Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change of Jebsen Taylor test
研究概览
简要总结
The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. The aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.
详细描述
Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20
- •9-hole pegboard ; ≥ 25% of contra-lateral hand
排除标准
- •Alexander apraxia scale ≤2
- •NIH stroke scale question Ia-c ≥1
- •Nottingham sensory scale; <75% of contra-lateral hand
- •Ashworth scale ≥3
- •NIH stroke scale question IX ≥2
- •Beck depression inventory ≥21
- •Significant upper extremity disease causing hand or below elbow dysfunction
- •Visual disturbance
- •Refusal of participation
研究组 & 干预措施
Enhanced reality
Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks.
干预措施: Enhanced reality (Device)
No Enhanced reality
Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
干预措施: No Enhanced reality (Other)
结局指标
主要结局
Change of Jebsen Taylor test
时间窗: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Jebsen-Taylor Hand Function Test
次要结局
- Change of Arm motor Fugl-Mayer scale(1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment)
研究者
Chang Ho Hwang
Principal Investigator
Ulsan University Hospital