Feasibility and Safety of an Immersive Virtual Reality-based Vestibular Rehabilitation Program for Dizziness, Balance and Fatigue Improvement in People With Multiple Sclerosis: Protocol for a Pilot Randomised Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Maria Jesus Casuso-Holgado
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Safety of virtual reality-based vestibular rehabilitation
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis.
The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.
Investigators
Maria Jesus Casuso-Holgado
Assistant Professor
University of Seville
Eligibility Criteria
Inclusion Criteria
- •Both male and female subjects from 18-65 years old
- •Clinically diagnosed with any type of multiple sclerosis in accordance with the revised McDonald criteria
- •With walking ability according to the Expanded Disability Status Scale score (EDSS =6)
- •With the objective presence of dizziness symptoms (Dizziness Handicap Inventory = 16)
Exclusion Criteria
- •Blurred vision
- •Cognitive impairment (Mini Mental State Examination =24)
- •Another neurologic disorder contributing to balance impairment
- •Relapse within the last 3 months
- •Changes in pharmacotherapy within the last 3 months
- •History of vestibular rehabilitation within the last 6 months
- •Acute cardiovascular of respiratory illness
- •Any other contraindication to physical activity
Outcomes
Primary Outcomes
Safety of virtual reality-based vestibular rehabilitation
Time Frame: 7 weeks of intervention
Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem Falls registry Adverse events registry
Feasibility of virtual reality-based vestibular rehabilitation
Time Frame: 7 weeks of intervention
Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability Participation rate Retention rate Adherence to treatment rate
Secondary Outcomes
- Change from baseline dizziness symptoms at 7 weeks(7 weeks after intervention)
- Change from baseline fatigue at 7 weeks(7 weeks after intervention)
- Change from baseline static balance at 7 weeks(7 weeks after intervention)
- Change from baseline quality of life at 7 weeks(7 weeks after intervention)