Clinical trial NCT03271775: Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit
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
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibulopathy, Acute Peripheral
Keywords: Dizziness
Instability
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the initial test, subjects will randomly distribute into three different research groups.

Each subgroup will include 30 patients.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)
timeFrame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Secondary outcomes:
measure: Change from baseline velocity sway at 3 and 6 months measured by force platform
timeFrame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
measure: Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire
timeFrame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Other outcomes:
Locations:
city: Ra'anana
country: Israel
facility: Israeli Center for the Treatment of Dizziness and Imbalance
Study officials:
affiliation: Haifa University
name: Carmeli Eli, Prof
role: PRINCIPAL_INVESTIGATOR
References: