Vestibulopathy, Acute PeripheralVORNCT03271775
Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit
A study testing physical therapy program (group) and physical therapy program (computerized exercises) in people with Vestibulopathy, Acute Peripheral, run by University of Haifa at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vestibulopathy, Acute Peripheral
- What is being tested?
- physical therapy program (group) and physical therapy program (computerized exercises)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with unilateral or bilateral vestibulopathy living independently in the community
Who cannot join
- cognitive state decline neurological disorder disease or disorders that can affect balance
Trial locations and contacts
1 site in 1 country.
Israel1 site
Israeli Center for the Treatment of Dizziness and Imbalance
Raanana, 4330010
About this study
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)
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.
- Conditions
- Vestibulopathy, Acute Peripheral
- Being tested
- physical therapy program (group), physical therapy program (computerized exercises)
- Keywords
- Dizziness, Instability
- Medical subject headings
- Vestibular Neuronitis, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy program (group)Other
Exercises group transmitted by physical therapist (Up to four participant in each group).
physical therapy program (computerized exercises)Other
Remote exercises program accompanied by a physical therapist guidance
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program. |
| PT treatment group for balance disorder | Experimental | 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. Receives: Other: physical therapy program (group) |
| independant home computerized exercises | Experimental | 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. Receives: Other: physical therapy program (computerized exercises) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibulopathy, Acute PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the initial test, subjects will randomly distribute into three different research groups. Each subgroup will include 30 patients.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmeli Eli, University of Haifa
- Investigators
- Carmeli Eli, Prof, Principal investigator, Haifa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271775
- Sponsor's protocol ID
- UHaifa2808
- Acronym
- VOR
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data for all primary and secondary outcome measure will be available
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03271775
- Acronym / sponsor ID
- VOR / UHaifa2808
- Conditions
- Vestibulopathy, Acute Peripheral
- Keywords
- Dizziness, Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- After the initial test, subjects will randomly distribute into three different research groups. Each subgroup will include 30 patients.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program. |
| PT treatment group for balance disorder | Experimental | Other: physical therapy program (group)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. |
| independant home computerized exercises | Experimental | Other: physical therapy program (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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with unilateral or bilateral vestibulopathy living independently in the community
Key exclusion criteria (1 listed)
- cognitive state decline neurological disorder disease or disorders that can affect balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapy program (group)Exercises group transmitted by physical therapist (Up to four participant in each group). | Other | PT treatment group for balance disorder |
| physical therapy program (computerized exercises)Remote exercises program accompanied by a physical therapist guidance | Other | independant home computerized exercises |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: Yes. the data for all primary and secondary outcome measure will be available
Related trials for Vestibulopathy, Acute Peripheral
Not yet recruiting
Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Acute Vestibular Syndrome, Vertigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmeli Eli, Prof principal investigator
Haifa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy program (group) and physical therapy program (computerized exercises) in people with Vestibulopathy, Acute Peripheral, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liraz Tencer-Lagziel, MA (+972-9-7440429, liraztencer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.