Vestibular RehabilitationNCT04133025
Investigation of The Effect of Web-Based System With Oculomotor and Optokinetic Stimulation on Rehabilitation in Vestibular Hypofunction
A study testing Vestibular Rehabilitation in people with Vestibular Rehabilitation and Vestibular Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate of the effect of web-based System with oculomotor and optokinetic stimulation on rehabilitation in vestibular hypofunction. In the literature, studies on vestibular rehabilitation in unilateral hypofunction are very limited and there is no study about it. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Rehabilitation, Vestibular Disease
- What is being tested?
- Vestibular Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2019to 10 Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral vestibulopathy between the ages of 18-75,
- No visual disability
Who cannot join
- Mental retardation,
- Inadequate communication in Turkish;
- Having neurological problems,
- Bilateral vestibular hypofunction
- There is a serious orthopedic problem that will prevent standing and walking.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Physiotherapy and Rehabilitation Doctoral Programme
Istanbul
About this study
The aim of this study was to investigate of the effect of web-based System with oculomotor and optokinetic stimulation on rehabilitation in vestibular hypofunction. In the literature, studies on vestibular rehabilitation in unilateral hypofunction are very limited and there is no study about it.
Read the detailed description
Vestibular system is one of the sensory systems used for postural control. The function of this system is to maintain balance during head movements and to sense the sense of position in the space.Information from the vestibular system goes to the neural processing center. To achieve or maintain postural control as a result of neural reorganization, balance is achieved by controlling eye movements and muscles.
Basic symptoms in vestibular pathologies are; vertigo and dizziness. Besides these; vestibulo-visual symptoms (oscillopsia, decreased visual acuity, visual tilt, etc.), postural symptoms (feeling of falling, swaying, etc.), and symptoms of motion sickness are. The occurrence of these symptoms varies according to diseases and individual characteristics.
In the treatment of vestibular diseases; there are medical treatment, vestibular rehabilitation, surgical interventions and psychosocial education.Medical treatments; it is often used to suppress or control vestibular symptoms (nausea, etc.). Surgical interventions are the last choice of treatment in patients with severe attacks such as disabling function such as labyrinthectomy or signaling the vestibular nerve. Vestibular Rehabilitation is an exercise based approach to maximize central nervous system compensation for vestibular pathology.
In recent years, the effectiveness of the technologies that have been used in different areas of rehabilitation in vestibular rehabilitation has started to be investigated. In the researches, it is seen that virtual reality is one of the most used technologies. In terms of virtual reality usage, it has cost, size and portability advantages (3). However, in other studies, different systems apart from virtual reality are almost not found among the assistive technologies in vestibular rehabilitation.
In recent years, vestibular rehabilitation methods, adaptation to changing sensory conditions and sensory repetition methods in compensation process have been emphasized to increase adaptation to vestibular losses. However, individual therapeutic programs need to be planned in accordance with clinical symptoms. To this end, there is a need to develop reliable objective and technological feedback techniques to measure the interaction of peripheral senses and central adjustment mechanisms.
- Conditions
- Vestibular Rehabilitation, Vestibular Disease
- Being tested
- Vestibular Rehabilitation
- Keywords
- Vestibular Rehabilitation, Unilateral vestibular hypofunction
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationOther
Vestibular Exercises and Software in vestibular rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Conventional vestibular rehabilitation | Active comparator | Conventional vestibular rehabilitation Receives: Other: Vestibular Rehabilitation |
| Vestibular rehabilitation with software | Active comparator | Not described Receives: Other: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Results of Head Thrust Test
It tests the vestibulo-ocular reflex (VOR).The examiner holds the patient's head steady in the midline. The patient is instructed to maintain gaze on the nose of the examiner. The examiner then quickly turns the patient's head about 10-15 degrees to one side and observes the ability of the patient to keep the eyes locked on the examiner's nose. the test can also be performed by starting with the head turned to the side, and then making the quick movement back to the midline. If the patient's eyes stay locked on the examiner's nose (i.e., no corrective saccade) , then the peripheral vestibular system is assumed to be intact. Thus in a patient with acute dizziness, the absence of a corrective saccade suggests a Central Neural System(CNS) localization. If, however, the patient's eyes move with the head and then the patient makes a voluntary eye movement back to the examiner's nose (i.e., corrective saccade), then this suggests a lesion of the peripheral vestibular system and not the CNS
Measured: Eight weeks.
