- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05070936
The Effect Of Vestibular Rehabilitation On Kinesiophobia And Balance With Individuals Who Has Vestibular Hypofunction
September 16, 2024 updated by: Ebru Sever, Istanbul Medipol University Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Güneşli
-
Bağcılar, Güneşli, Turkey, 34200
- Güneşli Erdem Hastanesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals with vestibular hypofunction diagnosed by videonystagmography test
- Patients aged between 18-65 years.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: vestibular rehabilitation group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World Health Organization Quality of Life Scale-Short form Before and After Values
Time Frame: 8 Weeks
|
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.
|
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
|
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.
|
8 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ebru Sever, master, Master student
- Study Director: Z.Candan Algun, professor, head of physical medicine and rehabilitation department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2020
Primary Completion (Actual)
September 14, 2020
Study Completion (Actual)
April 2, 2021
Study Registration Dates
First Submitted
October 6, 2021
First Submitted That Met QC Criteria
October 6, 2021
First Posted (Actual)
October 7, 2021
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 16, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-34270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Individuals With Vestibular Hypofunction
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Istanbul Medipol University HospitalCompletedIndividuals With Vestibular Hypofunction | Individuals Between the Ages of 18-65Turkey
-
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