Vestibular DisorderNCT05430282
Cervical Exercise in Peripheral Vestibular Disorders
A study testing Only vestibular rehabilitation and Cervical exercises in addition to vestibular rehabilitation in people with Vestibular Disorder and Peripheral Vestibular Disorder, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
70 patients with peripheral vestibular disorders will be included in the study. Half of the subjects will receive vestibular rehabilitation exercises and the other half will receive additional cervical exercises. Results from the two groups will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Disorder, Peripheral Vestibular Disorder
- What is being tested?
- Only vestibular rehabilitation and Cervical exercises in addition to vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2022to 22 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of peripheral vestibular disease
- Being older than 18 years of age
Who cannot join
- Psychostimulant or psychotropic drug use that might alter vestibular functions
- Severe neurological, psychiatric or orthopedic disorder that might alter patients' ability to comply with the exercise program.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine
Bornova, İzmir, 35100
About this study
Official title: Effect of Cervical Exercises in Addition to Vestibular Rehabilitation in the Treatment of Peripheral Vestibular Disorders
70 patients with peripheral vestibular disorders will be included in the study. Half of the subjects will receive vestibular rehabilitation exercises and the other half will receive additional cervical exercises. Results from the two groups will be compared.
Read the detailed description
70 patients with a diagnosis of peripheral vestibular disease will be enrolled in the study. Patient selection will be carried out in the physiatry, otorhinolaryngology and neurology outpatient clinics of our university hospital. Eligible patients will be informed about the study and those that accept to take part in the study will be referred to an investigator for history taking and physical examination. Demographic data, medical history and examination findings will be recorded. After initial assessment, all patients will receive a short education regarding vestibular exercises that they will be asked to do at home. A second investigator will be responsible for the randomization of subjects into two groups according to a computer generated randomization table and that same investigator will prescribe the second group additional cervical exercises to do in addition to the vestibular rehabilitation exercises.
After one months, patients will be reassessed and their measurements will be recorded. Statistical analyses will be carried out to compare the outcome scores of the two groups.
- Being tested
- Only vestibular rehabilitation, Cervical exercises in addition to vestibular rehabilitation
- Keywords
- vestibular disorders, cervical exercises, vertigo, vestibular exercises
- 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.
Only vestibular rehabilitationOther
Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.
Cervical exercises in addition to vestibular rehabilitationOther
Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular rehabilitation | Active comparator | Patients in the vestibular rehabilitation group will be asked to do vestibular exercises 3 times a day for 20 minutes, every day for one month. Receives: Other: Only vestibular rehabilitation; Other: Cervical exercises in addition to vestibular rehabilitation |
| Cervical exercise in addition to vestibular rehabilitation | Experimental | Patients in this group will receive the same vestibular exercise program and will be asked to do additional neck exercises and they will be asked to do these exercises twice a day for ten minutes. Receives: Other: Cervical exercises in addition to vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks
A questionnaire that measures an individual's confidence during ambulatory activities. The scale is scored from 0 to 100. 100 indicates better outcome.
Measured: Baseline and 4th week visit
Change from baseline Dizziness handicap inventory at 4 weeks
A 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. The scale is scored from 0 to 100. 100 indicates better outcome.
Measured: Baseline and 4th week visit
Change from baseline Gait speed at 4 weeks
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. Gait speed has different reference values according to age and sex.
Measured: Baseline and 4th week visit
Change from baseline Dynamic gait index at 4 weeks
An inventory that assesses individual's ability to modify balance while walking in the presence of external demands. Highest possible score is 24 points and lower scores indicate worse outcome.
Measured: Baseline and 4th week visit
Change from baseline Functional gait assessment at 4 weeks
An index that is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Highest score is 30 points and higher scores denote better outcome.
Measured: Baseline and 4th week visit
Change from baseline Romberg test at 4 weeks
A balance test that challenges the vestibular, proprioceptive and visual systems. Subject is asked to stand erect with eyes open/closed, on a hard/smooth surface and with feet side by side/ in tandem.Normally a person is expected to be able to stand in these positions for 30 seconds.
Measured: Baseline and 4th week visit
Secondary outcomes (2)
Change from baseline Visual analog scale for neck pain at 4 weeks
Patient reported level of neck pain on a scale from 0 to 10 centimeters. 10 denotes severe pain and 0 denotes lack of pain.
Measured: Baseline and 4th week visit
Change from baseline Visual analog scale for dizziness at 4 weeks
Patient reported level of dizziness on a scale from 0 to 10 centimeters. 10 indicates severe dizziness.
