Vestibular DiseasesNCT06563076
Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation
A study testing Vestibular Rehabilitation and Vestibular Electrical Stimulation in people with Vestibular Diseases and Vestibular Disorder, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effectiveness of the vestibular rehabilitation program applied to patients with chronic unilateral vestibular hypofunction and the vestibular electrical stimulation applied to the trapezius muscles and cervical paravertebral muscles along with the rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vestibular Diseases, Vestibular Disorder, Vestibular Vertigo
- What is being tested?
- Vestibular Rehabilitation and Vestibular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Patients who were evaluated by a Neurologist, Physical Medicine and Rehabilitation Specialist and otorhinolaryngologist and diagnosed with chronic unilateral vestibular hypofunction and have findings of chronic unilateral vestibular hypofunction
- Patients whose VOR gain for any unilateral semicircular canal based on vHIT test is below 0.7
- Patients who volunteered to participate in the study and signed the consent forms
Who cannot join
- Existing neurological or mental disorders
- Patients using vestibulosuppressant drugs
- Stroke, head trauma and other neurological diseases
- Patients with a history of brain surgery
- Patients with severely limited neck joint range of motion (those with a limitation of 45 degrees or more)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Çankaya, 06800
About this study
Official title: Evaluation of the Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation
This study aimed to evaluate the effectiveness of the vestibular rehabilitation program applied to patients with chronic unilateral vestibular hypofunction and the vestibular electrical stimulation applied to the trapezius muscles and cervical paravertebral muscles along with the rehabilitation program.
Read the detailed description
This study included 40 patients with unilateral vestibular hypofunction findings, aged between 18 and 65, and whose unilateral vestibulo-ocular reflex (VOR) gain for any semicircular canal was below 0.7 based on the video head impulse test (vHIT) test, were randomized into two groups. While one group underwent a supervised vestibular rehabilitation program for 4 weeks, the other group received 80 Hz high frequency transcutaneous vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program. The treatment was applied to each group, 3 days a week, for a total of 12 sessions. Detailed musculoskeletal system examinations and vestibular system examinations of the included patients were performed, and sociodemographic characteristics (age, gender, body mass index (BMI), education level) were recorded. Both groups were tested before treatment and at the end of the 4th week, Dizziness Disability Inventory (DHI), Visual Analogue Scale (VAS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Activity-Specific Balance and Confidence Scale (ABCs), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and Static Posturography.
- Conditions
- Vestibular Diseases, Vestibular Disorder, Vestibular Vertigo
- Being tested
- Vestibular Rehabilitation, Vestibular Electrical Stimulation
- Keywords
- Vertigo, Rehabilitation, TENS
- Medical subject headings
- Vestibular Diseases, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationOther
supervised vestibular rehabilitation program
Vestibular Electrical StimulationOther
80 Hz high frequency transcutaneous vestibular electrical stimulation (VES)
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation Group | Active comparator | underwent vestibular rehabilitation program Receives: Other: Vestibular Rehabilitation |
| Vestibular Rehabilitation and Vestibular Electrical Stimulation Group | Active comparator | underwent vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program. Receives: Other: Vestibular Rehabilitation; Other: Vestibular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
'Dizziness Handicap Inventory (DHI)' consists of 25 items that determine the functional and sensory consequences of vestibular system diseases as well as the factors that aggravate dizziness and balance disorders.
Questions 1, 4, 8, 11, 13, 17 and 25 of the scale are structured to measure physical disability; questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 are structured to measure emotional disability; questions 3, 5, 6, 7, 12, 14, 16, 19 and 24 are structured to measure functional disability. Each question is scored as yes (4 points), no (0 points) and sometimes (2 points). The level of disability can be categorized according to the scale: 16-34 points = mild disability; 36-52 points = moderate disability; 54+ points = severe disability
Measured: Baseline and after 4 weeks
Secondary outcomes (7)
Dizziness Severity Visual Analog Scale
Dizziness Severity: Using the Visual Analog Scale (VAS), patients are asked to indicate the severity of dizziness they have felt in the last week on a 10-centimeter chart. 0: no symptoms, 10: symptoms are evaluated as very severe.
