NCT04769323

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

February 21, 2021

Last Update Submit

March 23, 2025

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (2)

  • Posturography

    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

    Subjective visual vertical test, measures the functions of the utricular end organ.

    1 year

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 use virtual reality.

Device: Virtual Reality

Group 2

EXPERIMENTAL

Group 2 do traditional home exercises.

Other: Traditional home exercises

Interventions

Virtual RealityDEVICE

Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.

Group 1
Traditional home exercisesOTHER

Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.

Group 2

Eligibility Criteria

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

You may qualify if:

  • Complaining dizziness and/or instability for more than 3 months
  • Patients aged 18 and over and under 65

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Denizli, 20070, Turkey (Türkiye)

Location

Study Officials

  • Fazıl N Ardıç, MD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

February 21, 2021

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)