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Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR

NCT06350721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-25

No results posted yet for this study

Summary

The main goals of this pilot study is to assess the feasibility, usability, satisfaction and safety of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. In addition, it aims to collect preliminary data about clinical effectiveness. The main questions it aims to answer are:

* To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.
* To detect and record possible adverse events due to the use of DizzyVR.
* To examine the degree of adherence of the participants to the intervention.
* To know the average success rate of the different games in each session.
* To evaluate the average difficulty levels overcome throughout the intervention.
* To know the usability and satisfaction with the system reported by participants and therapists.
* To assess preliminary efficacy data on the impact of this new vestibular rehabilitation system on dizziness, gait speed, balance confidence and gait stability.

Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR.

Conditions

  • Vestibular Disorder
  • Physical Disability

Interventions

DEVICE

DizzyVR

Each patient will receive a total of 8 sessions of vestibular rehabilitation with the DizzyVR system. Each session will last for 50 minutes, with a frequency of one session per week. The total duration of the intervention will be 10 weeks, with the initial assessment/T0 taking place in the first week and the final assessment/T2 in the tenth week. Similarly, the total expected participation time for each participant is set at 12 weeks (T3).

Sponsors & Collaborators

  • University of Seville

    collaborator OTHER

  • Universitat Politècnica de València

    collaborator OTHER

  • Universidad de Zaragoza

    collaborator OTHER

  • Universidad Loyola Andalucia

    lead OTHER

Principal Investigators

  • MARIA JESÚS CASUSO-HOLGADO, PhD · University of Seville

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06350721 on ClinicalTrials.gov