Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Clinical Scale for Contraversive Pushing
研究概览
简要总结
The purpose of this study is to investigate the effects of vibration stimuli to contra lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke patients.
详细描述
12 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Raanana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 2 weeks intervention (10 sessions) in each group will include vibration stimuli (frequency of 1 Hz and amplitude of 20 mm) for 20 minutes and structured standard physiotherapy for 45 minutes. The vibration stimuli in the experimental group will be done to the contralesional neck muscles, whereas the vibration stimuli in the control group will be done in the contralesional hand. Different assessments will be done before the intervention, after the first day of intervention, after two weeks of intervention and one months post-intervention. The tests will include: Clinical Scale for Contraversive Pushing, Lateropulsion Scale, Subjective Straight Ahead, Postural Assesment Scale for Stroke Patients, Anterior and Lateral Functional Reach Test, Posturography, Behavioral Inattention Test, Mesulam Cancellation Test, Line Bisection Test, Dynamic Starry Night and sensation.
Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons. Smallest Real Difference (SRD) will be calculated for detecting the minimal detectable change.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First stroke
- •Age 25-75 years
- •Able to understand research instructions
- •Stable clinical/metabolic state.
- •Having Contraversive Pushing Syndrome, based on Clinical Scale for Contraversive Pushing.
排除标准
- •Having previous neurological and orthopedic disability.
- •Having pacemakers.
结局指标
主要结局
Change in Clinical Scale for Contraversive Pushing
时间窗: Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up)
Score range: 0-6. Score of zero indicates no pushing. Assesses pushing during spontaneous body posture, abduction and extension of the nonparetic extremities and resistance to passive correction of tilted posture.
次要结局
- Change in Anterior and lateral functional reach test(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Posturography(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Neglect - Mesulam Cancellation Test(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Neglect - Line Bisection(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Lateropulsion Scale(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Postural Assessment Scale for Stroke Patients(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Neglect - Behavioral Inattention Test(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Neglect - Test Dynamic Starry Night(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Subjective Straight Ahead(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
- Change in Sensory evaluation(Before the intervention, after the first day of intervention, after 2 weeks (end of intervention), and one month after the end of the intervention (follow up))
研究者
Nachum Soroker, MD
head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel
Loewenstein Hospital