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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physiotherapy including Vestibular rehabilitation
conventional Physiotherapy
Sponsored by
Prof. Dan Justo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring balance, gait, post stroke rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention

control

Arm Description

daily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize.

daily physiotherapy session as part of the rehab plan

Outcomes

Primary Outcome Measures

Dynamic Gait Index
scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.
10 Meters Walking Test
timing walking 10 meters walking
Timed Up and Go test
getting up from a chair, walk for 3 meters and back to the chair.
Activities-specific Balance Confidence Scale
questionnaire for balance confidence in deferent daily tasks
Dynamic visual acuity test
assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement

Secondary Outcome Measures

Full Information

First Posted
November 5, 2019
Last Updated
September 1, 2021
Sponsor
Prof. Dan Justo
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1. Study Identification

Unique Protocol Identification Number
NCT04154969
Brief Title
The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
Official Title
The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dan Justo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
balance, gait, post stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
daily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize.
Arm Title
control
Arm Type
Active Comparator
Arm Description
daily physiotherapy session as part of the rehab plan
Intervention Type
Other
Intervention Name(s)
Physiotherapy including Vestibular rehabilitation
Intervention Description
vestibular exercise (VOR TX1)
Intervention Type
Other
Intervention Name(s)
conventional Physiotherapy
Intervention Description
conventional Physiotherapy
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Description
scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.
Time Frame
10 minute
Title
10 Meters Walking Test
Description
timing walking 10 meters walking
Time Frame
1 minute
Title
Timed Up and Go test
Description
getting up from a chair, walk for 3 meters and back to the chair.
Time Frame
1 minute
Title
Activities-specific Balance Confidence Scale
Description
questionnaire for balance confidence in deferent daily tasks
Time Frame
5 minute
Title
Dynamic visual acuity test
Description
assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement
Time Frame
5 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yochay Noach, B.PT
Phone
+972-50-6798701
Email
ynoach@gmail.com
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yochay noach, B.PT
Phone
03-5303396
Email
yochay.noach@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No
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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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