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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Withdrawn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
Nachum Soroker, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Vibration Stimuli, Contraversive Pusher Syndrome

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 29, 2016
    Last Updated
    October 15, 2017
    Sponsor
    Nachum Soroker, MD
    Collaborators
    Tel Aviv University
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    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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