Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dizziness, Multiple Sclerosis, Vestibular Disease, Balance Disorders, Fatigue, Quality of Life, Usability, Cybersickness

Intervention / Treatment
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* Other: Immersive Virtual-based vestibular rehabilitation
* Other: Conventional vestibular rehabilitation protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immersive virtual reality-based vestibular training.<br>Subjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system. Participants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk. Same location, tailoring parameters and physical therapist supervision than conventional vestibular training. | Other: Immersive Virtual-based vestibular rehabilitation<br>* Vestibular rehabilitation based on virtual environment using a head mounted display<br>|
| Active Comparator: Conventional vestibular training.<br>Subjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional Cawthorne-Cooksey vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention. A physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain). | Other: Conventional vestibular rehabilitation protocol<br>* Cawthorne-Cooksey vestibular rehabilitation exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of virtual reality-based vestibular rehabilitation | Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability Participation rate Retention rate Adherence to treatment rate | 7 weeks of intervention | 
| Safety of virtual reality-based vestibular rehabilitation | Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem Falls registry Adverse events registry | 7 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline dizziness symptoms at 7 weeks | Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms. | 7 weeks after intervention | 
| Change from baseline static balance at 7 weeks | Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance. | 7 weeks after intervention | 
| Change from baseline fatigue at 7 weeks | Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms. | 7 weeks after intervention | 
| Change from baseline quality of life at 7 weeks | Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life. | 7 weeks after intervention |