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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04497025
• Other study ID #: RVEM2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2026
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: University of Seville
• Contact: Maria Jesus Casuso-Holgado
• Phone: +34659213135
• Email: mcasuso[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Balance Disorders
• Cybersickness
• Dizziness
• Fatigue
• Multiple Sclerosis
• Quality of Life
• Sclerosis
• Usability
• Vertigo
• Vestibular Disease
• Vestibular Diseases

Intervention

Other:
• Immersive Virtual-based vestibular rehabilitation
Vestibular rehabilitation based on virtual environment using a head mounted display
• Conventional vestibular rehabilitation protocol
"Cawthorne-Cooksey" vestibular rehabilitation exercises.

Locations

Country	Name	City	State
Spain	Universidad de Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Maria Jesus Casuso-Holgado

Country where clinical trial is conducted

Spain, 

Outcome

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