NCT06350721

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Universidad Loyola Andalucia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Once the patient is received in the physiotherapy area of the Vertigo Unit, the researchers will proceed to provide the informational sheet and informed consent, as well as verbally explain the project. After the informed consent is signed, the researchers will collect all descriptive variables, as well as the baseline score of the DHI questionnaire (T0). During the course of the research, the researchers will daily record participants' attendance, the overall percentage of correct answers in each session, the occurrence of undesired effects, and the score of the Simulator Sickness Questionnaire (T1). In the final physiotherapy session (T2), each participant will re-evaluate the DHI questionnaire, as well as the perceived usability questionnaire of the system (SUS) and the virtual systems satisfaction evaluation questionnaire (USEQ). Finally, approximately 15 days after the intervention concludes, participants will be scheduled for in-depth individual perceptions about the system through a semi-structured interview (T3). With the same purpose, after the period of using the DizzyVR system, the researchers will interview the physiotherapists who have participated in this study (T4). 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).

Conditions

• Vestibular Disorder
• Physical Disability

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-04-05
• Last updated: 2025-09-25

Locations

1 site across 1 country: Spain