Measured: Baseline and after 4 weeks
Timed Up and Go Test
Functional mobility and fall risk in patients are assessed with a timed up and go test. Patients were asked to get up from a standard arm chair, walk a distance of three meters, come back and sit down, and the time was calculated in seconds. When the timed up and go test is completed in more than 12 seconds, the risk of falling is considered to be increased.
Measured: Baseline and after 4 weeks
Berg Balance Score
The "Berg Balance Scale" is used to determine the risk of falling in patients. It is a scale that shows whether patients can maintain their balance while performing 14 different tasks. It includes tasks such as sitting without support, standing up without support, standing in tandem, sitting down while standing, picking up objects from the floor, looking back while standing, standing on one leg, standing with eyes closed. Scoring is between 0 (cannot do) and 4 (safely do). The maximum score is 56.
Measured: Baseline and after 4 weeks
Activity Specific Balance and Confidence Scale
The confidence that patients feel during their daily living activities at home and in the community is assessed with the "Activity Specific Balance and Confidence Scale (ABC)". It consists of 16 questions and each question is given a score between 0 (I have no confidence) and 100 (I have full confidence). All scores are added up and divided by 16 to obtain the main score. The risk of falling increases at 67 points and below. Home dependency increases at 50 points and below. A score between 50 and 80 indicates moderate limitation, and a score of 80 and above indicates community activity.
Measured: Baseline and after 4 weeks
Beck Depression Inventory
The Beck Depression Inventory is used to identify the risk of depression in adults and to measure changes in the severity and level of depression symptoms. It consists of 21 questions about depression symptoms, two about emotions, eleven about cognitive symptoms, two about behaviors, five about physical symptoms, and one about interpersonal symptoms. Each question is scored from 0 to 3, resulting in a total score of 0 to 63.
Measured: Baseline and after 4 weeks
Beck Anxiety Inventory
It is designed to measure the severity of anxiety symptoms experienced by individuals. Subjective anxiety and physical symptoms are questioned. It is a self-report scale consisting of 21 items and scored between 0 and 3 based on a Likert scale. The total score ranges from 0 to 63. Higher total scores indicate more severe levels of anxiety experienced by the individual.
Measured: Baseline and after 4 weeks
Static Posturography
The ''Limits of Stability'' (LOS) test, which measures the maximum limit at which people can stand in order to remain stable in order to maintain balance when leaning in certain directions, is evaluated with the Hur Smart Balance Static Posturography device. This protocol is used to test the stability limits of the person in four directions. The tested person stands in the positions of leaning forward, leaning back, leaning left and leaning right, respectively, from the normal standing position. As a result of the measurements, the LOS values of each evaluation are recorded by the device.
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Burak Bayraklı, Ankara City Hospital Bilkent
- Investigators
- Bilal Burak Bayraklı, M.D, Principal investigator, Ankara City Hospital BilkentÖmer Kuzu, M.D, Study chair, Ankara City Hospital BilkentCanan Çelik, Professor, Study director, Ankara City Hospital BilkentÖzlem Öztürk Tan, M.D, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563076
- Sponsor's protocol ID
- E2-22-2962
- Other IDs
- 10026336
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation
- ClinicalTrials.gov ID
- NCT06563076
- Acronym / sponsor ID
- E2-22-2962
- Conditions
- Vestibular Diseases, Vestibular Disorder, Vestibular Vertigo
- Keywords
- Vertigo, Rehabilitation, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Aug 2024 (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.
This study aimed to evaluate the effectiveness of the vestibular rehabilitation program applied to patients with chronic unilateral vestibular hypofunction and the vestibular electrical stimulation applied to the trapezius muscles and cervical paravertebral muscles along with the rehabilitation program.
