Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percentage of monopodal stance on the hemiplegic side
研究概览
简要总结
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.
The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.
This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.
详细描述
An inclusion medical exam will occur in order to explain the protocol to the patients, to receive their written informed consent and to check the inclusion and absence of non-inclusion criteria.
The study visit will happen in a 2 weeks' time span at most after the inclusion exam.
During the study visit, the patients will undergo:
-
A quantitative gait analysis with Gait Rite and Optitrack before any intervention;
-
Then, in a randomized order:
-
A vibration stimulation on a non-postural muscle (biceps brachii muscle) in order to get a control stimulation (or "sham") with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped,
-
A vibration stimulation of the posterior neck muscles on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. The precise stimulation location will be located by the pressures centre deviation on a medio-lateral axis on a strength platform (this area can vary for a few centimetres from patient to patient),
-
In order to assess the secondary outcome aiming at defining the best stimulation location, a vibration stimulation of the gluteus medius on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. In the same way than for the neck muscles, the scouting of the precise location will be assessed facing the greater trochanter by the pressures centre deviation on a medio-lateral axis on a strength platform.
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
- •Hemiplegic subjects after stroke:
- •Men or women aged over 18
- •Stroke due to ischemic or haemorrhagic cause
- •More than 6 months after stroke
- •First episode of stroke
- •Gait asymmetry before stimulation
- •Able to walk more than 100 meters with or without cane
- •Written informed consent
排除标准
- •Orthopaedic or rheumatologic disorders impeding the good realisation of the measurement
- •Adults under legal protective regimen or deprived of liberty
结局指标
主要结局
Percentage of monopodal stance on the hemiplegic side
时间窗: Day 0
Improvement of the percentage of monopodal stance on the hemiplegic side during walking after stimulation by vibrations measured by quantitative gait analysis with Gait Rite
次要结局
- Gait parameters on treadmill(Day 0)
- Static posture asymmetry(Day 0)
- Spatio-temporal gait parameters(Day 0)
- Kinematic gait parameters in lower limb(Day 0)