Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR
DizzyVR
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedSeptember 25, 2025
September 1, 2025
4 months
January 17, 2024
September 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Secondary Outcomes (4)
Dizziness Handicap Inventory
10 weeks
Timed Up and Go Test (TUG)
10 weeks
Activities-specific Balance Confidence Scale (ABC)
10 weeks
Functional Gait Assessment questionnaire (FGA)
10 weeks
Study Arms (1)
Intervention group
EXPERIMENTALEach 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
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).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Loyola Andalucialead
- University of Sevillecollaborator
- Universitat Politècnica de Valènciacollaborator
- Universidad de Zaragozacollaborator
Study Sites (1)
Universidad de Sevilla
Seville, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MARIA JESÚS CASUSO-HOLGADO, PhD
University of Seville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 17, 2024
First Posted
April 5, 2024
Study Start
October 1, 2024
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
September 25, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Data of study will be only manage by the researchers of study and the physiotherapist of the clinic