Multiple Sclerosis Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2029 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Sevilla | Sevilla |
Lead Sponsor | Collaborator |
---|---|
Maria Jesus Casuso-Holgado |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change from baseline dizziness symptoms at 7 weeks | Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms. | 7 weeks after intervention | |
Secondary | 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 | |
Secondary | Change from baseline fatigue at 7 weeks | Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms. | 7 weeks after intervention | |
Secondary | 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 |
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