Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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MI
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Milan、MI、意大利、20132
- IRCSS Ospedale San Raffaele
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Acquired Brain Injury within 1 month before the recruitment;
- Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);
- Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.
Exclusion Criteria:
- Denial of informed consent;
- Visual deficits that interfere with the virtual reality rehabilitation;
- Score under 18 at the Mini Mental State Examination;
- Severe orthopedic deficit;
- Patients with pace maker;
- Patients with contraindication to undergo magnetic resonance;
- Pregnant women.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Virtual Reality rehabilitation group
The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.
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Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: virtual reality upper extremity motor rehabilitation 1 hour: virtual reality neurocognitive training |
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有源比较器：Control group
The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.
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Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: upper extremity motor rehabilitation 1 hour: neurocognitive training |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Fugl-Meyer Upper Extremity (FMUE)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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Items are scored on a 3-point ordinal scale 0 = cannot perform; 1 = performs partially; 2 = performs fully. Maximum Score = 66 points |
From Baseline (T0) to 3 weeks of rehabilitation (T1)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in Action Research Arm Test (ARAT)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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Change in Functional Independence Measures (FIM)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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Change in Mini Mental State Examination (MMSE)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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Change in Montreal Cognitive Assessment (MoCA)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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Change in Beck Depression Inventory (BDI)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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Change in 36-Item Short Form Survey (SF-36)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Change in Resting state functional MRI (fMRI)
大体时间：From Baseline (T0) to 3 weeks of rehabilitation (T1)
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From Baseline (T0) to 3 weeks of rehabilitation (T1)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Virtual Reality rehabilitation group的临床试验
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IRCCS Eugenio Medea招聘中
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Southern Methodist UniversityKing's College London完全的
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MetroHealth Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; MetroHealth System...尚未招聘