Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Aerobic Fitness
研究概览
简要总结
The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short [HI-SHORT] and low-long [LO-LONG]. Both groups (n=10 per group) will exercise on the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). [HI-SHORT] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. [LO-LONG] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for [HI-SHORT] and [LO-LONG] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 6-weeks post-trauma after SCI.
- •Traumatic and atraumatic spinal cord injuries between C7 and T10
- •Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B.
- •Age between 18-75 years old.
- •Both male and female.
- •Have at least 90º bilateral knee flexion.
- •Able to perform FES muscle contractions (not FES intolerant).
- •Able to follow verbal instructions.
排除标准
- •A recent history of trauma to the lower limb.
- •Severe or infected pressure sore on weight-bearing skin areas.
- •Illness caused by acute urinary tract infection.
- •Uncontrolled spasticity or pain.
- •History of cardiovascular / cardiorespiratory disease contraindicating exercise.
- •Uncontrolled orthostatic hypotension.
- •Unhealed decubiti at electrode placement area.
- •Recurrent and uncontrolled autonomic dysreflexia.
- •Active heterotopic ossification.
- •Other peripheral or central neurologic injury.
结局指标
主要结局
Aerobic Fitness
时间窗: Day 0 to 6 weeks
Change of Peak Oxygen Uptake - VO2peak (L/min)
次要结局
- Muscle Near Infrared Spectroscopy(Day 0 to 6 Weeks)
- Strength Fitness(Day 0 to 6 weeks)