Effect of Visual Feedback Balance Training System Combined with Repetitive Facilitative Exercise on Fall Risk After Stroke: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Deviation of bilateral center of gravity movement area
研究概览
简要总结
The goal of this clinical trial is to learn if visual feedback balance training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:
Does visual feedback balance training system combined with RFE reduce the fall risk of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?
Researchers will compare 3 groups (RFE, visual feedback balance training system under RFE, and conventional therapy) to see if visual feedback balance training system and RFE works to treat stroke.
Participants will:
Receive treatment for 4 weeks Receive scale and instrument testing before and after 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 (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (18 to 74 years old) who suffered a first or second unilateral stroke
- •chronic stroke (over 6 months from the onset)
- •moderate or higher risk of falls (TUG > 15s, or 10-MWT ≤ 0.8m/s)
- •ability to understand and follow simple directions
排除标准
- •pregnant or lactating
- •lower extremity contracture, pain, or trauma
- •perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
- •unable to maintain standing posture
- •cerebellar lesion
- •clinically unstable medical disorders
- •inability to provide informed consent
结局指标
主要结局
Deviation of bilateral center of gravity movement area
时间窗: From enrollment to the end of treatment at 4 weeks
Use the Libra parameters evaluation system included with visual feedback balance training system
time up and go test (TUG)
时间窗: From enrollment to the end of treatment at 4 weeks
10-meter walk test (10-MWT)
时间窗: From enrollment to the end of treatment at 4 weeks
Center of gravity loss index
时间窗: From enrollment to the end of treatment at 4 weeks
Use the Libra parameters evaluation system included with visual feedback balance training system
次要结局
- Fugl-Meyer Assessment (FMA)(From enrollment to the end of treatment at 4 weeks)
- functional ambulation category scale (FAC)(From enrollment to the end of treatment at 4 weeks)
- Berg balance scale (BBS)(From enrollment to the end of treatment at 4 weeks)
研究者
Jingzhi Zhang
therapist-in-charge
Nanjing Mingzhou Rehabilitation Hospital