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The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients

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ClinicalTrials.gov Identifier: NCT04154969
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dan Justo, Sheba Medical Center

Study Description
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Brief Summary:
This study evaluate the effect of Vestibular rehabilitation program as part of physical therapy during rehabilitation post stroke. half of participants will receive vestibular exercise as part of the physiotherpy session, while the other half will receive a conservative physiotherapy session.

Condition or disease Intervention/treatment Phase
Stroke Other: Physiotherapy including Vestibular rehabilitation Other: conventional Physiotherapy Not Applicable

Detailed Description:

Background Stroke global incidence is rising, in Israel 40% of the stroke patients are in need for hospitalized rehabilitation. Improving mobility, and in particular walking after stroke, is utterly important to reduce the risk of falling and is strongly correlated to higher patient autonomy and improved quality of life. During walking balance maintenance, is a complex function relying upon three modalities of sensory information. The sensory weighting process is compromised in stroke patients, so they are excessively reliant on visual information to control their posture. applying vestibular inputs, such as vestibulo-ocular reflex (VOR) habituation exercise, as part of vestibular focused rehabilitation (VR) is one of the methods to trigger sensory reweighting processes in post stroke patients. The VOR role in balance is to assist stabilizing images on the retina during head movement. It may be possible to explain the phenomena of head stabilization during gait in post stroke patients, as an attempt to maintain gaze stability due to reduced dynamic visual acuity (DVA) arising from decreased VOR function.

Aims The aims of this study are firstly to investigate the effectiveness of VOR exercise on gait speed and balance in post stroke patients with no dizziness, and secondly, to test the correlation between the efficiency of the VOR, as reflected by DVA and gait velocity.

Methods A prospective experimental study, randomized controlled, double blinded (assessor and statistician). Sixty adults, 65 years and older, hospitalized in the geriatric rehabilitation departments at the Sheba Medical Center, Israel will be divided to control and intervention groups. The intervention will include physiotherapy sessions including 10 minutes dedicated to VOR habituation exercise, comparing to physiotherapy sessions with no VOR exercise.

Prior to the baseline testing (T1), the participants will perform the outcome measures tests twice (two consecutive days) to determine the smallest real difference. Following this, the outcome measures will be tested at three time-points: before the beginning of the vestibular training (T1); three weeks later, at the termination of the vestibular training (T2) and three weeks after the termination of the training period (T3), to measure retention. For assessing gait and balance, the Dynamic Gait Index (appendix 1), the 10 Meters Walking Test (appendix 2) and the Timed Up and Go test (appendix 3) will be utilized. For assessing balance confidence the Activities-specific Balance Confidence Scale (ABC) questionnaire will be applied. For assessing the DVA, the Dynamic visual acuity test will be applied.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
Estimated Study Start Date : November 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention
daily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize.
 Other: Physiotherapy including Vestibular rehabilitation
vestibular exercise (VOR TX1)
Active Comparator: control
daily physiotherapy session as part of the rehab plan
 Other: conventional Physiotherapy
conventional Physiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Dynamic Gait Index [ Time Frame: 10 minute ]
    scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.

  2. 10 Meters Walking Test [ Time Frame: 1 minute ]
    timing walking 10 meters walking

  3. Timed Up and Go test [ Time Frame: 1 minute ]
    getting up from a chair, walk for 3 meters and back to the chair.

  4. Activities-specific Balance Confidence Scale [ Time Frame: 5 minute ]
    questionnaire for balance confidence in deferent daily tasks

  5. Dynamic visual acuity test [ Time Frame: 5 minute ]
    assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

within 0-3 months of a stroke (ischemic or hemorrhagic; anterior or posterior circulation; not vertebro-basilar stroke).

Exclusion Criteria:

any significant medical illness or blood pressure at rest>110/200 mmHg; a Mini-Mental State Exam score <24, global; a receptive aphasia or an inability to follow 2-point commands; unable to walk 16 meters with no physical assistance.

Contacts and Locations
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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): NCT04154969


Contacts
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Contact: Yochay Noach, B.PT +972-50-6798701 ynoach@gmail.com

Sponsors and Collaborators
Prof. Dan Justo
More Information
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Publications:
ICDC. Stroke Registry Report for 2015-2016.; 2016. https://www.health.gov.il/publicationsfiles/stroke_registry_report_2014-2015.pdf.
Ifrah A, Arditi T, Sever L, Tanne D, Koton S. National acute stroke israeli survey (NASIS) 2010. Natl Acute Stroke Isr Surv 2010. 2010;(ICDC):1-43.
Yeole UL, Raut RV. Effect of proprioceptive exercise program versus vestibular rehabilitation therapy on risk of fall in elderly. 2018;3(December):117-122.

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Responsible Party: Prof. Dan Justo, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04154969    
Other Study ID Numbers: SHEBA-19-6371-DJ-CTIL
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dan Justo, Sheba Medical Center:
balance
gait
post stroke rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases