Clinical trial NCT05169632: Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients
Official title: Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Executive Dysfunction
Keywords: Stroke Rehabilitation
Neurological Rehabilitation
Exercise Therapy
Brain Training
Nervous System Diseases
Neurocognitive Disorders
Cognition Disorders
Mental Disorders
Vascular System Injuries
Cerebrovascular Disorders
Multimodal Intervention
e-Health
Digital Intervention
Exergame
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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:

* Program 1 involves brain training games with a physical exercise component.
* Program 2 involves cognitive training games with a physical exercise component.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Ischemic or haemorrhagic cerebral stroke ≥ 8 weeks before study inclusion
* Cognitive complaint and/or clinical impression of dysexecutive syndrome
* Z-Score \< -1.0 in at least two of the following domains

  * Cognitive flexibility (Trail-Making Test B/A)
  * Cognitive interference (Stroop color word interference task)
  * Divided attention (TAP divided attention)
  * Working memory (TAP working memory, Forward Digit Span, Backward Digit Span)
  * Design fluency (Five-points test)

Exclusion Criteria:

* Major neurocognitive disorder according to the DSM-5
* Proximal extremity paresis grade \< M4 on the Medical Research Council (MRC) Scale for Muscle Strength in at least one of four extremities
* Insufficient visual acuity, visual field or hemispatial attention to engage in the training
* Inability to discriminate colour: \< 12 points on the Ishihara test
* Changes over the last 4 weeks in antidepressive, anxiolytic or in acetylcholinesterase inhibitor drugs
* Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report)
* Clinically unstable cardio-vascular disease
* Falls in the past 12 weeks as evaluated in the enrolment interview \[Hopkins Falls Grading Scale (Grade \>1)\]
* High risk of falling according to a score of over 15 seconds on the Four Square Step Test (FSST)
* Insufficient knowledge or capacity of French to follow instructions
* Incapacity or unwillingness to provide informed consent

Primary outcomes:
measure: Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in subjective executive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in visual working memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in processing speed after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in cognitive flexibility assessed by the TMT-B after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in cognitive flexibility assessed by the TAP Flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in cognitive inhibition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in cognitive multitasking after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in covert shift of attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in risk of falls and postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in ability to perform a cognitive and physical dual task after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in heart rate after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Everyday physical activity during 6-week training period.
timeFrame: 6 weeks
measure: Change in everyday life quality after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in everyday life cognitive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
measure: Change in subjective balance after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
timeFrame: 6 weeks
Other outcomes:
measure: Subjective experience with technology used in study
timeFrame: 6 weeks
measure: Perception of game training
timeFrame: 6 weeks
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital (CHUV)
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
name: Arseny A. Sokolov, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
name: Giulia Binarelli, PhD
role: STUDY_CHAIR
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