Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

Conditions
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Stroke

Intervention / Treatment
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* Device: Vibration stimuli to neck muscles
* Device: Vibration stimuli to hand
* Behavioral: conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Having previous neurological and orthopedic disability. Having pacemakers.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration stimuli to neck<br>Vibration stimuli to contralesional neck muscles, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy   45 minutes. | Device: Vibration stimuli to neck muscles<br> <br> Behavioral: conventional physiotherapy<br> <br> |
| Active Comparator: Vibration stimuli to hand<br>Vibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy   45 minutes. | Device: Vibration stimuli to hand<br> <br> Behavioral: conventional physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Scale for Contraversive Pushing | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lateropulsion Scale | Score range: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking. | 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 | Score range: 0-36. Score of 36 indicates performance without help. Assesses maintenance and change of posture. | 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 Anterior and lateral functional reach test | Assesses equilibrium during sitting by measuring the distance of the anterior and lateral reaching with the upper limb. | 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 | Force Platform that calculates the amount of weight bearing on right and left side during sitting. | 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 | Score range: 0-146. Cutoff score: 129. Assesses the amount of attention to the left side during different task (such as: star and lines cancellation). | 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 | Cancellation of forms. Assesses the amount of attention to the left side. | 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 | Assesses the amount of deviation from the center of different lines decided by the subject. Assesses the amount of attention to the left side. | 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 | Computerized task. Measures the reaction time and the number of neglected goals. | 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 | Assesses the subjective alignment of the body. | 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 | Assesses superficial sensation in foot and proprioception in toes. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibration Stimuli, Contraversive Pusher Syndrome