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Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome

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ClinicalTrials.gov Identifier: NCT02824900
Recruitment Status : Withdrawn
First Posted : July 7, 2016
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Nachum Soroker, MD, Loewenstein Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Vibration stimuli to neck muscles Device: Vibration stimuli to hand Behavioral: conventional physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vibration Stimuli in Stroke Patients With Contraversive Pusher Syndrome
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Vibration stimuli to neck
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
Behavioral: conventional physiotherapy
Active Comparator: Vibration stimuli to hand
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
Behavioral: conventional physiotherapy



Primary Outcome Measures :
  1. Change in Clinical Scale for Contraversive Pushing [ 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) ]
    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 :
  1. Change in Lateropulsion Scale [ 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) ]
    Score range: 0-17. Score of zero indicated no pushing. Assesses pushing during supine, sitting, standing, transfers and walking.

  2. Change in Postural Assessment Scale for Stroke Patients [ 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) ]
    Score range: 0-36. Score of 36 indicates performance without help. Assesses maintenance and change of posture.

  3. Change in Anterior and lateral functional reach test [ 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) ]
    Assesses equilibrium during sitting by measuring the distance of the anterior and lateral reaching with the upper limb.

  4. Change in Posturography [ 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) ]
    Force Platform that calculates the amount of weight bearing on right and left side during sitting.

  5. Change in Neglect - Behavioral Inattention Test [ 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) ]
    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).

  6. Change in Neglect - Mesulam Cancellation Test [ 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) ]
    Cancellation of forms. Assesses the amount of attention to the left side.

  7. Change in Neglect - Line Bisection [ 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) ]
    Assesses the amount of deviation from the center of different lines decided by the subject. Assesses the amount of attention to the left side.

  8. Change in Neglect - Test Dynamic Starry Night [ 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) ]
    Computerized task. Measures the reaction time and the number of neglected goals.

  9. Change in Subjective Straight Ahead [ 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) ]
    Assesses the subjective alignment of the body.

  10. Change in Sensory evaluation [ 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) ]
    Assesses superficial sensation in foot and proprioception in toes.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824900


Sponsors and Collaborators
Nachum Soroker, MD
Tel Aviv University
Investigators
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Study Director: Sivi Frenkel-Toledo, PhD Loewenstein Hospital
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Responsible Party: Nachum Soroker, MD, head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT02824900    
Other Study ID Numbers: loe162315CTIL
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Keywords provided by Nachum Soroker, MD, Loewenstein Hospital:
Vibration Stimuli
Contraversive Pusher Syndrome
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases