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

WithdrawnNot a drug-phase studyMS (type not specified)NCT04497025

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Lack of funding.

What was tested

Treatment tested

  • Immersive Virtual-based vestibular rehabilitation

Compared with

  • Conventional vestibular rehabilitation protocol

What it measured

Main measures

  • Feasibility of virtual reality-based vestibular rehabilitation

    7 weeks of intervention

    Quality of life (reported by participants)Feasibility
  • Safety of virtual reality-based vestibular rehabilitation

    7 weeks of intervention

    Walking and mobilitySafety

Other measures (4)

  • Change from baseline dizziness symptoms at 7 weeks

    7 weeks after intervention

  • Change from baseline static balance at 7 weeks

    7 weeks after intervention

    Walking and mobility
  • Change from baseline fatigue at 7 weeks

    7 weeks after intervention

    Fatigue
  • Change from baseline quality of life at 7 weeks

    7 weeks after intervention

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jan 2026

    2. Main results due

      Dec 2028

    3. Finished

      Dec 2029

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