Vertigo, PeripheralNCT04687371
The Effect of Proprioseptive Vestibular Rehabilitation in Patients With Peripheral Vestibular Hypofunction
A study testing Proprioceptive vestibular exercise and Standard vestibular rehabilitation exercises in people with Vertigo, Peripheral and Vestibular Disease, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life in patients with vertigo due to peripheral vestibular hypofunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vertigo, Peripheral, Vestibular Disease
- What is being tested?
- Proprioceptive vestibular exercise and Standard vestibular rehabilitation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 25 Jun 2021
- 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
- Between 18-65 years
- Diagnosis of vertigo according to the clinical examination performed by an Otorhinolaryngologist, Vestibular Evoked Myogenic Potentials (VEMP), Video Head Impulse Test (VHIT)
- Patients with Unilateral Peripheral Hypofunction
- After giving detailed information about the research, agreeing to participate in the study.
Who cannot join
- Severe hearing / vision impairment-loss
- Patients with neurological, orthopedic, circulatory system problems that may cause vertigo, dizziness and balance disorders
- Having severe hypertension / diabetes
- Previous participation in a vestibular rehabilitation program
- Being healthy
- Patients using drugs that may affect the treatment negatively
Show all 10Show fewer
- Refusing to participate in a clinical trial
- Patients who cannot adapt to the training program
- Patients who discontinued their treatment
- Patients with different diagnoses that may disrupt the treatment during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University
Malatya, Battalgazi/MALATYA, 44280
About this study
Official title: The Effect of Proprioseptive Vestibular Rehabilitation on the Balance, Functional Mobility, Posture, Sensory Profile and Quality of Life in Patients With Vertigo Due to Peripheral Vestibular Hypofunction
The aim of this study was to investigate the effect of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life in patients with vertigo due to peripheral vestibular hypofunction.
Read the detailed description
Peripheral vestibular system; It forms the part extending from the structures in the inner ear to the vestibular nuclei in the brainstem. Peripheral vestibular hypofunction is a chronic disease affecting one or both sides of the vestibular system, which occurs when the function of the vestibular organs, vestibular nerve, or both is reduced or destroyed. Many patients with peripheral vestibular hypofunction develop symptoms such as dizziness, vertigo, imbalance, gait disturbance. Many different exercise methods have been tried so far to relieve these symptoms and increase the functionality of the patient. In this study, we aimed to examine the effect of proprioceptive vestibular rehabilitation on balance, quality of life, posture, sensory profile and functional mobility in patients with vertigo due to peripheral vestibular hypofunction aged 18-65 years. Patients with vertigo due to peripheral vestibular hypofunction between the ages of 18-65 will be included in our study. The population of the research will be created by the cluster sampling method and the randomization of the patients to be recruited will be determined using the "research ramdomizer" computer program; Patients will be divided into 3 groups as experimental and control groups. A randomized controlled, single-blind study will be planned. Group I (experiment): Glance stabilization exercises, Cawthorne Cooksey Exercises and Proprioceptive vestibular rehabilitation exercises, Group II (experiment): Glance stabilization exercises and Cawthorne Cooksey Exercises and Group III (control): no exercise will be given, they will be asked to continue daily life. Exercises will be applied to each group for 8 weeks, 4 days a week, 30 minutes, in the presence of 1 set of physiotherapists and as a home exercise program every day of the week. Individuals will be evaluated before and 8 weeks after the treatment. Tinetti Balance Test for balance assessment, One leg stand test; timed up and go test for functional mobility assessment; Dizziness Disability Inventory for quality of life; mobile posture assessment application for posture assessment; Adult / Adolescent Sensory profile will be used for sensory assessment. Pre- and post-treatment and intergroup evaluations will be compared, and the effectiveness of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life, and its superiority over standard exercises will be interpreted.
