Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in knee joint extensors peak torque (Newton-Meters)
研究概览
简要总结
Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury, brain injury or acquired muscle weakness
- •Managed chronic diseases
- •No contraindications to the practice of physical exercise
- •Ability to communicate in oral and written Portuguese
排除标准
- •Amputation of lower limbs at any level
- •Unstable or acute fractures of lower limbs
- •Contraindication for the practice of physical activity
- •Open wounds in the lower limbs
- •Consent withdraw
结局指标
主要结局
Change in knee joint extensors peak torque (Newton-Meters)
时间窗: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change in knee joint flexors peak torque (Newton-Meters)
时间窗: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change in thigh perimeter (centimeters)
时间窗: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
Quadriceps muscle integrity, measured by thigh volumetry
Change in rectus femoris thickness (centimeters)
时间窗: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
Rectus femoris muscle structural integrity, measured by ultrasound
Change in vastus intermedius thickness (centimeters)
时间窗: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation
Vastus intermedius muscle structural integrity, measured by ultrasound
次要结局
- System Usability Score(System usability at end of intervention, completed 8 weeks after initiation)
- Adverse effects inventory(Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation)
- Patients Perception of Treatment Outcomes Score(Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation)