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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04497025
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Maria Jesus Casuso-Holgado
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Maria Jesus Casuso-Holgado
Principal Investigator Affiliation University of Seville
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Vestibular Disease, Dizziness, Balance Disorders, Fatigue, Quality of Life, Usability, Cybersickness
Arms & Interventions

Arms

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.

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).

Interventions

Other: - Immersive Virtual-based vestibular rehabilitation

Vestibular rehabilitation based on virtual environment using a head mounted display

Other: - Conventional vestibular rehabilitation protocol

"Cawthorne-Cooksey" vestibular rehabilitation exercises.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Universidad de Sevilla, Sevilla, Spain

Status

Address

Universidad de Sevilla

Sevilla, , 41004

Site Contact

Maria Jesus Casuso-Holgado

[email protected]

+34659213135

Nearest Location

Site Contact

Maria Jesus Casuso-Holgado

[email protected]

+34659213135


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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