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Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03271775
Acronym
VOR
Enrollment
100
Registered
2017-09-05
Start date
2017-10-01
Completion date
2019-12-31
Last updated
2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibulopathy, Acute Peripheral

Keywords

Dizziness, Instability

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.

Interventions

OTHERphysical therapy program (group)

Exercises group transmitted by physical therapist (Up to four participant in each group).

OTHERphysical therapy program (computerized exercises)

Remote exercises program accompanied by a physical therapist guidance

Sponsors

University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

After the initial test, subjects will randomly distribute into three different research groups. Each subgroup will include 30 patients.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathyThe 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

MeasureTime frameDescription
Change from baseline velocity sway at 3 and 6 months measured by force platformup to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathyThe 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 questionnireup to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathyThe ABC is one of a several tools designed to measure an individual's confidence in her/his ability to perform daily activities without falling.

Countries

Israel

Contacts

Primary ContactLiraz Tencer-Lagziel, MA
liraztencer@gmail.com+972-9-7440429
Backup ContactOz Zur, PHD
zurbalance@gmail.com+972-9-7440429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026