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

N/ANot Yet RecruitingNCT04497025

Maria Jesus Casuso-Holgado30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis Vestibular Disease Dizziness Balance Disorders

Interventions

Immersive Virtual-based vestibular rehabilitationOTHER

Vestibular rehabilitation based on virtual environment using a head mounted display

Conventional vestibular rehabilitation protocolOTHER

"Cawthorne-Cooksey" vestibular rehabilitation exercises.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 7 weeks of intervention

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

Time frame: 7 weeks of intervention

Secondary Outcomes

Change from baseline dizziness symptoms at 7 weeks

Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.

Time frame: 7 weeks after intervention

Change from baseline static balance at 7 weeks

Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.

Time frame: 7 weeks after intervention

Change from baseline fatigue at 7 weeks

Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.

Time frame: 7 weeks after intervention

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.

Time frame: 7 weeks after intervention

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts