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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immersive virtual reality-based vestibular training.

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.

Group Type EXPERIMENTAL

Immersive Virtual-based vestibular rehabilitation

Intervention Type OTHER

Vestibular rehabilitation based on virtual environment using a head mounted display

Conventional vestibular training.

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).

Group Type ACTIVE_COMPARATOR

Conventional vestibular rehabilitation protocol

Intervention Type OTHER

"Cawthorne-Cooksey" vestibular rehabilitation exercises.

Interventions

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Immersive Virtual-based vestibular rehabilitation

Vestibular rehabilitation based on virtual environment using a head mounted display

Intervention Type OTHER

Conventional vestibular rehabilitation protocol

"Cawthorne-Cooksey" vestibular rehabilitation exercises.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No