The Effect of Different Head and Trunk Positions on SVV in Healthy Individuals

The Effect of Different Head and Trunk Positions on Static Virtual SVV and Dynamic Virtual SVV in Healthy Individuals: A Standardization Study

Aim: To obtain standardization data in static virtual SVV and dynamic virtual SVV tests according to different head and body positions by keeping up with developing technologies. In this way, it is planned to evaluate the treatment responses of patients who receive vestibular rehabilitation in a healthier way.

Study Overview

• Status: Completed
• Conditions: Virtual Reality
• Intervention / Treatment: Diagnostic test: SVV test

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult volunteers
2. Volunteers over 18 years old

Exclusion Criteria:

1. Patients with impaired cooperation
2. Musculoskeletal or systemic presence of disease
3. Past ear disease
4. Patients who have experienced dizziness
5. Presence of central nervous system pathology
6. Patients who have used ototoxic drugs
7. Patients whose use of glasses may cause problems (epilepsy, vision loss, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; SVV test will be done.	Diagnostic test: SVV test; SVV test will be done with virtual reality glasses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static SVV test	For commercially available VR Subjective Visual vertical(SVV), VIRTUALIS® PHYSIO VR[SVV and Dynamic SVV](Virtualis, France) was used. The bar angles are given in a random order. The system consists of glasses, computer and hand control. When patients wear their glasses, they can see only a light bar in Static SVV, and points rotating left or right on the background of the light bar in Dynamic SVV. No light can enter the glasses. The glasses have a sensor that detects the angle of the head. The starting point of the bar can be adjusted randomly to different angles by the computer. The visual background rotation rate for dynamic SVV was determined as ±30°/sec. The subject should adjust the bar in the vertical position using the right/left arrows on the controller. When verticality is confirmed by pressing the set button in the middle of the control unit, the computer records the angle of the bar and the position of the head.	1 month
Dynamic SVV test	For commercially available VR Subjective Visual vertical(SVV), VIRTUALIS® PHYSIO VR[SVV and Dynamic SVV](Virtualis, France) was used. The bar angles are given in a random order. The system consists of glasses, computer and hand control. When patients wear their glasses, they can see only a light bar in Static SVV, and points rotating left or right on the background of the light bar in Dynamic SVV. No light can enter the glasses. The glasses have a sensor that detects the angle of the head. The starting point of the bar can be adjusted randomly to different angles by the computer. The visual background rotation rate for dynamic SVV was determined as ±30°/sec. The subject should adjust the bar in the vertical position using the right/left arrows on the controller. When verticality is confirmed by pressing the set button in the middle of the control unit, the computer records the angle of the bar and the position of the head.	1 month

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Fazıl Necdet Ardıç, Professor, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: September 26, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No