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Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit (VOR)

Primary Purpose

Vestibulopathy, Acute Peripheral

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
physical therapy program (group)
physical therapy program (computerized exercises)
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibulopathy, Acute Peripheral focused on measuring Dizziness, Instability

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with unilateral or bilateral vestibulopathy living independently in the community

Exclusion Criteria:

  • cognitive state decline neurological disorder disease or disorders that can affect balance

Sites / Locations

  • Israeli Center for the Treatment of Dizziness and Imbalance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

PT treatment group for balance disorder

independant home computerized exercises

Arm Description

Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program.

Patients in this research group will join to a 3 months' physical therapy treatment group designed to improve balance. The service for the group is provided by laboratory.

Patients in this group will be treated by 3 months' independent home computerized exercise program. Each patient will receive a personal access code for the exercise program. The duration of each practice is 5-10 minutes per day.

Outcomes

Primary Outcome Measures

Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)
The Vhit incorporates a new technology that uses a high speed light weight video goggle to measure high velocity and record "catch up" saccades in patients with impaired VOR function. we will examine the changes from baseline in the latency, frequency and duration of the overt and covert saccadic eye movements. In addition, we would like to examine changes over time in the ratio between the head and the eye movement (Gain).

Secondary Outcome Measures

Change from baseline velocity sway at 3 and 6 months measured by force platform
The force plate is designed to measure the forces and moments applied to its top surface as a subjects stands, steps, or jumps on it. Force plates are regularly used in research and clinical studies looking at balance, gait, and sports performance (www.amti.biz). Center of pressure (COP) data during the stability tests will be sampled at a frequency of 100 Hz. We will perform the zur balance scale (ZBS) on the plate at each time and evaluate the changes from baseline.
Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire
The ABC is one of a several tools designed to measure an individual's confidence in her/his ability to perform daily activities without falling.

Full Information

First Posted
August 2, 2017
Last Updated
August 31, 2017
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT03271775
Brief Title
Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit
Acronym
VOR
Official Title
Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit - Characteristics of Overt and Covert Saccadic Eye Movements Measured by the Video Head Impulse Test (vHIT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is examine the eye movements characteristics of patients with VOR gain deficits (overt and covert saccades) before and after physical therapy intervention program and examine the most effective physical therapy treatment program for patients with vestibulopathy.
Detailed Description
The vestibular system receives and conveys information about head motion in space, and is the main human sensory system dedicated to detecting self-motion.The vestibular system plays a crucial role in static and dynamic balance control, stabilizing the head and trunk, especially on unstable surfaces . In terms of postural control and falls, the literature describes a direct association between VOR deficits, gait instability, and falls.The "gain" of the VOR is defined as the change in the eye angle divided by the change in the head angle during the head turn. Under ideal conditions, the gain of the rotational VOR is 1.0, meaning there is a compensatory eye velocity equal to the head velocity and in the opposite direction. In case of a positive vHIT, the VOR gain is decreased and refixating saccades are observed. The video Head Impulse Test measures eye velocity during head rotation. Instant feedback about every single head impulse allows the examiner to apply a set of standardized graded impulses. The system is easy to use in a clinical setting, provides an objective measure of the VOR, and detects both overt and covert catch-up saccades in patients with vestibular loss. Measurements are quick and noninvasive, and the automated analysis software provides instant results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibulopathy, Acute Peripheral
Keywords
Dizziness, Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After the initial test, subjects will randomly distribute into three different research groups. Each subgroup will include 30 patients.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program.
Arm Title
PT treatment group for balance disorder
Arm Type
Experimental
Arm Description
Patients in this research group will join to a 3 months' physical therapy treatment group designed to improve balance. The service for the group is provided by laboratory.
Arm Title
independant home computerized exercises
Arm Type
Experimental
Arm Description
Patients in this group will be treated by 3 months' independent home computerized exercise program. Each patient will receive a personal access code for the exercise program. The duration of each practice is 5-10 minutes per day.
Intervention Type
Other
Intervention Name(s)
physical therapy program (group)
Intervention Description
Exercises group transmitted by physical therapist (Up to four participant in each group).
Intervention Type
Other
Intervention Name(s)
physical therapy program (computerized exercises)
Intervention Description
Remote exercises program accompanied by a physical therapist guidance
Primary Outcome Measure Information:
Title
Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)
Description
The Vhit incorporates a new technology that uses a high speed light weight video goggle to measure high velocity and record "catch up" saccades in patients with impaired VOR function. we will examine the changes from baseline in the latency, frequency and duration of the overt and covert saccadic eye movements. In addition, we would like to examine changes over time in the ratio between the head and the eye movement (Gain).
Time Frame
up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Secondary Outcome Measure Information:
Title
Change from baseline velocity sway at 3 and 6 months measured by force platform
Description
The force plate is designed to measure the forces and moments applied to its top surface as a subjects stands, steps, or jumps on it. Force plates are regularly used in research and clinical studies looking at balance, gait, and sports performance (www.amti.biz). Center of pressure (COP) data during the stability tests will be sampled at a frequency of 100 Hz. We will perform the zur balance scale (ZBS) on the plate at each time and evaluate the changes from baseline.
Time Frame
up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Title
Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire
Description
The ABC is one of a several tools designed to measure an individual's confidence in her/his ability to perform daily activities without falling.
Time Frame
up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with unilateral or bilateral vestibulopathy living independently in the community Exclusion Criteria: cognitive state decline neurological disorder disease or disorders that can affect balance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liraz Tencer-Lagziel, MA
Phone
+972-9-7440429
Email
liraztencer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Oz Zur, PHD
Phone
+972-9-7440429
Email
zurbalance@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmeli Eli, Prof
Organizational Affiliation
Haifa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Israeli Center for the Treatment of Dizziness and Imbalance
City
Ra'anana
ZIP/Postal Code
4330010
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the data for all primary and secondary outcome measure will be available
IPD Sharing Time Frame
data will be available within 6 months of study completion
IPD Sharing Access Criteria
Requestor will be required to sign a data access agreement

Learn more about this trial

Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit

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