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Clinical Trials/NCT03271775
NCT03271775
Unknown
Not Applicable

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

University of Haifa1 site in 1 country100 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vestibulopathy, Acute Peripheral
Sponsor
University of Haifa
Enrollment
100
Locations
1
Primary Endpoint
Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
December 31, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmeli Eli

Prof.

University of Haifa

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Change from baseline velocity sway at 3 and 6 months measured by force platform(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(up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy)

Study Sites (1)

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