Measured: Baseline and 4th week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start25 Jun 2022
- Primary completion25 Oct 2022
- Study completion22 Dec 2022
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 Vestibular DisorderStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Cinar, Ege University
- Investigators
- Yesim Kirazli, Prof, Study chair, Ege University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430282
- Sponsor's protocol ID
- 19-9.1Y/54
- Status last verified
- Jan 2023
- First submitted
- 12 Jun 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
PubMed 30947180Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.
PubMed 30461465
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Exercises in Addition to Vestibular Rehabilitation in the Treatment of Peripheral Vestibular Disorders
- ClinicalTrials.gov ID
- NCT05430282
- Acronym / sponsor ID
- 19-9.1Y/54
- Keywords
- vestibular disorders, cervical exercises, vertigo, vestibular exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 24 Jun 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.
70 patients with peripheral vestibular disorders will be included in the study. Half of the subjects will receive vestibular rehabilitation exercises and the other half will receive additional cervical exercises. Results from the two groups will be compared.
Detailed description
70 patients with a diagnosis of peripheral vestibular disease will be enrolled in the study. Patient selection will be carried out in the physiatry, otorhinolaryngology and neurology outpatient clinics of our university hospital. Eligible patients will be informed about the study and those that accept to take part in the study will be referred to an investigator for history taking and physical examination. Demographic data, medical history and examination findings will be recorded. After initial assessment, all patients will receive a short education regarding vestibular exercises that they will be asked to do at home. A second investigator will be responsible for the randomization of subjects into two groups according to a computer generated randomization table and that same investigator will prescribe the second group additional cervical exercises to do in addition to the vestibular rehabilitation exercises.
After one months, patients will be reassessed and their measurements will be recorded. Statistical analyses will be carried out to compare the outcome scores of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular rehabilitation | Active comparator | Other: Only vestibular rehabilitation, Other: Cervical exercises in addition to vestibular rehabilitationPatients in the vestibular rehabilitation group will be asked to do vestibular exercises 3 times a day for 20 minutes, every day for one month. |
| Cervical exercise in addition to vestibular rehabilitation | Experimental | Other: Cervical exercises in addition to vestibular rehabilitationPatients in this group will receive the same vestibular exercise program and will be asked to do additional neck exercises and they will be asked to do these exercises twice a day for ten minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of peripheral vestibular disease
- Being older than 18 years of age
Key exclusion criteria (2 listed)
- Psychostimulant or psychotropic drug use that might alter vestibular functions
- Severe neurological, psychiatric or orthopedic disorder that might alter patients' ability to comply with the exercise program.
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 |
|---|---|---|
| Only vestibular rehabilitationVestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises. | Other | Vestibular rehabilitation |
| Cervical exercises in addition to vestibular rehabilitationCervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises. | Other | Cervical exercise in addition to vestibular rehabilitation, Vestibular rehabilitation |
Primary outcome
Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks
Time frame: Baseline and 4th week visit
A questionnaire that measures an individual's confidence during ambulatory activities. The scale is scored from 0 to 100. 100 indicates better outcome.
Change from baseline Dizziness handicap inventory at 4 weeks
Time frame: Baseline and 4th week visit
A 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. The scale is scored from 0 to 100. 100 indicates better outcome.
Change from baseline Gait speed at 4 weeks
Time frame: Baseline and 4th week visit
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. Gait speed has different reference values according to age and sex.
Change from baseline Dynamic gait index at 4 weeks
Time frame: Baseline and 4th week visit
An inventory that assesses individual's ability to modify balance while walking in the presence of external demands. Highest possible score is 24 points and lower scores indicate worse outcome.
Change from baseline Functional gait assessment at 4 weeks
Time frame: Baseline and 4th week visit
An index that is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Highest score is 30 points and higher scores denote better outcome.
Change from baseline Romberg test at 4 weeks
Time frame: Baseline and 4th week visit
A balance test that challenges the vestibular, proprioceptive and visual systems. Subject is asked to stand erect with eyes open/closed, on a hard/smooth surface and with feet side by side/ in tandem.Normally a person is expected to be able to stand in these positions for 30 seconds.
2 secondary outcomes
Change from baseline Visual analog scale for neck pain at 4 weeks
Time frame: Baseline and 4th week visit
Change from baseline Visual analog scale for dizziness at 4 weeks
Time frame: Baseline and 4th week visit
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 Jan 2023.
- Background: PubMed 30947180Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
- Background: PubMed 30461465Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.
- 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.
Yesim Kirazli, Prof study chair
Ege University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Only vestibular rehabilitation and Cervical exercises in addition to vestibular rehabilitation in people with Vestibular Disorder and Peripheral Vestibular Disorder, run by Ege 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 2 inclusion and 2 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 Jan 2023. 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 The activities-specific balance confidence (ABC) scale at 4 weeks (time frame: Baseline and 4th week visit). The study lists 6 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 NCT05430282, 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 18 Jan 2023.