Change In Results of Balance Tests At 8 Weeks.
Periodic balance tests are standing on romberg, semi-tandem, tandem, one-leg positions with eyes open and closed in seconds and are recorded by timekeeper.
Measured: Eight weeks.
Change In Levels of Oculomotor Functions
Oculomotor functions are Saccade and Pursuit. They are assessed by software with normal oculomotor frequencies in Hertz.
Measured: Eight weeks.
Change In Results of Head Shake Test at 8 weeks.
The head-shaking test allows determination of an asymmetry between the two horizontal canals [1]. The head of the patient is shaken in the horizontal plane for 20 s and at the end of the stimulation the induced eye movements are observed. If the post head shaking nystagmus is shown, test is positive.
Measured: Eight weeks.
Change In Results of Unterberger Test at 8 weeks
The Unterberger stepping test is a simple means of identifying which labyrinth may be dysfunctional in a peripheral vertigo. The purpose of the Unterberger Test (UT) is to measure asymmetrical vestibulospinal reflex tone resulting from labyrinthine dysfunction. The UT is a low cost evaluation for dizzy patients; however, when compared with gold standard caloric irrigation unilateral weakness (UW) value ≥25%, the UT has not been shown to be a sensitive tool for identifying unilateral vestibular hypofunction
Measured: Eight weeks.
Secondary outcomes (2)
Kinesiophobia Assessment
Tampa Kinesiophobia Scale (TKS) is used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
Measured: Before and after eight weeks treatment programmes
Quality of Life Assessment: Dizziness Handicap Inventory
Dizziness Handicap Inventory is used. The purpose of this scale is to identify difficulties that you may be experiencing because of your dizziness.Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0.
Measured: Before and after eight weeks treatment programmes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start17 Jan 2019
- Primary completion1 Aug 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular RehabilitationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gonulertunc, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133025
- Sponsor's protocol ID
- 3120598858
- Status last verified
- Mar 2020
- First submitted
- 22 Jul 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ertunc Gulcelik G, Tarakci D, Gedik Soyuyuce O, Gence Gumus Z, Korkut N, Algun ZC. Research on the Effects of a Web-Based System With Oculomotor and Optokinetic Stimuli on Vestibular Rehabilitation. Am J Phys Med Rehabil. 2021 Jun 1;100(6):555-562. doi: 10.1097/PHM.0000000000001584.
PubMed 32889859
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effect of Web-Based System With Oculomotor and Optokinetic Stimulation on Rehabilitation in Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT04133025
- Acronym / sponsor ID
- 3120598858
- Conditions
- Vestibular Rehabilitation, Vestibular Disease
- Keywords
- Vestibular Rehabilitation, Unilateral vestibular hypofunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 21 Oct 2019 (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 aim of this study was to investigate of the effect of web-based System with oculomotor and optokinetic stimulation on rehabilitation in vestibular hypofunction. In the literature, studies on vestibular rehabilitation in unilateral hypofunction are very limited and there is no study about it.
Detailed description
Vestibular system is one of the sensory systems used for postural control. The function of this system is to maintain balance during head movements and to sense the sense of position in the space.Information from the vestibular system goes to the neural processing center. To achieve or maintain postural control as a result of neural reorganization, balance is achieved by controlling eye movements and muscles.
Basic symptoms in vestibular pathologies are; vertigo and dizziness. Besides these; vestibulo-visual symptoms (oscillopsia, decreased visual acuity, visual tilt, etc.), postural symptoms (feeling of falling, swaying, etc.), and symptoms of motion sickness are. The occurrence of these symptoms varies according to diseases and individual characteristics.
In the treatment of vestibular diseases; there are medical treatment, vestibular rehabilitation, surgical interventions and psychosocial education.Medical treatments; it is often used to suppress or control vestibular symptoms (nausea, etc.). Surgical interventions are the last choice of treatment in patients with severe attacks such as disabling function such as labyrinthectomy or signaling the vestibular nerve. Vestibular Rehabilitation is an exercise based approach to maximize central nervous system compensation for vestibular pathology.
In recent years, the effectiveness of the technologies that have been used in different areas of rehabilitation in vestibular rehabilitation has started to be investigated. In the researches, it is seen that virtual reality is one of the most used technologies. In terms of virtual reality usage, it has cost, size and portability advantages (3). However, in other studies, different systems apart from virtual reality are almost not found among the assistive technologies in vestibular rehabilitation.
