Stabilometric Assessment of Context Dependent Balance Recovery in Persons With Multiple Sclerosis: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change from baseline at three weeks (end of treatment) for the following variables: Length [mm]; Velocity[mm/s]; Sway[mm]
研究概览
简要总结
Background: Balance control relies on accurate perception of visual, somatosensory and vestibular cues. Sensory flow is impaired in Multiple Sclerosis (MS) and little is known about the ability of the sensory systems to adapt after neurological lesions reducing sensory impairment. The aims of the present study were to verify whether:
- Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture
- the improvement in a treated sensory condition would transfer to a non treated sensory condition.
Methods: Fifty three persons with Multiple Sclerosis, median (min-max) Expanded Disability Status Scale score of 5 (2.5-6.5), participated in a Randomized Controlled Trial and were randomly assigned to two groups. The Experimental group received balance rehabilitation aimed at improving motor and sensory strategies. The Control group received rehabilitation treatment which did not include training of sensory strategies. Persons with Multiple Sclerosis were blindly assessed by means of a stabilometric platform with eyes open, eyes closed and dome, on both firm surface and foam. Anterior-posterior and medio-lateral sway, velocity of sway and the length of Center of Pressure (CoP) trajectory were calculated in the six sensory conditions.
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
- Single (Outcomes Assessor)
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
- •Clinically or laboratory definite relapsing-remitting, primary or secondary progressive MS
排除标准
- •Inability to stand independently in upright position for 30 seconds
- •Inability to walk for 6 m even with an assistive device
结局指标
主要结局
Change from baseline at three weeks (end of treatment) for the following variables: Length [mm]; Velocity[mm/s]; Sway[mm]
时间窗: Baseline, 3 weeks (end of treatment)
Multivariate assessment. Length \[mm\]: length of CoP trajectory computed as sum of CoP displacement on the platform surface for each frame; Velocity: velocity of oscillations along anterior-posterior (VelAP) and medio-lateral (VelML) axes. These are computed as the first time derivative of CoP AP and ML displacement. Sway: standard deviation of CoP time series along anterior-posterior (SwayAP) and medio-lateral (SwayML) axes;
次要结局
- Number of falls(baseline, 3 weeks (end of treatment))