- Conditions
- Vertigo, Peripheral, Vestibular Disease
- Being tested
- Proprioceptive vestibular exercise, Standard vestibular rehabilitation exercises, Controlled
- Keywords
- Vertigo, Peripheral Vestibular Hypofunction, Exercises, Balance, Functional Mobility, Quality of Life
- Medical subject headings
- Vertigo, Vestibular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive vestibular exerciseOther
Also called Cawthorne cooksey exercises, Gaze stabilization exercises
To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions
Standard vestibular rehabilitation exercisesOther
Also called Cawthorne Cooksey Exercises, Gaze Stabilization Exercises
To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions
ControlledOther
First and last measurement will be taken. There will be no intervention. study will include 9 patients.
| Study group | Role | What they receive |
|---|---|---|
| Grup I | Experimental | Proprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises, Receives: Other: Proprioceptive vestibular exercise |
| Grup II | Experimental | Cawthorne Cooksey Exercises and Gaze Stabilization exercises Receives: Other: Standard vestibular rehabilitation exercises |
| Grup III | Other | No intervention will be made, patients will be asked to continue their daily life Receives: Other: Controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness handicap inventory
It used to assess the quality of life in patients with vertigo
Measured: 8 weeks
Tinetti balance test
It used to asses the balance (questionnaire, score)
Measured: 8 weeks
Time up and go test
It used to assses the functionality (sec)
Measured: 8 weeks
Adolescent/Adult Sensory Profile
In the test, 6 different sensory processing processes are evaluated. Includes assessments of taste/smell process, movement process, visual processing, touch process, activity level and auditory processing. Each item is scored with likert measurements between 1 and 5 points determined by the person.
Measured: 8 weeks
Mobile application for Posture Analyze
It used to assess Posture (Degree)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start10 Feb 2021
- Primary completion18 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vertigo, PeripheralStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Model description
- Experimental, Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu TALU, Assoc. Prof., Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687371
- Sponsor's protocol ID
- 2020/190
- Status last verified
- Feb 2021
- First submitted
- 18 Dec 2020
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozaltin GE, Simsek A, Candiri B, Algul FE, Tecellioglu M, Talu B. Assessment of balance, sleep quality, and depression in relation to attention in Parkinson's disease: A cross-sectional P300 study. Sao Paulo Med J. 2026 Jul 17;144(3):e20253465. doi: 10.1590/1516-3180.2026.3465.10032026. eCollection 2026.
PubMed 42484116Ozaltin GE, Talu B, Bayindir T. The effect of proprioceptive vestibular rehabilitation on sensory-motor symptoms and quality of life. Arq Neuropsiquiatr. 2024 Nov;82(11):1-10. doi: 10.1055/s-0044-1790568. Epub 2024 Sep 24.
PubMed 39317226
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proprioseptive Vestibular Rehabilitation on the Balance, Functional Mobility, Posture, Sensory Profile and Quality of Life in Patients With Vertigo Due to Peripheral Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT04687371
- Acronym / sponsor ID
- 2020/190
- Conditions
- Vertigo, Peripheral, Vestibular Disease
- Keywords
- Vertigo, Peripheral Vestibular Hypofunction, Exercises, Balance, Functional Mobility, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 29 Dec 2020 (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 the effect of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life in patients with vertigo due to peripheral vestibular hypofunction.
