Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Gait Speed
研究概览
简要总结
Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least six months since the onset of Ischemic or hemorrhagic stroke.
- •Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score < 34).
- •Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
- •Can walk at least 10 feet with and without assistive device.
- •Functional Gait Assessment score <22.
排除标准
- •Pre-existing neurological disorders.
- •Previous stroke affecting the other hemisphere .
- •Severe arthritis or orthopedic problems that limit passive range of motion.
- •Areas of recent bleeding or open wounds.
- •Lack normal sensation on the tongue.
- •Received treatment for cancer within the past year.
- •Non-removable metal orthodontic devices.
- •Oral health problems.
- •Are sensitive to nickel, gold or copper.
- •Chronic infectious diseases.
- •Are pregnant.
- •Have dementia
研究组 & 干预措施
Sham
干预措施: Sham (Device)
Portable Neuromodulation Stimulator
干预措施: Portable Neuromodulation Stimulation (Device)
Portable Neuromodulation Stimulator
干预措施: Gait and balance training (Other)
Sham
干预措施: Gait and balance training (Other)
结局指标
主要结局
Change in Gait Speed
时间窗: Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks
Self-selected comfortable walking overground walking speed in cm/s.
Change in Balance
时间窗: Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks
Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.
次要结局
未报告次要终点
研究者
Steven Kautz
Depertment Chair
Medical University of South Carolina