Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
时间窗: 6 weeks
Visuospatial short term memory is measured by the immediate recall of the Brief Visuospatial Memory Test-Revised (BVMT-R; Benedict, 1996)
Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
时间窗: 6 weeks
Divided attention is measured using the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest for divided attention
Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
时间窗: 6 weeks
Cognitive interference is measured using the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan, Kramer, 2001) Stroop Test
Change in subjective executive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)
时间窗: 6 weeks
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))
次要结局
- Change in processing speed after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in cognitive inhibition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in visual working memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Change in cognitive multitasking after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Change in heart rate after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in covert shift of attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(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)(6 weeks)
- Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Everyday physical activity during 6-week training period.(6 weeks)
- Change in apathy after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in everyday life cognitive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in fatigue after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in everyday life quality after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
- Change in subjective balance after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)(6 weeks)
研究者
Prof. Arseny Sokolov, MD, PhD
Professor
Centre Hospitalier Universitaire Vaudois