Clinical trial NCT04497025: Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Vestibular Disease
Dizziness
Balance Disorders
Fatigue
Quality of Life
Usability
Cybersickness
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of virtual reality-based vestibular rehabilitation
timeFrame: 7 weeks of intervention
measure: Safety of virtual reality-based vestibular rehabilitation
timeFrame: 7 weeks of intervention
Secondary outcomes:
measure: Change from baseline dizziness symptoms at 7 weeks
timeFrame: 7 weeks after intervention
measure: Change from baseline static balance at 7 weeks
timeFrame: 7 weeks after intervention
measure: Change from baseline fatigue at 7 weeks
timeFrame: 7 weeks after intervention
measure: Change from baseline quality of life at 7 weeks
timeFrame: 7 weeks after intervention
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
affiliation: University of Seville
name: Maria Jesus Casuso-Holgado
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Munoz C, Casuso-Holgado MJ, Hernandez-Rodriguez JC, Pinero-Pinto E, Palomo-Carrion R, Cortes-Vega MD. Feasibility and safety of an immersive virtual reality-based vestibular rehabilitation programme in people with multiple sclerosis experiencing vestibular impairment: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Nov 22;11(11):e051478. doi: 10.1136/bmjopen-2021-051478.