Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Change from Baseline Kunming Locomotor Scale (KLS) at 6 months
研究概览
简要总结
Spinal cord injury (SCI) is a common and severe traumatic central nervous system injury in clinical practice. Currently, the treatment of SCI remains a worldwide challenge.International studies have confirmed that TSCS is an effective non-invasive technique to activate the body's movement-related circuits. This method utilizes a unique stimulation waveform that is transmitted through electrodes placed on the skin of the spine and spreads through the dorsal roots (DRs) to activate the spinal cord neural circuits.The main objective of this study is to have patients with chronic incomplete (AIS B/C/D) spinal cord injuries wear "transcutaneous spinal cord electrical stimulator " and undergo "Kunming locomotor training" for 6 months, observe the synergistic effects of the two, and evaluate whether this treatment method can improve patients' motor functions.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;
- •2.Subjects must be able to read, understand, and complete the Visual Analogue Scale;
- •3.Subjects voluntarily sign the informed consent form approved by the ethics committee.
排除标准
- •Obvious renal, cardiovascular, hepatic, and mental diseases;
- •2.Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
- •Limb contracture deformity;
- •Modified Ashworth > Grade 2;
- •Unhealed fractures;
- •The subject is currently participating in other studies;
- •The researcher's opinion is that the subject does not comply with the research protocol and/or is not suitable to participate in this study.
结局指标
主要结局
Change from Baseline Kunming Locomotor Scale (KLS) at 6 months
时间窗: Day 0, Month 6
Scale from minimum (1) to maximum (10), higher scales mean a better outcome.
Change from Baseline 10 Meter Walk Test (10mWT) at 6 months
时间窗: Day 0, Month 6
The primary measure obtained from the test is the walking speed, which is calculated by dividing the distance by the time taken to complete the walk.
次要结局
- Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months(Day 0, Month 6)
- Change from Lower extremity motor score(LEMS) at 6 months(Day 0, Month 6)
研究者
Hui Zhu
Director
Kunming Tongren Hospital