Detailed description
Peripheral vestibular system; It forms the part extending from the structures in the inner ear to the vestibular nuclei in the brainstem. Peripheral vestibular hypofunction is a chronic disease affecting one or both sides of the vestibular system, which occurs when the function of the vestibular organs, vestibular nerve, or both is reduced or destroyed. Many patients with peripheral vestibular hypofunction develop symptoms such as dizziness, vertigo, imbalance, gait disturbance. Many different exercise methods have been tried so far to relieve these symptoms and increase the functionality of the patient. In this study, we aimed to examine the effect of proprioceptive vestibular rehabilitation on balance, quality of life, posture, sensory profile and functional mobility in patients with vertigo due to peripheral vestibular hypofunction aged 18-65 years. Patients with vertigo due to peripheral vestibular hypofunction between the ages of 18-65 will be included in our study. The population of the research will be created by the cluster sampling method and the randomization of the patients to be recruited will be determined using the "research ramdomizer" computer program; Patients will be divided into 3 groups as experimental and control groups. A randomized controlled, single-blind study will be planned. Group I (experiment): Glance stabilization exercises, Cawthorne Cooksey Exercises and Proprioceptive vestibular rehabilitation exercises, Group II (experiment): Glance stabilization exercises and Cawthorne Cooksey Exercises and Group III (control): no exercise will be given, they will be asked to continue daily life. Exercises will be applied to each group for 8 weeks, 4 days a week, 30 minutes, in the presence of 1 set of physiotherapists and as a home exercise program every day of the week. Individuals will be evaluated before and 8 weeks after the treatment. Tinetti Balance Test for balance assessment, One leg stand test; timed up and go test for functional mobility assessment; Dizziness Disability Inventory for quality of life; mobile posture assessment application for posture assessment; Adult / Adolescent Sensory profile will be used for sensory assessment. Pre- and post-treatment and intergroup evaluations will be compared, and the effectiveness of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life, and its superiority over standard exercises will be interpreted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Experimental, Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Grup I | Experimental | Other: Proprioceptive vestibular exerciseProprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises, |
| Grup II | Experimental | Other: Standard vestibular rehabilitation exercisesCawthorne Cooksey Exercises and Gaze Stabilization exercises |
| Grup III | Other | Other: ControlledNo intervention will be made, patients will be asked to continue their daily life |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18-65 years
- Diagnosis of vertigo according to the clinical examination performed by an Otorhinolaryngologist, Vestibular Evoked Myogenic Potentials (VEMP), Video Head Impulse Test (VHIT)
- Patients with Unilateral Peripheral Hypofunction
- After giving detailed information about the research, agreeing to participate in the study.
Key exclusion criteria (10 listed)
- Severe hearing / vision impairment-loss
- Patients with neurological, orthopedic, circulatory system problems that may cause vertigo, dizziness and balance disorders
- Having severe hypertension / diabetes
- Previous participation in a vestibular rehabilitation program
- Being healthy
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 |
|---|---|---|
| Proprioceptive vestibular exerciseAlso: Cawthorne cooksey exercises, Gaze stabilization exercisesTo assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions | Other | Grup I |
| Standard vestibular rehabilitation exercisesAlso: Cawthorne Cooksey Exercises, Gaze Stabilization ExercisesTo assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions | Other | Grup II |
| ControlledFirst and last measurement will be taken. There will be no intervention. study will include 9 patients. | Other | Grup III |
Primary outcome
Dizziness handicap inventory
Time frame: 8 weeks
It used to assess the quality of life in patients with vertigo
Tinetti balance test
Time frame: 8 weeks
It used to asses the balance (questionnaire, score)
Time up and go test
Time frame: 8 weeks
It used to assses the functionality (sec)
Adolescent/Adult Sensory Profile
Time frame: 8 weeks
In the test, 6 different sensory processing processes are evaluated. Includes assessments of taste/smell process, movement process, visual processing, touch process, activity level and auditory processing. Each item is scored with likert measurements between 1 and 5 points determined by the person.
Mobile application for Posture Analyze
Time frame: 8 weeks
It used to assess Posture (Degree)
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 19 Apr 2022.
- Derived from this study: PubMed 42484116Ozaltin GE, Simsek A, Candiri B, Algul FE, Tecellioglu M, Talu B. Assessment of balance, sleep quality, and depression in relation to attention in Parkinson's disease: A cross-sectional P300 study. Sao Paulo Med J. 2026 Jul 17;144(3):e20253465. doi: 10.1590/1516-3180.2026.3465.10032026. eCollection 2026.
- Derived from this study: PubMed 39317226Ozaltin GE, Talu B, Bayindir T. The effect of proprioceptive vestibular rehabilitation on sensory-motor symptoms and quality of life. Arq Neuropsiquiatr. 2024 Nov;82(11):1-10. doi: 10.1055/s-0044-1790568. Epub 2024 Sep 24.
- 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.
Burcu TALU, Assoc. Prof. principal investigator
Inonu 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 Proprioceptive vestibular exercise and Standard vestibular rehabilitation exercises in people with Vertigo, Peripheral and Vestibular Disease, run by Inonu University 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 10 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 19 Apr 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?
Dizziness handicap inventory (time frame: 8 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 NCT04687371, which also lists 2 linked publications.
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 19 Apr 2022.