Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients

Официальное название

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

Обзор

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)

Подробное описание

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.

Вмешательства

• Устройство Computerized Gaming Rehabilitation Program 1
  Brain training games with physical exercise component.
• Устройство Computerized Gaming Rehabilitation Program 2
  Cognitive training games with physical exercise component.

Первичные конечные точки

• Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in subjective executive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Change in visual working memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in processing speed after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• 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) [Срок оценки: 6 weeks]
• 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) [Срок оценки: 6 weeks]
• Change in cognitive inhibition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in cognitive multitasking after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in covert shift of attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in risk of falls and postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]
• 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) [Срок оценки: 6 weeks]
• Change in heart rate after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Lausanne University Hospital (CHUV) — Lausanne

Публикации

• Zimmermann, P. and B. Fimm, A test battery for attentional performance. Applied Neuropsychology of Attention, Theory, Diagnosis and Rehabilitation 2002: p. 110-151.
• Benedict, R.H.B., et al., Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and Validity. Psychological Assessment, 1996.
• Delis DC, Kramer JH, Kaplan E, Holdnack J. Reliability and validity of the Delis-Kaplan Executive Function System: an update. J Int Neuropsychol Soc. 2004 Mar;10(2):301-3. doi: 10.1017/S1355617704102191. No abstract available. PMID 15012851
• Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27. PMID 22537095
• Vogel EK, McCollough AW, Machizawa MG. Neural measures reveal individual differences in controlling access to working memory. Nature. 2005 Nov 24;438(7067):500-3. doi: 10.1038/nature04171. PMID 16306992
• Regard M, Strauss E, Knapp P. Children's production on verbal and non-verbal fluency tasks. Percept Mot Skills. 1982 Dec;55(3 Pt 1):839-44. doi: 10.2466/pms.1982.55.3.839. No abstract available. PMID 7162920
• REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available. PMID 13263471
• Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469. PMID 12422327

Идентификаторы

NCT: NCT05169632 · CHUV-DNC-CCT-STROKE-2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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