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

NCT04497025 | Withdrawn

• 1 other identifier: RVEM2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Change from baseline dizziness symptoms at 7 weeks

  7 weeks after intervention

• Change from baseline static balance at 7 weeks

  7 weeks after intervention

• Change from baseline fatigue at 7 weeks

  7 weeks after intervention

• Change from baseline quality of life at 7 weeks

  7 weeks after intervention

Study Arms (2)

Immersive virtual reality-based vestibular training.

EXPERIMENTAL

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.

Other: Immersive Virtual-based vestibular rehabilitation

Conventional vestibular training.

ACTIVE COMPARATOR

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).

Other: Conventional vestibular rehabilitation protocol

Interventions

Immersive Virtual-based vestibular rehabilitation OTHER

Vestibular rehabilitation based on virtual environment using a head mounted display

Immersive virtual reality-based vestibular training.

Conventional vestibular rehabilitation protocol OTHER

"Cawthorne-Cooksey" vestibular rehabilitation exercises.

Conventional vestibular training.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Jesus Casuso-Holgado: lead

Study Sites (1)

Universidad de Sevilla

Seville, Sevilla, 41004, Spain

Location

Related Publications (1)

• 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.

  PMID: 34810187 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Vestibular Diseases; Dizziness; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Jesus Casuso-Holgado

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: August 4, 2020
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

ES (1)