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

NCT ID: NCT06350721

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Intervention group

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).

Group Type: EXPERIMENTAL

DizzyVR

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men or women between the ages of 18 and 75.
• Confirmed diagnosis of central or peripheral vestibulopathy.
• Preserved walking ability.
• Presence of dizziness symptoms as assessed by the Dizziness Handicap Inventory (> 10 points).

Exclusion Criteria

• Severe visual impairments.
• Cognitive impairment (Mini Mental State Examination < 24).
• Existence of comorbidities severely affecting postural control and balance.
• Uncontrolled systemic diseases that contradict physical activity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: collaborator

Universitat Politècnica de València

OTHER

Sponsor Role: collaborator

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Universidad Loyola Andalucia

OTHER

Sponsor Role: lead

Responsible Party

Cristina García-Muñoz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARIA JESÚS CASUSO-HOLGADO, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Universidad de Sevilla

Seville, , Spain

Countries

Spain

Other Identifiers

DizzyVR

Identifier Type: -

Identifier Source: org_study_id