measure: Perceived Performance
timeFrame: twice per week, week 0-12
measure: Dose and Content of Usual Care
timeFrame: once per week, week 0-24
measure: Amount and Intensity of General Physical and Cognitive Activity
timeFrame: once per week, week 0-24
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
city: Zurich
country: Switzerland
facility: Ambulante Reha Triemli Zürich
city: Zurich
country: Switzerland
facility: University Hospital Zürich
Study officials:
References: