Distal Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation (tDCS) for Stroke Patients : a Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Box and block test
研究概览
简要总结
The aim of this study to investigate the effect of combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. We hypothesized that experimental group (VR-based training with dual-tDCS) would improve distal upper extremity function rather than control group (VR-based training with dual sham tDCS).
详细描述
This is a double-blind, randomized controlled study. Patients were randomly assigned to 1 : 1 ratio to experimental group (VR-based training with dual-tDCS; VR-Dual) or the control group (VR-based training with dual sham tDCS; VR-Sham) . For both conditions, VR-Dual and VR-Sham group commenced at the same time (20 minutes). The therapist and patients were blinded as to whether the patients received real or sham tDCS. The study was approved by the Ethics Committee of the National Rehabilitation Center, Korea, and all participants provided written informed consent before enrollment.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-time ischemic or hemorrhagic stroke
- •unilateral upper extremity functional deficits after stroke
- •presence of a score of at least 3 points on the Medical Research Council (MRC)
- •a score ≥ 4 on the Brunnstrom stage
- •a score ≥ 25 on the Korean version of the Mini-Mental Status Exam (K-MMSE)
排除标准
- •age < 20 years
- •wrist and finger spasticity with the Modified Ashworth Scale (MAS) score ≥ 2
- •uncontrolled hypertension, heart problems, infection, or any history of seizure or epilepsy
- •neurological disorders that cause motor deficits
- •being unable to perform the task or to understand instructions
- •presence of pacemaker, pregnancy, cognitive impairment, or psychiatric disorders
研究组 & 干预措施
SMART Glove system with dual-tDCS
VR-based SMART Glove system with dual-tDCS
干预措施: SMART Glove system with tDCS (Device)
SMART Glove system with sham-tDCS
VR-based SMART Glove system with sham-tDCS
干预措施: SMART Glove system with sham-tDCS (Device)
结局指标
主要结局
Box and block test
时间窗: baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
Change of box and block test scores
次要结局
- Jebsen Taylor Hand Function Test (JTT)(baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3))
- Stroke Impact Scale (SIS)(pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2))
- Fugl-Meyer assessment of the upper extremity (FMA)(baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3))
- Grip strength(baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3))
研究者
Joon-Ho Shin
Team manager
National Rehabilitation Center, Seoul, Korea