Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Metabolic function testing
研究概览
简要总结
Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.
This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.
详细描述
This project will evaluate the effects of non-invasive lumbar ts-ES on locomotor function in people with incomplete motor SCI (iSCI) who retain some ability to stand or walk.
This study has 3 phases:
Baseline assessment - 2 sessions - week 1 -Lab visits #1-2
Locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)
End of training assessment - 2 sessions - week 6- Lab visits #15-16.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has spinal cord injury, 6 mo or longer since injury
- •Is between 20 and 65 years of age
- •Has difficulty with trunk and/or lower limb function
- •Stable medical condition
- •Non-progressive etiology of spinal injury
- •No ventilatory support
排除标准
- •Genetic or degenerative etiology of spinal injury
- •Need for ventilatory or other life-sustaining medical support
- •History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)
研究组 & 干预措施
Treadmill training combined with muscle and spinal cord stimulation
Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating.
干预措施: Trans-spinal electrical stimulation (Device)
Treadmill training combined with muscle and spinal cord stimulation
Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating.
干预措施: Electrical muscle activation (Device)
Treadmill training combined with muscle and spinal cord stimulation
Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating.
干预措施: Treadmill walking (Other)
结局指标
主要结局
Metabolic function testing
时间窗: Pre-training (on week 1) and within one week from end of training (on week 6)
Breath-by-breath analysis of air in/out will be used to measure VO2max (mL/kg/min).
Electromyography (EMG) of ankle extensor muscles
时间窗: Pre-training (on week 1) and within one week from end of training (on week 6)
Mean RMS amplitude
Neurophysiological markers or stepping
时间窗: Pre-training (on week 1) and within one week from end of training (on week 6)
Average step length, step height at ankle (cm).
次要结局
- 6 Min Walk Test(Pre-training (on week 1) and within one week from end of training (on week 6))
- Rate or Perceived Exertion (RPE) of Submaximal VO2 testing(Pre-training (on week 1) and within one week from end of training (on week 6))
- SCIM-Spinal Cord Independence Measure- Mobility scores(Pre-training (on week 1) and within one week from end of training (on week 6))
- Autonomic scores(Pre-training (on week 1) and within one week from end of training (on week 6))
研究者
Katinka Stecina
Associate Professor
University of Manitoba