Individuals With Vestibular HypofunctionNCT05231109
Effect of Vestibular Rehabilitation in Patients With Bilateral Vestibular Hypofunction
A study testing vestibular rehabilitation in people with Individuals With Vestibular Hypofunction and Individuals Between the Ages of 18-65, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Bilateral vestibular function is a heterogeneous chronic condition characterized by bilaterally decreased or absent function of vestibular organs, vestibular nerves, or both.1 Patients present with various symptoms such as oscillopsia, imbalance, visual vertigo, cognitive deficits, autonomic symptoms, and impaired… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Individuals With Vestibular Hypofunction, Individuals Between the Ages of 18-65
- 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
- 21 Dec 2018to 24 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
- To be diagnosed with bilateral vestibular hypofunction by Videonystagmography test
- To be between the ages of 18-75
- To have communication and cooperation skills
- To have no problems originating from the central nervous system
- To have previously had ear infections, not having undergone surgery
Who cannot join
- Having cognitive dysfunction
- Presence of temporal bone pathologies detected by magnetic resonance imaging
- Presence of other inner ear disorders that may cause dizziness and imbalance as determined by audiogram, tympanogram, and acoustic reflexes
- Previous lower extremity injuries
- The presence of central findings in Videonystagmography results
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bağcılar Safa Hastanesi
Bağcılar, Yıldıztepe, 34203
About this study
Official title: The Effect of Vestibular Rehabilitation on Balance and Quality of Life in Patients With Bilateral Vestibular Hypofunction
Bilateral vestibular function is a heterogeneous chronic condition characterized by bilaterally decreased or absent function of vestibular organs, vestibular nerves, or both.1 Patients present with various symptoms such as oscillopsia, imbalance, visual vertigo, cognitive deficits, autonomic symptoms, and impaired spatial orientation. The aim of this study is to investigate the effectiveness of vestibular rehabilitation on balance, dynamic visual acuity and quality of life in patients with bilateral vestibular hypofunction. Twenty patients diagnosed with bilateral vestibular hypofunction by videonystagmography were included in the study. Balance Tests, Visual Analogue Scale, Dynamic Visual Acuity, Dizziness Disability Inventory for quality of life, computer modified for Sensory Interaction in Balance Clinical Test (MCTSIB) tests and Limits of Stability test, which provides evaluation of body movements, which are an important part of balance, in all directions. Evaluations were made at 3 and 6 months before treatment. Physiotherapy sessions were given at two-week intervals. According to the development of the patients, they were asked to perform a home exercise program with 10 repetitions 3 times a day.
Read the detailed description
After the initial evaluations, the patients included in the study were included in the rehabilitation program. The rehabilitation program consisted of two phases. The first phase included patient education. All patients were planned to receive a verbal training for 30 minutes by the physiotherapist, including the definition of unilateral vestibular hypofunction, its importance, risk factors, ways of prevention, and recommendations for preventing falls. The second phase consisted of the vestibular exercise program. In this phase, vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The exercise program was arranged 3 times a day for 6 months, and each exercise was 10 repetitions. The patients were called for physiotherapist control once every 2 weeks. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month.
- Being tested
- vestibular rehabilitation
- Keywords
- Bilateral vestibular hypofunction, Quality of life, Balance, Vestibular rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular rehabilitationOther
Vestibular rehabilitation consisted of a total of 12 sessions, rearranged every 15 days. These exercises were prepared gradually to increase the vestibulo-ocular reflex and vestibulospinal reflex. The following exercises were done with the patients: vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The therapist gave the patients a home exercise program. It was emphasized that the exercises should be applied as 10 repetitions. After the session, the exercises shown to the patients were explained in written form and given as home exercises. They were also asked to do home exercises 3 times a day, 10 repetitions, for 15 days. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month.
