Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
Primary Purpose
Stroke
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vibration stimuli to neck muscles
Vibration stimuli to hand
conventional physiotherapy
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Vibration Stimuli, Contraversive Pusher Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vibration stimuli to neck
Vibration stimuli to hand
Arm Description
Vibration stimuli to contralesional neck muscles, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes.
Vibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Lateropulsion Scale
Score range: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking.
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.
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.
Change in Posturography
Force Platform that calculates the amount of weight bearing on right and left side during sitting.
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).
Change in Neglect - Mesulam Cancellation Test
Cancellation of forms. Assesses the amount of attention to the left side.
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.
Change in Neglect - Test Dynamic Starry Night
Computerized task. Measures the reaction time and the number of neglected goals.
Change in Subjective Straight Ahead
Assesses the subjective alignment of the body.
Change in Sensory evaluation
Assesses superficial sensation in foot and proprioception in toes.
Full Information
NCT ID
NCT02824900
First Posted
June 29, 2016
Last Updated
October 15, 2017
Sponsor
Nachum Soroker, MD
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT02824900
Brief Title
Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
Official Title
Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nachum Soroker, MD
Collaborators
Tel Aviv University
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Vibration Stimuli, Contraversive Pusher Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibration stimuli to neck
Arm Type
Experimental
Arm Description
Vibration stimuli to contralesional neck muscles, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes.
Arm Title
Vibration stimuli to hand
Arm Type
Active Comparator
Arm Description
Vibration stimuli to contralesional hand, 5 days per week, for 2 weeks, 20 minutes per day + structured (conventional exercises) daily physiotherapy ~ 45 minutes.
Intervention Type
Device
Intervention Name(s)
Vibration stimuli to neck muscles
Intervention Type
Device
Intervention Name(s)
Vibration stimuli to hand
Intervention Type
Behavioral
Intervention Name(s)
conventional physiotherapy
Primary Outcome Measure Information:
Title
Change in Clinical Scale for Contraversive Pushing
Description
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.
Time Frame
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 Measure Information:
Title
Change in Lateropulsion Scale
Description
Score range: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking.
Time Frame
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)
Title
Change in Postural Assessment Scale for Stroke Patients
Description
Score range: 0-36. Score of 36 indicates performance without help. Assesses maintenance and change of posture.
Time Frame
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)
Title
Change in Anterior and lateral functional reach test
Description
Assesses equilibrium during sitting by measuring the distance of the anterior and lateral reaching with the upper limb.
Time Frame
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)
Title
Change in Posturography
Description
Force Platform that calculates the amount of weight bearing on right and left side during sitting.
Time Frame
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)
Title
Change in Neglect - Behavioral Inattention Test
Description
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).
Time Frame
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)
Title
Change in Neglect - Mesulam Cancellation Test
Description
Cancellation of forms. Assesses the amount of attention to the left side.
Time Frame
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)
Title
Change in Neglect - Line Bisection
Description
Assesses the amount of deviation from the center of different lines decided by the subject. Assesses the amount of attention to the left side.
Time Frame
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)
Title
Change in Neglect - Test Dynamic Starry Night
Description
Computerized task. Measures the reaction time and the number of neglected goals.
Time Frame
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)
Title
Change in Subjective Straight Ahead
Description
Assesses the subjective alignment of the body.
Time Frame
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)
Title
Change in Sensory evaluation
Description
Assesses superficial sensation in foot and proprioception in toes.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivi Frenkel-Toledo, PhD
Organizational Affiliation
Loewenstein Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
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