Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Measurement of walking speed at 3 months
研究概览
简要总结
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.
The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.
详细描述
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEPPAGE foot walking in a patient with a central neurological disease
- •can walk for 50 meters with or without technical assistance
- •stable disease for at least 1 year
- •possible walk with a brace-type reliever
- •verification of possible nerve stimulation
- •age greater than or equal to 18 years and under 75 years
- •no toxin for 4 months
- •no alcohol for 6 months
- •no neurotomy for 1 year
- •patient who agreed to sign an informed consent to participate in the study
排除标准
- •cons-indication to general anesthesia
- •wearing a stimulator implanted for other reasons
- •patients taking neuroleptics, benzodiazepines, or antidepressants or other drugs that interfere with the quality of walking
- •advanced peripheral neuropathy
- •excessive restriction of passive range of ankle
- •poorly controlled epilepsy
- •pregnant or lactating
- •non-membership of a social security scheme
- •wearing orthopaedic shoes including the malleolus
结局指标
主要结局
Measurement of walking speed at 3 months
时间窗: Measurement will be performed at 3 months
The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement
Measurement of walking speed at 6 months
时间窗: Measurement will be performed at 6 months
The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement
次要结局
未报告次要终点