| Study group | Role | What they receive |
|---|---|---|
| vestibular rehabilitation group | Other | Vestibular rehabilitation was performed. The following exercises were done with the patients: vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The exercise program was arranged 3 times a day for 6 months, and each exercise was 10 repetitions. The patients were called for physiotherapist control once every 2 weeks. Receives: Other: vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Static Posture Evaluation at 6 Months (Limits of Stability and modified for Sensory Interaction in Balance Clinical Test )
With the limits of stability program on the balance device called Otometrics ICS Balance Platform, the body's final reaching points, the speed of movement, and direct control were evaluated, in 8 directions. Within this device, the modified for Sensory Interaction in Balance Clinical Test test was evaluated by showing areas of oscillation. Modified-CTSIB is a clinical test that is generally used as a semi-quantitative test measurement, and is scored according to the person's ability to perform various standing static positions.Before removing the patient on the device, the center of gravity is determined by entering the height and weight, and the patient visually sees the center of gravity when he/she gets on the balance platform. Then all tests are done according to this center of gravity.
Measured: 6 months
Change from Baseline Dizziness Handicap Inventory at 6 Months
Dizziness Handicap Inventory was used to evaluate the quality of life of patients. This scale consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases.
Measured: 6 months
Secondary outcomes (3)
Results of Dynamic Visual Acuity, Subjective Visual
The test was performed using the Snellen visual acuity chart. During the test, the patient was first asked where he read on the eye board on the wall while the head was fixed, and it was recorded. Then, while the patient's head was turned to the right and left rapidly 2 times per second, the patient was asked to continue reading on the eye board, and the answers were recorded.
Measured: 6 months
Results of Dizziness Severity Scale, Subjective Visual
A 10-cm visual analog scale was used for evaluation. Patients were asked to rate the severity of dizziness on a scale of 0-10. It was explained that a score of "0" meant no dizziness at all, while a score of "10" indicated the presence of unbearable dizziness, and the patient was asked to mark the appropriate part.
Measured: 6 month
Results of Tandem, Semi-tandem, Romberg and One-Leg Stance Test, Subjective Visual
For balance tests, tandem, semitandem, romberg, standing on one leg on hard ground, and standing on one leg on soft ground were evaluated with eyes open and eyes closed, and the second was recorded as seconds with a stopwatch. The test was considered completed in patients who could stand for 30 seconds.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start21 Dec 2018
- Primary completion3 Jan 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals With Vestibular HypofunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gamze Kılıç, master, Principal investigator, PhD studentZ. Candan Algun, professor, Study director, head of physical medicine and rehabilitaton department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231109
- Sponsor's protocol ID
- 10840098-604.01.01-E.53654
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Rehabilitation on Balance and Quality of Life in Patients With Bilateral Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT05231109
- Acronym / sponsor ID
- 10840098-604.01.01-E.53654
- Keywords
- Bilateral vestibular hypofunction, Quality of life, Balance, Vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 9 Feb 2022 (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.
Bilateral vestibular function is a heterogeneous chronic condition characterized by bilaterally decreased or absent function of vestibular organs, vestibular nerves, or both.1 Patients present with various symptoms such as oscillopsia, imbalance, visual vertigo, cognitive deficits, autonomic symptoms, and impaired spatial orientation. The aim of this study is to investigate the effectiveness of vestibular rehabilitation on balance, dynamic visual acuity and quality of life in patients with bilateral vestibular hypofunction. Twenty patients diagnosed with bilateral vestibular hypofunction by videonystagmography were included in the study. Balance Tests, Visual Analogue Scale, Dynamic Visual Acuity, Dizziness Disability Inventory for quality of life, computer modified for Sensory Interaction in Balance Clinical Test (MCTSIB) tests and Limits of Stability test, which provides evaluation of body movements, which are an important part of balance, in all directions. Evaluations were made at 3 and 6 months before treatment. Physiotherapy sessions were given at two-week intervals. According to the development of the patients, they were asked to perform a home exercise program with 10 repetitions 3 times a day.
