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

Maria Jesus Casuso-Holgado

Status: Not yet enrolling

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

Treatments: Other: Conventional vestibular rehabilitation protocol; Other: Immersive Virtual-based vestibular rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04497025

RVEM2020

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Immersive virtual reality-based vestibular training.

Experimental group

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.

Treatment:

Other: Immersive Virtual-based vestibular rehabilitation

Conventional vestibular training.

Active Comparator group

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).

Treatment:

Other: Conventional vestibular rehabilitation protocol