NCT00692523已完成不适用
A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary feasibility outcome is the total time receiving the intervention.
研究概览
简要总结
This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual gaming system is safe and feasible for use in patients who have had a recent stroke.
详细描述
A pilot, randomized (1:1) controlled trial to compare the safety and feasibility of Nintendo Wii gaming versus other recreational therapy activities (playing cards) in post-stroke patients. All patients will continue to receive all other standard medical and physiotherapy treatments while in the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided written informed consent prior to entry into the study
- •In-patient at one of the two study institutions at the time of randomization
- •Males or females, aged over 18 and younger than 85
- •Evidence of stroke confirmed by CT head (ischemic or hemorrhagic)
- •Time: Onset of symptoms within 6 months prior to randomization
- •Measurable Chedoke-McMaster scale stage of =>4 on the "arm" item (10)
- •Functional independence prior to present stroke (baseline mRS = 0-1)
- •Patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
排除标准
- •Acute stroke onset more than 6 months ago
- •Patient is unable to follow verbal commands or has global aphasia
- •Severe illness with life expectancy less than 3 months (cancer, endocarditis, metastasis with an occult primary malignancy, coagulopathy).
- •Uncontrolled hypertension according to the treating physician
- •Unstable angina or recent myocardial infarction (within the last 3 months), current NY Heart Association Class III (marked limitation of physical activity; although patients are comfortable at rest, less-than-ordinary activity leads to fatigue, dyspnea, palpitations, or angina3) or IV (symptomatic at rest; symptoms of CHF are present at rest; discomfort increases with any physical activity) or symptomatic ventricular tachyarrhythmias, as per medical history (a baseline ECG will not be required.)
- •Any history of seizure, except for febrile seizures of childhood
- •Participation in another clinical trial involving rehabilitation (recreational therapy, occupational therapy, physiotherapy) or involving an investigational drug.
- •Patient is unwilling or unable to comply with the protocol or can not/will not cooperate fully with the investigator or study personnel.
- •Any condition(s) that, in the Investigator's opinion, would a) warrant exclusion from the study (i.e., participation in the study is not in the best interest of the patient) or b) prevent the patient from completing the study.
- •Any medical condition that might confound the interpretation of results or put the patient at risk (amputation of one extremity).
结局指标
主要结局
The primary feasibility outcome is the total time receiving the intervention.
时间窗: 2 weeks
The primary safety outcome is the proportion of patients experiencing intervention-related adverse events, or any serious adverse event during the study period.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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