Short-term Therapeutic Effects of Functional Electrical Stimulation Device Bioness L300 on the Somatosensory Cortical Representation in the Rehabilitation of Patients After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- SEP measurement
研究概览
简要总结
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.
详细描述
Prediction of motor recovery in the upper-limb (UL) / lower-limb (LL) in patients with stroke is generally based on clinical examination. However, according to former studies neurophysiological measures may also have a predictive value. In the acute phase, the combination of the motor score and SEPs are best predictive of outcome. Neurophysiological measures alone are of limited value in predicting long term outcome. However, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables.
A four-weeks randomized clinical two-period crossover-design study will be conducted. Each patient will be randomized in a two separate consecutive treatment periods (Parallel Group Design). "Group A" will be treated with functional electrical stimulation (FES) and a second "Gruppe B" will be treated without FES for two weeks. After this period Group A and Group B will switched.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Adults between the ages of 18 and 75
- •Inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
- •Medically stable for at least one week following the last episode of stroke
- •Stable medication for four weeks
- •Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback
- •Ability to walk with or without an assistive device (except parallel bars) at least 10 meters
排除标准
- •• Lower motor neuron injury with inadequate response to stimulation
- •History of falls greater than once a week
- •Severe cardiac disease such as myocardial infarction, congestive heart failure, or a demand pacemaker
- •Patients who have other electrical stimulation devices implemented
- •Patients with epilepsy and with autoimmune diseases
结局指标
主要结局
SEP measurement
时间窗: 4 weeks
in improving pathological latencies and / or amplitudes of somatosensory evoked potentials (SEPs) • N35, P40, N50 (lower limb / tibial nerve) amplitude of somatosensory evoked potential \[ Time Frame: Change from baseline at 4 weeks\]
次要结局
- Motor score improvement(4 weeks)
研究者
Prof. Dr. Benedikt Schoser
Senior consultant neurologist
LMU Klinikum