Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Average quadriceps power output (watts) measured during 3 minutes of FES cycling
研究概览
简要总结
To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients
详细描述
Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.
Participants will be evaluated before and during the training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Upper Motor Neuron syndrome:
- •adult (> 18 years)
- •motor deficit due to an acquired traumatic or neurodegenerative motor deficiency of the central nervous system (MRC<4/5)
- •stable clinical condition, particularly on the cardiovascular level (recent assessment by a cardiologist with stress test)
- •non denervated muscles
- •tolerant to muscle electrical stimulation
- •having given written consent
- •able to cycle 30 minutes with FES-cycling
排除标准
- •major cognitive comprehension disorders that could compromise understanding of the protocol and the smooth running of the study
- •cardiac pacemaker and other contraindications relating to the use of electrostimulation (in particularly "deep vein thrombosis")
- •spasticity of the lower limbs making flexion/extension movement difficult
- •participation in another study
- •pregnancy
- •people with the following legal and administrative states or situations:
- •people placed under judicial protection;
- •persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation;
- •unemancipated minors;
- •people who are not affiliated to a social security scheme or beneficiaries of such a scheme
结局指标
主要结局
Average quadriceps power output (watts) measured during 3 minutes of FES cycling
时间窗: during sessions of FES cycling
The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS\_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated.
Average quadriceps power output (watts) measured during 3 minutes of FES cycling
时间窗: during sessions of FES cycling
The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS\_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated.
次要结局
- Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes(before the first session of FES cycling)