Balance Disorders, Cybersickness, Dizziness, Fatigue, Multiple Sclerosis, Quality of Life, Usability, Vestibular Disease
Conditions
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.
Interventions
OTHERImmersive Virtual-based vestibular rehabilitation
Vestibular rehabilitation based on virtual environment using a head mounted display
OTHERConventional vestibular rehabilitation protocol
"Cawthorne-Cooksey" vestibular rehabilitation exercises.
Sponsors
Maria Jesus Casuso-Holgado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of virtual reality-based vestibular rehabilitation | 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 |
| Safety of virtual reality-based vestibular rehabilitation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline dizziness symptoms at 7 weeks | 7 weeks after intervention | Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms. |
| Change from baseline static balance at 7 weeks | 7 weeks after intervention | Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance. |
| Change from baseline fatigue at 7 weeks | 7 weeks after intervention | Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms. |
| Change from baseline quality of life at 7 weeks | 7 weeks after intervention | Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMaria Jesus Casuso-Holgado
University of Seville
Outcome results
None listed