Detailed description
This study included 40 patients with unilateral vestibular hypofunction findings, aged between 18 and 65, and whose unilateral vestibulo-ocular reflex (VOR) gain for any semicircular canal was below 0.7 based on the video head impulse test (vHIT) test, were randomized into two groups. While one group underwent a supervised vestibular rehabilitation program for 4 weeks, the other group received 80 Hz high frequency transcutaneous vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program. The treatment was applied to each group, 3 days a week, for a total of 12 sessions. Detailed musculoskeletal system examinations and vestibular system examinations of the included patients were performed, and sociodemographic characteristics (age, gender, body mass index (BMI), education level) were recorded. Both groups were tested before treatment and at the end of the 4th week, Dizziness Disability Inventory (DHI), Visual Analogue Scale (VAS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Activity-Specific Balance and Confidence Scale (ABCs), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and Static Posturography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Group | Active comparator | Other: Vestibular Rehabilitationunderwent vestibular rehabilitation program |
| Vestibular Rehabilitation and Vestibular Electrical Stimulation Group | Active comparator | Other: Vestibular Rehabilitation, Other: Vestibular Electrical Stimulationunderwent vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
- Patients who were evaluated by a Neurologist, Physical Medicine and Rehabilitation Specialist and otorhinolaryngologist and diagnosed with chronic unilateral vestibular hypofunction and have findings of chronic unilateral vestibular hypofunction
- Patients whose VOR gain for any unilateral semicircular canal based on vHIT test is below 0.7
- Patients who volunteered to participate in the study and signed the consent forms
Key exclusion criteria (5 listed)
- Existing neurological or mental disorders
- Patients using vestibulosuppressant drugs
- Stroke, head trauma and other neurological diseases
- Patients with a history of brain surgery
- Patients with severely limited neck joint range of motion (those with a limitation of 45 degrees or more)
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 Rehabilitationsupervised vestibular rehabilitation program | Other | Vestibular Rehabilitation Group, Vestibular Rehabilitation and Vestibular Electrical Stimulation Group |
| Vestibular Electrical Stimulation80 Hz high frequency transcutaneous vestibular electrical stimulation (VES) | Other | Vestibular Rehabilitation and Vestibular Electrical Stimulation Group |
Primary outcome
Dizziness Handicap Inventory
Time frame: Baseline and after 4 weeks
'Dizziness Handicap Inventory (DHI)' consists of 25 items that determine the functional and sensory consequences of vestibular system diseases as well as the factors that aggravate dizziness and balance disorders. Questions 1, 4, 8, 11, 13, 17 and 25 of the scale are structured to measure physical disability; questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 are structured to measure emotional disability; questions 3, 5, 6, 7, 12, 14, 16, 19 and 24 are structured to measure functional disability. Each question is scored as yes (4 points), no (0 points) and sometimes (2 points). The level of disability can be categorized according to the scale: 16-34 points = mild disability; 36-52 points = moderate disability; 54+ points = severe disability
7 secondary outcomes
Dizziness Severity Visual Analog Scale
Time frame: Baseline and after 4 weeks
Timed Up and Go Test
Time frame: Baseline and after 4 weeks
Berg Balance Score
Time frame: Baseline and after 4 weeks
Activity Specific Balance and Confidence Scale
Time frame: Baseline and after 4 weeks
Beck Depression Inventory
Time frame: Baseline and after 4 weeks
Beck Anxiety Inventory
Time frame: Baseline and after 4 weeks
Static Posturography
Time frame: Baseline and after 4 weeks
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 21 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Bilal Burak Bayraklı, M.D principal investigator
Ankara City Hospital Bilkent
Ömer Kuzu, M.D study chair
Ankara City Hospital Bilkent
Canan Çelik, Professor study director
Ankara City Hospital Bilkent
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 and Vestibular Electrical Stimulation in people with Vestibular Diseases and Vestibular Disorder, run by Ankara City Hospital Bilkent 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 4 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 21 Aug 2024. 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?
Dizziness Handicap Inventory (time frame: Baseline and after 4 weeks). 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 21 Aug 2024.