- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769323
Use of Virtual Reality Devices for Vestibular Rehabilitation
March 23, 2025 updated by: Fazıl Necdet Ardıç, Pamukkale University
Use of Virtual Reality Devices for Vestibular Rehabilitation in Patients with Vestibular Hypofunction
The aim of this study is to investigate the superiority of virtual reality-supported vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in patients with complaints such as vertigo, loss of balance, falling, and gait imbalance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
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
-
-
-
Denizli, Turkey, 20070
- Pamukkale 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
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Complaining dizziness and/or instability for more than 3 months
- Patients aged 18 and over and under 65
Exclusion Criteria:
- Ear disease, head injury
- Ototoxic drug use
- Neurological and psychiatric illness that causes cooperation disorder
- Patients with orthopedic and systemic disorders that prevent exercising
- Patients with active malignancies
- Diseases that affect the use of glasses (epilepsy, vision loss, etc.)
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Group 1 use virtual reality.
|
Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
|
|
Experimental: Group 2
Group 2 do traditional home exercises.
|
Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posturography
Time Frame: 1 year
|
Posturography; It gives numerical data by comparing the data obtained from these three systems, whichever is caused by the patient's balance disorder, somatosensory system affected, visual system affected, or vestibular system affected.
|
1 year
|
|
Subjective Visual Vertical
Time Frame: 1 year
|
Subjective visual vertical test, measures the functions of the utricular end organ.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fazıl N Ardıç, MD, Pamukkale 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 21, 2021
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
June 15, 2023
Study Registration Dates
First Submitted
February 21, 2021
First Submitted That Met QC Criteria
February 23, 2021
First Posted (Actual)
February 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 26, 2025
Last Update Submitted That Met QC Criteria
March 23, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 8
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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