NCT02772510Unknown不适用
Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment-hand & wrist
研究概览
简要总结
The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-ever ischemic or hemorrhagic stroke
- •wrist extensor of medical research council scale 1~3
- •No clinical evidence of limited passive range of motion of affected wrist
排除标准
- •age <18 years
- •severe aphasia resulting in communication difficulties confounding intervention and outcome measures
- •severe cognitive impairment resulting cooperation difficulties
- •spasticity > modified Ashworth scale 1+
结局指标
主要结局
Fugl-Meyer Assessment-hand & wrist
时间窗: 4 weeks from baseline
Wolf Motor Function Test
时间窗: 4 weeks from baseline
次要结局
- Box and Block Test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Stroke Impact Scale(baseline, 4 weeks after baseline)
- Range Of Motion of wrist flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Modified Ashworth scale of wrist flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Adverse events(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Wolf Motor Function Test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Brunnstrom stage(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Fugl-Meyer Assessment upper extremity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Motor Activity Log(baseline, 4 weeks after baseline)
- Medical research council scale of elbow flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Medical research council scale of wrist flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Range Of Motion of elbow flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Modified Ashworth scale of elbow flexor/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Modified Tardieu scale of elbow flexor/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Modified Tardieu scale of wrist flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Jebsen-Taylor hand function test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
研究者
Joon-Ho Shin
Manager
National Rehabilitation Center, Seoul, Korea
研究点 (2)
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