In recent years, vestibular rehabilitation methods, adaptation to changing sensory conditions and sensory repetition methods in compensation process have been emphasized to increase adaptation to vestibular losses. However, individual therapeutic programs need to be planned in accordance with clinical symptoms. To this end, there is a need to develop reliable objective and technological feedback techniques to measure the interaction of peripheral senses and central adjustment mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional vestibular rehabilitation | Active comparator | Other: Vestibular RehabilitationConventional vestibular rehabilitation |
| Vestibular rehabilitation with software | Active comparator | Other: Vestibular Rehabilitation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral vestibulopathy between the ages of 18-75,
- No visual disability
Key exclusion criteria (5 listed)
- Mental retardation,
- Inadequate communication in Turkish;
- Having neurological problems,
- Bilateral vestibular hypofunction
- There is a serious orthopedic problem that will prevent standing and walking.
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 |
|---|---|---|
| Vestibular RehabilitationVestibular Exercises and Software in vestibular rehabilitation | Other | Conventional vestibular rehabilitation, Vestibular rehabilitation with software |
Primary outcome
Change In Results of Head Thrust Test
Time frame: Eight weeks.
It tests the vestibulo-ocular reflex (VOR).The examiner holds the patient's head steady in the midline. The patient is instructed to maintain gaze on the nose of the examiner. The examiner then quickly turns the patient's head about 10-15 degrees to one side and observes the ability of the patient to keep the eyes locked on the examiner's nose. the test can also be performed by starting with the head turned to the side, and then making the quick movement back to the midline. If the patient's eyes stay locked on the examiner's nose (i.e., no corrective saccade) , then the peripheral vestibular system is assumed to be intact. Thus in a patient with acute dizziness, the absence of a corrective saccade suggests a Central Neural System(CNS) localization. If, however, the patient's eyes move with the head and then the patient makes a voluntary eye movement back to the examiner's nose (i.e., corrective saccade), then this suggests a lesion of the peripheral vestibular system and not the CNS
Change In Results of Balance Tests At 8 Weeks.
Time frame: Eight weeks.
Periodic balance tests are standing on romberg, semi-tandem, tandem, one-leg positions with eyes open and closed in seconds and are recorded by timekeeper.
Change In Levels of Oculomotor Functions
Time frame: Eight weeks.
Oculomotor functions are Saccade and Pursuit. They are assessed by software with normal oculomotor frequencies in Hertz.
Change In Results of Head Shake Test at 8 weeks.
Time frame: Eight weeks.
The head-shaking test allows determination of an asymmetry between the two horizontal canals [1]. The head of the patient is shaken in the horizontal plane for 20 s and at the end of the stimulation the induced eye movements are observed. If the post head shaking nystagmus is shown, test is positive.
Change In Results of Unterberger Test at 8 weeks
Time frame: Eight weeks.
The Unterberger stepping test is a simple means of identifying which labyrinth may be dysfunctional in a peripheral vertigo. The purpose of the Unterberger Test (UT) is to measure asymmetrical vestibulospinal reflex tone resulting from labyrinthine dysfunction. The UT is a low cost evaluation for dizzy patients; however, when compared with gold standard caloric irrigation unilateral weakness (UW) value ≥25%, the UT has not been shown to be a sensitive tool for identifying unilateral vestibular hypofunction
2 secondary outcomes
Kinesiophobia Assessment
Time frame: Before and after eight weeks treatment programmes
Quality of Life Assessment: Dizziness Handicap Inventory
Time frame: Before and after eight weeks treatment programmes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 32889859Ertunc Gulcelik G, Tarakci D, Gedik Soyuyuce O, Gence Gumus Z, Korkut N, Algun ZC. Research on the Effects of a Web-Based System With Oculomotor and Optokinetic Stimuli on Vestibular Rehabilitation. Am J Phys Med Rehabil. 2021 Jun 1;100(6):555-562. doi: 10.1097/PHM.0000000000001584.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation in people with Vestibular Rehabilitation and Vestibular Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 Mar 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In Results of Head Thrust Test (time frame: Eight weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133025, which also lists 1 linked publication.
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 18 Mar 2020.