Electrical Stimulation Induced Lower Limb Exercise Capacity, Cardiorespiratory Response, Cardiovascular Risk Factors and Muscle Activity Patterns in Response to Robotic Assisted Treadmill Gait Training in Individuals With Complete Motor Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Electrical stimulation induced lower limb exercise capacity in individuals with SCI
研究概览
简要总结
The purpose of this study is to determine whether a three times per week, 2 month robotic assisted treadmill gait training program, will beneficially affect the fitness, physical and psychological well-being, and the vascular and metabolic cardiovascular risk factors in individuals with complete motor Spinal Cord Injury (SCI).
详细描述
Cardiovascular morbidity and mortality are a source of increasing concern among people with SCI and their health providers. The importance of physical activity in reducing the risk of heart disease in this population is indisputable, but exercise opportunities for persons with SCI are limited by physiologic and functional factors. Decreased functional muscle mass, impaired autonomic control of myocardial function, and decreased venous return limits training responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant non-lactating female
- •At least 6 months after injury
- •Complete (AIS A-B) cervical (C4-8) or thoracic (T1-T6) spinal cord injury according to American Spinal Injury Association (AIS) guidelines.
- •Under 100 kg and between 155 - 200 cm of height
排除标准
- •History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc).
- •Severe concurrent medical diseases: infections, heart or lung, pressure sores, etc
- •Unstable spine or unhealed limbs or pelvic fractures
- •Psychiatric or cognitive situations that may interfere with the trial
- •Spasticity above 3 degree according to Ashworth scale
- •Reduced range of motion of knee/hip > 15°
研究组 & 干预措施
study arm
干预措施: LOKOMAT (Device)
结局指标
主要结局
Electrical stimulation induced lower limb exercise capacity in individuals with SCI
时间窗: 4 and 8 weeks of training
The lower limb exercise capacity in response to electrical stimulation will be measured by the use of the ERGYS II system
次要结局
- Reduction of risk factors for CVD(4 and 8 weeks)
研究者
Dr. Gabriel Zeilig
Dr. Gabriel Zeilig
Sheba Medical Center