PEMOCS: Effects of a Concept-guided, PErsonalized, MOtor-Cognitive Training in Chronic Stroke - a RCT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- Change of Montreal Cognitive Assessment Score
研究概览
简要总结
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.
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
- Single (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
- •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
排除标准
- •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
结局指标
主要结局
Change of Montreal Cognitive Assessment Score
时间窗: week 0, week 12 and week 24
Widely used screening tool and cognitive outcome in neurological patients including stroke
次要结局
- Change of Stroop Interference Test Parameters(week 0, week 12 and week 24)
- Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs(week 0, week 12 and week 24)
- Change of 10 meter walk test Gait Parameters(week 0, week 12 and week 24)
- Change of N-back test Parameters(week 0, week 12 and week 24)
- Change of Stroke Impact Scale 3.0 Score(week 0, week 12 and week 24)
- Change of Simple Reaction Test Parameters(week 0, week 12 and week 24)
- Change of Trail Making Test A & B Parameters(week 0, week 12 and week 24)
- Change of Mental Rotation Test Parameters(week 0, week 12 and week 24)
- Change of Outdoor Gait Parameters(week 0, week 12 and week 24)