Back to resultsConventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Vestibular Disease, Dizziness
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Immersive Virtual-based vestibular rehabilitation
Conventional vestibular rehabilitation protocol
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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
Sites / Locations
- Universidad de Sevilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immersive virtual reality-based vestibular training.
Conventional vestibular training.
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change from baseline dizziness symptoms at 7 weeks
Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.
Change from baseline static balance at 7 weeks
Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.
Change from baseline fatigue at 7 weeks
Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04497025
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Jesus Casuso-Holgado
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Vestibular Disease, Dizziness, Balance Disorders, Fatigue, Quality of Life, Usability, Cybersickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immersive virtual reality-based vestibular training.
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional vestibular training.
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Immersive Virtual-based vestibular rehabilitation
Intervention Description
Vestibular rehabilitation based on virtual environment using a head mounted display
Intervention Type
Other
Intervention Name(s)
Conventional vestibular rehabilitation protocol
Intervention Description
"Cawthorne-Cooksey" vestibular rehabilitation exercises.
Primary Outcome Measure Information:
Title
Feasibility of virtual reality-based vestibular rehabilitation
Description
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
Title
Safety of virtual reality-based vestibular rehabilitation
Description
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 Outcome Measure Information:
Title
Change from baseline dizziness symptoms at 7 weeks
Description
Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.
Time Frame
7 weeks after intervention
Title
Change from baseline static balance at 7 weeks
Description
Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.
Time Frame
7 weeks after intervention
Title
Change from baseline fatigue at 7 weeks
Description
Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.
Time Frame
7 weeks after intervention
Title
Change from baseline quality of life at 7 weeks
Description
Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life.
Time Frame
7 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Jesus Casuso-Holgado
Phone
+34659213135
Email
mcasuso@us.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Casuso-Holgado
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Sevilla
City
Sevilla
ZIP/Postal Code
41004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Casuso-Holgado
Phone
+34659213135
Email
mcasuso@us.es
First Name & Middle Initial & Last Name & Degree
Maria Jesus Casuso-Holgado
First Name & Middle Initial & Last Name & Degree
Cristina Garcia-Muñoz
First Name & Middle Initial & Last Name & Degree
Maria Dolores Cortes-Vega
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34810187
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.
Results Reference
derived
Learn more about this trial
Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis
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