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

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis; Quality of Life; Vestibular Disease; Balance Disorders; Usability; Cybersickness; Dizziness; Fatigue

• Registration Number: NCT04497025
• Lead Sponsor: Maria Jesus Casuso-Holgado

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Study Start: 2026-01
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 fatigue at 7 weeks	7 weeks after intervention	Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue 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 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.

Trial Locations

Locations (1)

Universidad de Sevilla; 🇪🇸 Sevilla, Spain