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

May 15, 2023 updated by: Maria Jesus Casuso-Holgado

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

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 Overview

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria Jesus Casuso-Holgado
  • Phone Number: +34659213135
  • Email: mcasuso@us.es

Study Locations

      • Sevilla, Spain, 41004
        • Universidad de Sevilla
        • Contact:
          • Maria Jesus Casuso-Holgado
          • Phone Number: +34659213135
          • Email: mcasuso@us.es
        • Principal Investigator:
          • Maria Jesus Casuso-Holgado
        • Principal Investigator:
          • Cristina Garcia-Muñoz
        • Principal Investigator:
          • Maria Dolores Cortes-Vega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

Vestibular rehabilitation based on virtual environment using a head mounted display
Active Comparator: 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).

"Cawthorne-Cooksey" vestibular rehabilitation exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of virtual reality-based vestibular rehabilitation
Time Frame: 7 weeks of intervention

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
Time Frame: 7 weeks of intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline dizziness symptoms at 7 weeks
Time Frame: 7 weeks after intervention
Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.
7 weeks after intervention
Change from baseline static balance at 7 weeks
Time Frame: 7 weeks after intervention
Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.
7 weeks after intervention
Change from baseline fatigue at 7 weeks
Time Frame: 7 weeks after intervention
Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.
7 weeks after intervention
Change from baseline quality of life at 7 weeks
Time Frame: 7 weeks after intervention
Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life.
7 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria Jesus Casuso-Holgado, University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2024

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

July 18, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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