Use of Virtual Reality Devices for Vestibular Rehabilitation

Sponsor

Pamukkale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04769323

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality	Device: Virtual Reality Other: Traditional home exercises	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Use of Virtual Reality Devices for Vestibular Rehabilitation in Patients With Vestibular Hypofunction

Actual Study Start Date :

Jun 15, 2020

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group 1 use virtual reality.	Device: 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.	Other: 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.
Experimental: Group 3 Group 3 do traditional home exercises and virtual reality.	Device: 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. Other: 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.

Arm

Intervention/Treatment

Experimental: Group 1

Group 1 use virtual reality.

Device: 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.

Other: 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.

Experimental: Group 3

Group 3 do traditional home exercises and virtual reality.

Device: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Posturography [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.
Subjective Visual Vertical [1 year]
Subjective visual vertical test, measures the functions of the utricular end organ.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Complaining dizziness and/or instability for more than 3 months
Patients aged 40 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli		Turkey	20070

Sponsors and Collaborators

Pamukkale University

Investigators

Principal Investigator: Fazıl N Ardıç, MD, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fazıl Necdet Ardıç, Professor, Pamukkale University

ClinicalTrials.gov Identifier:

NCT04769323

Other Study ID Numbers:

First Posted:

Feb 24, 2021

Last Update Posted:

Jan 4, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jan 4, 2022