NCT05069701

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

September 26, 2021

Last Update Submit

January 1, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

SVV test will be done.

Diagnostic Test: SVV test

Interventions

SVV testDIAGNOSTIC_TEST

SVV test will be done with virtual reality glasses.

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult volunteers
  • Volunteers over 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

Study Officials

  • Fazıl Necdet Ardıç, Professor

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 6, 2021

Study Start

July 10, 2021

Primary Completion

October 10, 2022

Study Completion

December 10, 2022

Last Updated

January 4, 2023

Record last verified: 2022-01

Locations