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

Physical Disability Clinical Trial

— DizzyVR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350721
• Other study ID #: DizzyVR
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: Universidad Loyola Andalucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to assess the safety and feasibility of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. 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.

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men or women between the ages of 18 and 65.

• Confirmed diagnosis of central or peripheral vestibulopathy.

• Preserved walking ability.

• Presence of mild to moderate dizziness as assessed by the Dizziness Handicap Inventory (= 60 points).

Exclusion Criteria:

• Severe visual impairments.

• Cognitive impairment (Mini Mental State Examination < 24) [34].

• Existence of comorbidities severely affecting postural control and balance.

• Uncontrolled systemic diseases that contradict physical activity.

Related Conditions & MeSH terms

• Physical Disability
• Vestibular Diseases
• Vestibular Disorder

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Loyola Andalucia	Universidad de Zaragoza, Universitat Politècnica de València, University of Seville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate of participants	Feasibility of the prototype device/software	10 weeks
Primary	User Satisfaction Evaluation Questionnaire (USEQ)	Acceptability of the prototype device/software	10 weeks
Primary	Register of risk and number of adverse events experimented by the stakeholders	Security of the prototype device	10 weeks
Primary	Adherence rate	percentage of completed sessions	10 weeks
Primary	Dropout rates	percentage of dropouts of participants	10 weeks