Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Patients With Neurological Disorders (FES-ROW)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- VO2 peak at 6 months (L/min)
研究概览
简要总结
The main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia.
详细描述
Beyond the inability to walk, chronic paraplegic patients show an increase in their mortality from cardiovascular pathologies, compared to the same age groups of the general population. It is the hypoactivity induced by neurological impairment that is implicated in the first place in the pathogenesis of these abnormalities. The search for training methods adapted to these patients is justified to limit cardiovascular morbidity and mortality.
The aim of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with stabilized paraplegia (non-walkers), of traumatic origin.
Study is divided in two 3-month phases. The first consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs only for a period of 3 months at the rate of 3 sessions of 30 minutes per week. The second consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs and upper for a period of 3 months at the rate of 3 sessions of 30 minutes per week. The evaluations are composed of the measurement of maximum oxygen consumption, muscle and neurological parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paraplegia with traumatic origin
- •Spinal cord injury AIS (ASIA Impairment Scale) score A and B at least 12 months old
- •Patient having given written consent
- •Patient with social security scheme
- •Ability to obtain a leg extension with a 30-minute electrostimulation program
排除标准
- •Protected adults (person in guardianship, curators or legal protection)
- •Presence of contraindication criteria to carrying out a stress test or sustained physical activity decided by the doctor following the person with spinal cord injury.
- •Drug treatment with cardiovascular or antidepressant effect
- •Pressure sore
- •Other associated neurological pathologies (stroke, peripheral neuropathy, myopathy, head trauma, ...)
- •Affection of the shoulders of any etiology that could compromise the ability to use the rower.
- •Spasticity of the lower limbs: Modified Ashworth Scale (MAS) greater than or equal to 2/4 (specifically quadriceps / Hamstrings)
- •Participation in another study
结局指标
主要结局
VO2 peak at 6 months (L/min)
时间窗: 6 months
Comparison of the maximum oxygen consumption (VO2 peak in L/min) measured during an incremental maximum stress test on a hand ergometer between the end of training on a rower (M6) and inclusion (M0).
次要结局
- VO2 peak at 3 and 9 months (L/min)(9 months)
- Response to stimulation at 0, 3, 6 and 9 months (mA)(9 months)
- Intensity of osteotendinous reflexes at 0, 3, 6 and 9 months(9 months)
- Maximum electro-induced force at 0, 3, 6 and 9 months (Nm)(9 months)
- Assessment of spasticity at 0, 3, 6 and 9 months(9 months)
- ASIA (American Spinal Injury Association) score at 0, 6 and 9 months(9 months)
- Self-assessment at 0, 3, 6 and 9 months(9 months)
- First ventilatory threshold in the VO2max test at 0, 3, 6 and 9 months (L/min)(9 months)
- Thigh perimeter at 0, 3, 6 and 9 months (cm)(9 months)
- Maximum power at 0, 3, 6 and 9 months (Watts)(9 months)