High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Body Weight Supported Treadmill Training (BWSTT) After Stroke: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in Walking Speed
研究概览
简要总结
The study will enroll 5 individuals post-stroke to examine the feasibility and efficacy of a high frequency repetitive transcranial magnetic stimulation (rTMS) combined with body weight supported treadmill training.
详细描述
The purpose of this pilot study is to examine the feasibility and efficacy of 5Hz repetitive transcranial magnetic stimulation (rTMS) applied to bilateral motor areas as an adjuvant intervention to task-specific body weight supported treadmill training (BWSTT) in individuals with subacute stroke.
Five individuals with a diagnosis of subacute stroke will be recruited and assigned to either high frequency or sham rTMS group.Both groups will receive a comprehensive assessment of their motor function, gait performance and neurophysiological function before the training. Both groups will then go through a 10 week (24 sessions) of gait training with body weight supported treadmill. For the high frequency rTMS group, they will receive 5 Hz rTMS applied to bilateral motor areas prior to each gait training session. For the sham rTMS group, they will receive a sham stimulation prior to the gait training sessions. All participants will receive another comprehensive assessment after the training concludes. The assessor will be blinded to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •< 2 months post stroke at the time of enrollment
- •first time stroke:
- •able to walk > 25 feet with or without assistive device and with no more than moderate assistance:
- •able to follow 1-step commands
- •able to communicate verbally
排除标准
- •severe medical problems (e.g. recent cardiac infarct, heart failure, cancer)
- •presence of conditions that could affect gait training (e.g. amputation, severe arthritis)
- •bilateral stroke
- •non-ambulatory prior to stroke
- •any contraindications to TMS (e.g. history of seizure, cardiac pacemaker, metal or magnetic implants)
- •pregnant or potentially to be pregnant
结局指标
主要结局
Change in Walking Speed
时间窗: 10 weeks
Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance.
次要结局
- Change in Cortical Excitability(10 weeks)
- Change in Quality of Life(10 weeks)
- Change in Motor Function(10 weeks)
- Change in Walking Endurance(10 weeks)
研究者
Hui Ting Goh
Assistant Professor
Texas Woman's University