- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04687371
The Effect of Proprioseptive Vestibular Rehabilitation in Patients With Peripheral Vestibular Hypofunction
April 18, 2022 updated by: Burcu Talu, Inonu University
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.
Study Overview
Status
Completed
Conditions
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 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
-
-
Battalgazi/MALATYA
-
Malatya, Battalgazi/MALATYA, Turkey, 44280
- Inonu University
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Grup I
Proprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises,
|
To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions
Other Names:
|
Experimental: Grup II
Cawthorne Cooksey Exercises and Gaze Stabilization exercises
|
To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions
Other Names:
|
Other: Grup III
No intervention will be made, patients will be asked to continue their daily life
|
First and last measurement will be taken.
There will be no intervention.
study will include 9 patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dizziness handicap inventory
Time Frame: 8 weeks
|
It used to assess the quality of life in patients with vertigo
|
8 weeks
|
Tinetti balance test
Time Frame: 8 weeks
|
It used to asses the balance (questionnaire, score)
|
8 weeks
|
Time up and go test
Time Frame: 8 weeks
|
It used to assses the functionality (sec)
|
8 weeks
|
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.
|
8 weeks
|
Mobile application for Posture Analyze
Time Frame: 8 weeks
|
It used to assess Posture (Degree)
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Burcu TALU, Assoc. Prof., Inonu University
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 10, 2021
Primary Completion (Actual)
June 18, 2021
Study Completion (Actual)
June 25, 2021
Study Registration Dates
First Submitted
December 18, 2020
First Submitted That Met QC Criteria
December 23, 2020
First Posted (Actual)
December 29, 2020
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 18, 2022
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/190
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
product manufactured in and exported from the U.S.
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.
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