Effects of FES-cycling in Patients With Hemiparesis After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- VO2 peak at 2 months (L/min)
研究概览
简要总结
To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis
详细描述
Design: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.
Setting: Neurologic Rehabilitation Unit Interventions: 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).
In addition to the assigned group treatment, subjects will perform their own standard rehabilitation program.
Participants will be evaluated before training, after training, and at 3 month follow-up visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Sham stimulation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with Hemiparesis after an unilateral first ever stroke
- •Able to walk in security
- •Time since stroke within 3 months to 1 year
- •Sufficient cognitive function to understand and perform corresponding tasks
排除标准
- •Any history of neurological disorders or cardiovascular instability
- •High spasticity on ankle, knee, hip muscles
- •Inability to exercise on a cyclo-ergometer
- •Pacemaker and other contraindications of the use of electrical stimulation
结局指标
主要结局
VO2 peak at 2 months (L/min)
时间窗: From enrollment to the end of treatment at 8 weeks
Comparison of the maximum oxygen consumption (VO2 peak in L/min) measured during an incremental maximum stress test on cyclo-ergometer between the end of training (M2) and inclusion (M0).
次要结局
- Cognitive function(2 months)
- Maximum power(2 months)
- Walking ability(4 months)
- quadriceps muscular thickness(2 months)
- Middle Cerebral Artery Blood Flow Velocity During Exercise(2 months)