Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Fugl-Meyer upper extremity scale
研究概览
简要总结
Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.
详细描述
This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity [FMA-UE], Brunnstr¨om stage [B-stage] for the arm and the hand, manual muscle testing [MMT], modified Barthel index [MBI], EuroQol-5 Dimension [EQ-5D], and Beck Depression Inventory [BDI]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic or hemorrhagic stroke confirmed by brain imaging study
- •upper extremity dysfunction
- •possible to use a simple device
排除标准
- •delirium, confusion or other evidence related to the consciousness
- •uncontrolled medical or surgical disease
- •unable to command to the order due to severe cognitive impairment
- •visual impairment
- •unable to sit
研究组 & 干预措施
Virtual reality program
mobile device for virtual reality program
干预措施: Virtual reality program for upper extremity rehabilitation (Other)
Control
standard occupuational therapy
干预措施: standard occupational therapy (Other)
结局指标
主要结局
Fugl-Meyer upper extremity scale
时间窗: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
for motor evaluation
次要结局
- brunnström stage(baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks)
- Modified Barthel Index(baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks)
- questionnaire(at the end of the treatment for 2 weeks)
- Euroqol(EQ)-5D(baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks)
- Virtual reality kinematic data(everytime when the patient uses program (automatically all recorded))
- Medical Research Council (MRC) Scale for Muscle Strength(baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital