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NCT04497025 | NOT YET RECRUITING | Multiple Sclerosis

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

Maria Jesus Casuso-Holgado

Information provided by (Responsible Party):

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.

Condition or disease

Multiple Sclerosis

Vestibular Disease

Dizziness

Balance Disorders

Fatigue

Quality of Life

Usability

Cybersickness

Intervention/treatment

Immersive Virtual-based vestibular rehabilitation

Conventional vestibular rehabilitation protocol

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : SINGLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-01
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis

Location Details

NCT04497025

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How to Participate

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Locations

Not yet recruiting

Spain,

University of Seville

Sevilla, Spain, 41004