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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

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date November 13, 2019
Estimated Study Start Date  ICMJE November 10, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • Dynamic Gait Index [ Time Frame: 10 minute ]
    scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.
  • 10 Meters Walking Test [ Time Frame: 1 minute ]
    timing walking 10 meters walking
  • Timed Up and Go test [ Time Frame: 1 minute ]
    getting up from a chair, walk for 3 meters and back to the chair.
  • Activities-specific Balance Confidence Scale [ Time Frame: 5 minute ]
    questionnaire for balance confidence in deferent daily tasks
  • Dynamic visual acuity test [ Time Frame: 5 minute ]
    assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Dynamic Gait Index [ Time Frame: 10 minute ]
    scoring walking while performing deferent tasks, such as walking around obsticle, turn head while walking.
  • 10 Meters Walking Test [ Time Frame: 1 minute ]
    timing walking 10 meters walking
  • Timed Up and Go test [ Time Frame: 1 minute ]
    getting up from a chair, walk for 3 meters and back to the chair.
  • Activities-specific Balance Confidence Scale [ Time Frame: 5 minute ]
    questionnaire for ballamce confidence in deferent daily tasks
  • Dynamic visual acuity test [ Time Frame: 5 minute ]
    assessing the Vestibulo-ocular reflex by quantifing the visual acuity during head movement
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
Official Title  ICMJE The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Other: Physiotherapy including Vestibular rehabilitation
    vestibular exercise (VOR TX1)
  • Other: conventional Physiotherapy
    conventional Physiotherapy
Study Arms  ICMJE
  • Experimental: intervention
    daily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize.
    Intervention: Other: Physiotherapy including Vestibular rehabilitation
  • Active Comparator: control
    daily physiotherapy session as part of the rehab plan
    Intervention: Other: conventional Physiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yochay Noach, B.PT +972-50-6798701 ynoach@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154969
Other Study ID Numbers  ICMJE SHEBA-19-6371-DJ-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dan Justo, Sheba Medical Center
Study Sponsor  ICMJE Prof. Dan Justo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheba Medical Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP