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)

Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients

Stroke

Executive Dysfunction

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.

      Before the start of the training, participants are required to perform several cognitive and
      physical tests and fill out a number of questionnaires on subjective cognitive function, mood
      and quality of life. The exercises and the questionnaires serve as a baseline evaluation of
      cognitive and physical function.

      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.

      After completion of the training period, study participants engage in a post-training
      assessment to evaluate the effect of training on cognitive and physical performance. This
      session incorporates the same tasks and questionnaires as in the pre-training visit. The aim
      of the post-training assessment is to demonstrate immediate training effect of the two
      programs.

      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.

Computerized Gaming Rehabilitation Program 1

Computerized Gaming Rehabilitation Program 2

Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial

Cognitive interference is measured using the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan, Kramer, 2001) Stroop Test

Divided attention is measured using the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest for divided attention

Visuospatial working memory is measured by the immediate recall of the Brief Visuospatial Memory Test-Revised (BVMT-R; Benedict, 1996)

Subjective executive function is measured by the Working Memory Questionnaire (WMQ; Vallat-Azouvi et al, 2012; 30 items, participants rate 10 statements on storage, attention and executive domain on a Likert-scale from 1-5 (not at all - extremely))

Professor

Visual working memory will be assessed via performance on the computerized 'Filter task' (Vogel, 2005).

The Five-Point Test (Regard, 1982) will be used to assess design fluency.

The Trail-Making-Test Part A (Reitan, 1955) will be used to assess processing speed.

Cognitive flexibility will be measured using the Trail-Making-Test B (TMT-B; Reitan, 1955).

Cognitive flexibility will be measured using the subscale 'Flexibility' of the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002)

The Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest Go/NoGo will assess cognitive inhibition.

A subtest of a custom-made tablet-based cognitive evaluation tool will measure cognitive multitasking.

Measured by the corresponding subtest of the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002).

Postural stability and risk of falls will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481)

Dynamic stability will be assessed by the Four Square Step Test (FSST; Dite et al, 2002), which tests the participant's ability to step over objects forwards, sideways and backwards; the movements of the FSST are comparable to the ones implemented in the training program.

In order to assess cognitive and motor dual task ability, the study participant will perform the 'Timed Up and Go Cognitive' subtest from the MiniBESTest (Franchignoni et al, 2010).

Heart rate (HR) will be recorded at rest in supine position during a 5-minute window using a chest belt.

Heart rate variability (HRv) will be recorded at rest in supine position during a 5-minute window using a chest belt.

Determined by the mean of three blood pressure measurements using a sphygmomanometer and a stethoscope.

Measuring daily step count and minutes of daily activity using a wrist-attached wearable device will determine everyday physical acitivity during the training period.

Study participants will rate everyday life quality using the Quality of Life after Brain Injury questionnaire (QOLIBRI; von Steinbuchel, 2010; 36 items originally, adapted to 35 items for stroke, participants rate applicability of statements on quality of life after stroke from not at all to very))

Study participants will rate everyday life cognitive function using the Cognitive Failure Questionnaire (CFQ; Broadbent, 1982; 25 items, participants rate the frequency of situations representing cognitive dysfunction in the past 6 months from very often (4 points) to never (0 points), a lower score represents a better subjective cognitive function).

Mood is measured by the Hospital Anxiety and Depression Scale (HAD-S; Zigmond and Snaith, 1983), which tests for both anxiety and depression in a 14-item questionnaire (7 items each, participants rate statements on a Likert-Scale from 0-3 for each statement, the maximal score is 28 for each domain, the cut-off 11 for anxiety and depression is points or more).

Study participants will rate their degree of apathy using the self-administered Dimensional Apathy Scale (DAS; 24 items; Radakovic and Abrahams, 2014).

Study participants will rate their degree of fatigue on the Modified Fatigue Impact Scale (MFIS; Larson, 2013; 21 items in total, whereof 9 items on a physical subscale, 10 items on a cognitive subscale and 2 items on a psychosocial subscale; every item contains a statement rated on a Likert-Scale from 0-4 (never - almost always), a higher score represents a greater impact of fatigue on the participant's life)

The subjective balance of study participants will be measured using the Tinetti Falls Efficacy scale (Tinetti, 1990), a 10-item questionnaire.

Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients

About this trial

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