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Completed

NCT Number: NCT06350721

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Sevilla

Seville, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DizzyVR

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).

Primary outcomes

  1. Adherence rate

    Time frame: 10 weeks

    percentage of completed sessions

  2. Success rate

    Time frame: 10 weeks

    Mean success rates of the games per session

  3. Progression

    Time frame: 10 weeks

    Levels of the games accomplished during the sessions.

  4. System Usability Scale (SUS)

    Time frame: 10 weeks

    Participants perceived usability of the system.

  5. User Satisfaction Evaluation Questionnaire (USEQ)

    Time frame: 10 weeks

    Acceptability of the prototype device/software

  6. Simulator Sickness Questionnaire (SSQ)

    Time frame: 10 weeks

    Security of the system

  7. Register of risk and number of adverse events experimented by the stakeholders

    Time frame: 10 weeks

    Security of the prototype device

Secondary outcomes

  1. Dizziness Handicap Inventory

    Time frame: 10 weeks

    Dizziness symptoms

  2. Timed Up and Go Test (TUG)

    Time frame: 10 weeks

    Gait speed

  3. Activities-specific Balance Confidence Scale (ABC)

    Time frame: 10 weeks

    Perceived balance confidence

  4. Functional Gait Assessment questionnaire (FGA)

    Time frame: 10 weeks

    Gait stability

Sponsors and collaborators

Lead sponsor

Universidad Loyola Andalucia

Other

Collaborators

  • Universidad de Zaragoza
  • Universitat Politècnica de València
  • University of Seville

Registry information

Acronym: DizzyVR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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