The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in walking speed
研究概览
简要总结
Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions.
Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All assessors will be blind to intervention
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •>1 year post SCI
- •Non-progressive SCI
- •Neurological level above T10
- •Tolerates upright position for >30 minutes
- •Medically stable (no hospitalizations in last 3 months)
- •Able to comply with procedures and follow up
- •Are legally able to make their own health care decisions
排除标准
- •Progressive SCI/D (MS, ALS, ADEM, etc.)
- •Open wounds at stimulation site
- •Pregnant women
- •ROM limitations impacting gait training
- •Cardiac pacemaker/defibrillator
- •Active cancer diagnosis
- •Currently receiving TSCS
- •Evidence of uncontrolled autonomic dysreflexia
- •Non-English speaking subjects will not be targeted
结局指标
主要结局
Change in walking speed
时间窗: at the start, week 4, and week 8
10-Meter Walk Test
次要结局
- Change in level of assistance and assistive device for walking(at the start, week 4, and week 8)
- Change in walking endurance(at the start, week 4, and week 8)
- Change in walking capacity(at the start, week 4, and week 8)
研究者
Rebecca Martin, OTR/L, OTD
Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.