Individuals With Vestibular HypofunctionNCT05070936
The Effect Of Vestibular Rehabilitation On Kinesiophobia And Balance With Individuals Who Has 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
Vestibular hypofunction is a disease which emerge through a partial or total loss on a vestibular organ or vestibular nerve. It can be seen unilateral or bilateral. Aim of the study is to examine effects of vestibular rehabilitation on kinesiophobia, quality of life, dynamic vision acuity and balance. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2020to 2 Apr 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
- Individuals with vestibular hypofunction diagnosed by videonystagmography test
- Patients aged between 18-65 years.
Who cannot join
- Patients with visual impairment and neurological involvement
- Individuals with wavy vertigo
- Ataxia, or other lesions causing oscillopsia
- Dementia
- Patients with severely limited mobility and unable to walk without using a walker, cane, or orthosis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Güneşli Erdem Hastanesi
Bağcılar, Güneşli, 34200
About this study
Official title: Effect Of Vestibular Rehabilitation On Kinesiophobia, Quality Of Life, Dynamic Visual Acuity And Balance With Individuals Who Has Vestibular Hypofunction
Vestibular hypofunction is a disease which emerge through a partial or total loss on a vestibular organ or vestibular nerve. It can be seen unilateral or bilateral. Aim of the study is to examine effects of vestibular rehabilitation on kinesiophobia, quality of life, dynamic vision acuity and balance. The study was conducted with patients diagnosed with vestibular hypofunction. 30 patients who are in the ages between 18 and 65 have participated in the study. Exercise programs has given to patients to do at home. Patients were observed every two weeks in the hospital. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Before and after the treatment, Tampa Kinesiophobia Scale, World Health Organization Quality of Life Scale-Short form in Turkish, Dynamic Visual Acuity Test, Balance Tests, Unterberger Test, Visual Analog Scale to measure dizziness and fatigue, for verticality and horizontality perception Subjective Visual Vertical and Subjective Visual Horizontal tests have been applied. As a result of the study, statistical correlations have been found except semi-tandem posture test with eyes open and Romberg's test both with eyes open and closed. It can be said that vestibular rehabilitation has improved quality of life, balance, dynamic vision acuity and overcame kinesiophobia on the patients.
Read the detailed description
Vestibular rehabilitation consisted of a total of 4 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: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. 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. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients.
- Being tested
- vestibular rehabilitation
- Keywords
- Balance, Dynamic visual acuity, Kinesiophobia, Vestibular hypofunction, Vestibular rehabilitation
- Medical subject headings
- Kinesiophobia
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 4 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: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. 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. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| vestibular rehabilitation group | Other | Vestibular rehabilitation was performed. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Patients were observed in the hospital every two weeks. The exercises given in the session were given as home exercises, 3 times a day, for 10 repetitions. Receives: Other: vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Before and After Tampa Kinesiophobia Scale Values
It was determined that there was a statistically significant difference between the before and after measurement values of the Tampa kinesiophobia scale dimensions.
Measured: 8 Weeks
Secondary outcomes (2)
World Health Organization Quality of Life Scale-Short form Before and After Values
It was determined that there was a statistically significant difference between the pre- and post-measurement values of the World Health Organization Quality of Life Scale-Short form dimensions.
Measured: 8 Weeks
: Results of Tandem Stance Test, Subjective Visual Vertical and Subjective Visual Horizontal Tests, Dizziness Severity and Dynamic Visual Acuity Parameters
Improvements were observed in the tandem stance test eyes open/eyes closed test Subjective Visual Vertical and Subjective Visual Horizontal test scores on sitting, hard and soft surfaces were found to be statistically significant. The mean vertigo severity (VAS) decreased from 7.15±1.36 to 1.06±2.02.It was found that there was a statistically significant difference between the pre- and post-measurement values of the visual acuity test score.
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 posted7 Oct 2021
- Study start14 Feb 2020
- Primary completion14 Sep 2020
- Study completion2 Apr 2021
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Sever, Istanbul Medipol University Hospital
- Investigators
- Ebru Sever, master, Principal investigator, master studentZ.Candan Algun, professor, Study director, head of physical medicine and rehabilitation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070936
- Sponsor's protocol ID
- E-10840098-772.02-34270
- Status last verified
- Sep 2024
- First submitted
- 6 Oct 2021
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Vestibular Rehabilitation On Kinesiophobia, Quality Of Life, Dynamic Visual Acuity And Balance With Individuals Who Has Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT05070936
- Acronym / sponsor ID
- E-10840098-772.02-34270
- Keywords
- Balance, Dynamic visual acuity, Kinesiophobia, Vestibular hypofunction, Vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 7 Oct 2021 (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.
Vestibular hypofunction is a disease which emerge through a partial or total loss on a vestibular organ or vestibular nerve. It can be seen unilateral or bilateral. Aim of the study is to examine effects of vestibular rehabilitation on kinesiophobia, quality of life, dynamic vision acuity and balance. The study was conducted with patients diagnosed with vestibular hypofunction. 30 patients who are in the ages between 18 and 65 have participated in the study. Exercise programs has given to patients to do at home. Patients were observed every two weeks in the hospital. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Before and after the treatment, Tampa Kinesiophobia Scale, World Health Organization Quality of Life Scale-Short form in Turkish, Dynamic Visual Acuity Test, Balance Tests, Unterberger Test, Visual Analog Scale to measure dizziness and fatigue, for verticality and horizontality perception Subjective Visual Vertical and Subjective Visual Horizontal tests have been applied. As a result of the study, statistical correlations have been found except semi-tandem posture test with eyes open and Romberg's test both with eyes open and closed. It can be said that vestibular rehabilitation has improved quality of life, balance, dynamic vision acuity and overcame kinesiophobia on the patients.
Detailed description
Vestibular rehabilitation consisted of a total of 4 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: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. 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. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients.
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: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Patients were observed in the hospital every two weeks. The exercises given in the session were given as home exercises, 3 times a day, for 10 repetitions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with vestibular hypofunction diagnosed by videonystagmography test
- Patients aged between 18-65 years.
Key exclusion criteria (5 listed)
- Patients with visual impairment and neurological involvement
- Individuals with wavy vertigo
- Ataxia, or other lesions causing oscillopsia
- Dementia
- Patients with severely limited mobility and unable to walk without using a walker, cane, or orthosis.
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 4 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: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. 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. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients. | Other | vestibular rehabilitation group |
Primary outcome
Before and After Tampa Kinesiophobia Scale Values
Time frame: 8 Weeks
It was determined that there was a statistically significant difference between the before and after measurement values of the Tampa kinesiophobia scale dimensions.
2 secondary outcomes
World Health Organization Quality of Life Scale-Short form Before and After Values
Time frame: 8 Weeks
: Results of Tandem Stance Test, Subjective Visual Vertical and Subjective Visual Horizontal Tests, Dizziness Severity and Dynamic Visual Acuity Parameters
Time frame: 8 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 19 Sep 2024.
- 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.
Ebru Sever, master principal investigator
master student
Z.Candan Algun, professor study director
head of physical medicine and rehabilitation 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 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 19 Sep 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?
Before and After Tampa Kinesiophobia Scale Values (time frame: 8 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 19 Sep 2024.