Evaluation of the Increase of the Driving Speed After the Apparatus by Walkaide® Medical Device in Deficits Levator Foot of Central Origin.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in walking speed
研究概览
简要总结
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.
详细描述
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotic and walking with orthotic Walkaide® medical devie after one month of training.
This is a prospective multicenter study, without control group, qualified as a biomedical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Passive ankle dorsiflexion of at least 0 ° (strained knee)
- •No injection of botulinum toxin in the lower limbs for at months 3 months
- •No surgery for at least three months
- •Walk 10 meters in less than 60 seconds, without human help, with or without technical assistance
- •Score the Functional Ambulation Classification (FAC) ≥ 3
- •Ashworth Score ≤ 2 sural triceps
- •Written consent signed
排除标准
- •Presence of severe cognitive impairment that does not allow the use of the device independently
- •History of debilitating disease associated general
- •Local embarrassing skin disorder laying the electrodes
- •Pacemaker
- •Unstable Epilepsy
- •Pregnancy and lactation
- •Participation Refusal
研究组 & 干预措施
WALKAIDE
A clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device.
Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device.
干预措施: WALKAIDE (Device)
结局指标
主要结局
Change in walking speed
时间窗: One month
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotics and walking with Walkaide® functionnal electric stimulation orthosis after one month of training.
次要结局
未报告次要终点