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| Name | Class |
|---|---|
| University of Seville | OTHER |
| Universitat Politècnica de València | OTHER |
| Universidad de Zaragoza | OTHER |
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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:
Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate | percentage of completed sessions | 10 weeks |
| Success rate | Mean success rates of the games per session | 10 weeks |
| Progression | Levels of the games accomplished during the sessions. | 10 weeks |
| System Usability Scale (SUS) | Participants perceived usability of the system. | 10 weeks |
| User Satisfaction Evaluation Questionnaire (USEQ) | Acceptability of the prototype device/software | 10 weeks |
| Simulator Sickness Questionnaire (SSQ) | Security of the system | 10 weeks |
| Register of risk and number of adverse events experimented by the stakeholders | Security of the prototype device | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory | Dizziness symptoms | 10 weeks |
| Timed Up and Go Test (TUG) | Gait speed | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARIA JESÚS CASUSO-HOLGADO, PhD | University of Seville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Sevilla | Seville | Spain |
Data of study will be only manage by the researchers of study and the physiotherapist of the clinic
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Activities-specific Balance Confidence Scale (ABC) | Perceived balance confidence | 10 weeks |
| Functional Gait Assessment questionnaire (FGA) | Gait stability | 10 weeks |