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Status unknownNCT03271775VORUpdated Sep 5, 2017

Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit

An interventional study of physical therapy program (group) and physical therapy program (computerized exercises) in Vestibulopathy, Acute Peripheral, sponsored by University of Haifa. Status unknown at 1 site in Israel. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by University of Haifa · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vestibulopathy, Acute Peripheral

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Keywords

  • Dizziness
  • Instability
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cognitive state decline neurological disorder disease or disorders that can affect balance
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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)

  • 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)

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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

Secondary outcomes

  1. 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.

    Time frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

  2. 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.

    Time frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

06

Study locations

1 site
  • Israeli Center for the Treatment of Dizziness and Imbalance
    Ra'anana, 4330010, Israel
07

References and documents

Individual participant data

Plan to share: Yes — the data for all primary and secondary outcome measure will be available

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03271775
Lead sponsor
University of Haifa
Responsible party
Carmeli Eli (Prof., University of Haifa) — Principal investigator
First posted
Sep 5, 2017
Start date
Oct 1, 2017 (estimated)
Primary completion
Oct 31, 2018 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Sep 5, 2017

Study contacts

Liraz Tencer-Lagziel, MA
Contact
liraztencer@gmail.com
+972-9-7440429
Oz Zur, PHD
Contact
zurbalance@gmail.com
+972-9-7440429
Carmeli Eli, Prof
principal investigator · Haifa University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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