- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497025
Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis
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
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Jesus Casuso-Holgado
- Phone Number: +34659213135
- Email: mcasuso@us.es
Study Locations
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-
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Sevilla, Spain, 41004
- Universidad de Sevilla
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Contact:
- Maria Jesus Casuso-Holgado
- Phone Number: +34659213135
- Email: mcasuso@us.es
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Principal Investigator:
- Maria Jesus Casuso-Holgado
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Principal Investigator:
- Cristina Garcia-Muñoz
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Principal Investigator:
- Maria Dolores Cortes-Vega
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline dizziness symptoms at 7 weeks
Time Frame: 7 weeks after intervention
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Dizziness Handicap Inventory (0-100 points).
Higher scores mean worse dizziness symptoms.
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7 weeks after intervention
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Change from baseline static balance at 7 weeks
Time Frame: 7 weeks after intervention
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Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale.
Higher score better balance.
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7 weeks after intervention
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Change from baseline fatigue at 7 weeks
Time Frame: 7 weeks after intervention
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Modified Fatigue Impact Scale (0-84 points).
Higher scores mean worse fatigue symptoms.
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7 weeks after intervention
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Change from baseline quality of life at 7 weeks
Time Frame: 7 weeks after intervention
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Multiple Sclerosis Quality of Life Scale 54 (0-100 points).
Higher values indicate better quality of life.
|
7 weeks after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Jesus Casuso-Holgado, University of Seville
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Sensation Disorders
- Multiple Sclerosis
- Sclerosis
- Fatigue
- Vertigo
- Dizziness
- Vestibular Diseases
Other Study ID Numbers
- RVEM2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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