Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-01-17
Brief Title:
Feasibility Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR
Sponsor:
Universidad Loyola Andalucia
Organization:
Universidad Loyola Andalucia
Study Overview
Official Title:
Feasibility Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DizzyVR
Brief 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
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
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 assessmentT0 taking place in the first week and the final assessmentT2 in the tenth week Similarly the total expected participation time for each participant is set at 12 weeks T3
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 assessmentT0 taking place in the first week and the final assessmentT2 in the tenth week Similarly the total expected participation time for each participant is set at 12 weeks T3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None