Detailed description
After the initial evaluations, the patients included in the study were included in the rehabilitation program. The rehabilitation program consisted of two phases. The first phase included patient education. All patients were planned to receive a verbal training for 30 minutes by the physiotherapist, including the definition of unilateral vestibular hypofunction, its importance, risk factors, ways of prevention, and recommendations for preventing falls. The second phase consisted of the vestibular exercise program. In this phase, vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The exercise program was arranged 3 times a day for 6 months, and each exercise was 10 repetitions. The patients were called for physiotherapist control once every 2 weeks. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vestibular rehabilitation group | Other | Other: vestibular rehabilitationVestibular rehabilitation was performed. The following exercises were done with the patients: vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The exercise program was arranged 3 times a day for 6 months, and each exercise was 10 repetitions. The patients were called for physiotherapist control once every 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be diagnosed with bilateral vestibular hypofunction by Videonystagmography test
- To be between the ages of 18-75
- To have communication and cooperation skills
- To have no problems originating from the central nervous system
- To have previously had ear infections, not having undergone surgery
Key exclusion criteria (5 listed)
- Having cognitive dysfunction
- Presence of temporal bone pathologies detected by magnetic resonance imaging
- Presence of other inner ear disorders that may cause dizziness and imbalance as determined by audiogram, tympanogram, and acoustic reflexes
- Previous lower extremity injuries
- The presence of central findings in Videonystagmography results
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 rehabilitation consisted of a total of 12 sessions, rearranged every 15 days. These exercises were prepared gradually to increase the vestibulo-ocular reflex and vestibulospinal reflex. The following exercises were done with the patients: vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The therapist gave the patients a home exercise program. It was emphasized that the exercises should be applied as 10 repetitions. After the session, the exercises shown to the patients were explained in written form and given as home exercises. They were also asked to do home exercises 3 times a day, 10 repetitions, for 15 days. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month. | Other | vestibular rehabilitation group |
Primary outcome
Change from Baseline Static Posture Evaluation at 6 Months (Limits of Stability and modified for Sensory Interaction in Balance Clinical Test )
Time frame: 6 months
With the limits of stability program on the balance device called Otometrics ICS Balance Platform, the body's final reaching points, the speed of movement, and direct control were evaluated, in 8 directions. Within this device, the modified for Sensory Interaction in Balance Clinical Test test was evaluated by showing areas of oscillation. Modified-CTSIB is a clinical test that is generally used as a semi-quantitative test measurement, and is scored according to the person's ability to perform various standing static positions.Before removing the patient on the device, the center of gravity is determined by entering the height and weight, and the patient visually sees the center of gravity when he/she gets on the balance platform. Then all tests are done according to this center of gravity.
Change from Baseline Dizziness Handicap Inventory at 6 Months
Time frame: 6 months
Dizziness Handicap Inventory was used to evaluate the quality of life of patients. This scale consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases.
3 secondary outcomes
Results of Dynamic Visual Acuity, Subjective Visual
Time frame: 6 months
Results of Dizziness Severity Scale, Subjective Visual
Time frame: 6 month
Results of Tandem, Semi-tandem, Romberg and One-Leg Stance Test, Subjective Visual
Time frame: 6 months
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 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Individuals With Vestibular Hypofunction
Recruiting
Vibrotactile Balance Belt Effect on Improving Gait
Vestibular Hypofunction, Ataxia - Other
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.
Gamze Kılıç, master principal investigator
PhD student
Z. Candan Algun, professor study director
head of physical medicine and rehabilitaton department
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 Individuals With Vestibular Hypofunction and Individuals Between the Ages of 18-65, 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 5 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 9 Feb 2022. 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 from Baseline Static Posture Evaluation at 6 Months (Limits of Stability and modified for Sensory Interaction in Balance Clinical Test ) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 9 Feb 2022.