Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Upper Extremity (FMUE)
研究概览
简要总结
The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Virtual Reality rehabilitation group
The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.
干预措施: Virtual Reality rehabilitation group (Other)
Control group
The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.
干预措施: Control group rehabilitation (Other)
结局指标
主要结局
Change in Fugl-Meyer Upper Extremity (FMUE)
时间窗: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Items are scored on a 3-point ordinal scale 0 = cannot perform; 1 = performs partially; 2 = performs fully. Maximum Score = 66 points
次要结局
- Change in Functional Independence Measures (FIM)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
- Change in Beck Depression Inventory (BDI)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
- Change in Action Research Arm Test (ARAT)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
- Change in Mini Mental State Examination (MMSE)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
- Change in Montreal Cognitive Assessment (MoCA)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
- Change in 36-Item Short Form Survey (SF-36)(From Baseline (T0) to 3 weeks of rehabilitation (T1))
研究者
Sandro Iannaccone
Head of Neuro Rehabilitation Unit, Principal Investigator
IRCCS San Raffaele