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

August 31, 2017 updated by: Carmeli Eli, University of Haifa

Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit - Characteristics of Overt and Covert Saccadic Eye Movements Measured by the Video Head Impulse Test (vHIT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Ra'anana, Israel, 4330010
        • Israeli Center for the Treatment of Dizziness and Imbalance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program.
Experimental: PT treatment group for balance disorder
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.
Other: physical therapy program (group)
Exercises group transmitted by physical therapist (Up to four participant in each group).
Experimental: independant home computerized exercises
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.
Other: physical therapy program (computerized exercises)
Remote exercises program accompanied by a physical therapist guidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)
Time Frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
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).
up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline velocity sway at 3 and 6 months measured by force platform
Time Frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
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.
up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire
Time Frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
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.
up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Haifa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmeli Eli, Prof, Haifa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UHaifa2808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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