Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- score of Fugl Meyer Assessment (lower limbs)
研究概览
简要总结
In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.
In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.
The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).
- •Responsible for a motor deficit in the right or left lower limb.
- •No neurological history other than stroke.
排除标准
- •Multifocal stroke
- •Patient having received a botulinum toxin injection to the lower limb to be vibrated
结局指标
主要结局
score of Fugl Meyer Assessment (lower limbs)
时间窗: day 30
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
次要结局
- assess functional walking ability(day 0, day 15, day 30 and month 2)
- score of Fugl Meyer Assessment (lower limbs)(day 0, day 15, day 30 and month 2)
- score of Medical Research Concil(day 0, day 15, day 30 and month 2)
- score of postural assessment scale for stroke(day 0, day 15, day 30 and month 2)
- analysis of static equilibrium(day 0, day 15, day 30 and month 2)
- positional measurement of the center of gravity(day 0, day 15, day 30 and month 2)