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Completed

NCT Number: NCT03536533

Virtual Reality-based Dual-task Exercise in Vestibular Hypofunction Patients

The aim is to assess the effects of virtual reality-based intervention on vestibular functions in in patients with chronic peripheral unilateral vestibular hypofunction.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Zurich, Canton of Zurich, 8091, Switzerland

About this study

In a close interplay of sensory and motor functions, the brain constantly evaluates intrinsic and extrinsic movements, creating an inner - always subjective - representation of the stability. If there is an acute or chronic imbalance ("mismatch"), a multisensory misperception can occur. This is perceived subjectively as dizziness. Dizziness is the third most common neurological cause of an emergency with 11-13% after headache and stroke.

The central vestibular system is often involved in dizziness. The organ is part of the inner ear and is located in the petrous bone. It consist of macula organs, which are responsible for the detection of linear accelerations, and semicircular canals, which perceive the head velocity. Furthermore, the central vestibular system provides ocular muscles and the spinal cord with output, in order to control three reflexes. The vestibulo-ocular reflex (VOR) is responsible for a clear vision while the head is rotating, whereas the vestibulo-collic reflex (VCR) innervates the neck musculature in order to fix the head. The purpose of the vestibulo-spinal reflex (VSR) is the stabilization of the body by compensatory movements. In terms of restoring vestibular functioning, compensation can be classified into adaptation, substitution and habituation. Adaptation enhances the VOR, which is equivalent to restoration. Substitution is distinguished in literature between sensory and behavioral, in which the sensorial substitution transfers the importance given to proprioceptive and visual inputs and the behavioral substitution refers to avoidance strategies e.g. immobilization, increased blink reflex and prevention of head rotations. Habituation on the other hand, accustoms the affected person to a conflicting situation, in order that the response of the VOR is avoided.

So far, it is known that previous conventional vestibular rehabilitation is effective for age-related vestibular loss. By improving vestibular function, the vestibular rehabilitation therapy aims to improve balance and neuromuscular coordination, minimize falls and decrease the feeling of dizziness.

However, new advances in technology have been made which generate additional methods for an effective therapy; exercise and videogaming, in short, exergaming. Successful use of virtual reality in rehabilitation of vestibular patients has previously been implemented. Further, recent evidence has examined the effects of exergaming in healthy dwellers on vestibular function. There was a significant reduction found in the dynamic visual acuity (DVA) after an eight-session exergame training (in total 160 minutes).

To date, the effects on vestibulo-ocular reflex of exergames in patients with chronic peripheral vestibular hypofunction have not been systematically explored. Moreover, very little is known about the effects of exergaming includes exercises requiring head turns on vestibular function in this patients. Furthermore, exergaming could become a new tool to improve DVA and dizziness and increase the training intensity without requiring many therapists, which in turn reduces health costs. In addition, patients with dizziness are severely affected by their disease. They will welcome new, efficient and motivating forms of therapy.Finally, the main aim is to assess the effects of virtual reality-based intervention with dividat "senso" on vestibular functions in patients with chronic peripheral unilateral vestibular hypofunction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic peripheral unilateral vestibular hypofunction
  • Signed informed consent after being informed

Exclusion criteria

  • Patients with Benign paroxysmal positional vertigo and/or Menière's disease
  • Walking disability (independent walking <10 meters)
  • Acute pain and limited range of motion in cervical spine
  • Gait disorders putatively attributed to other than primarily vestibular causes
  • Weakness due to neurological problems
  • Uncontrolled cardiovascular disease
  • Medication reducing postural balance
  • Uncorrected heavy visual impairment
  • Acute pain

Treatment and study plan

Exergame

Other

Each of the 8 exercise sessions will last at least 42 minutes, with an actual training duration of 21 minutes. The participants will be accustomed gradually to the game. On one hand this will be achieved by increasing the difficulty in subsequent levels within the exergame.

Other names: SENSO Dividat

Primary outcomes

  1. Dynamic Visual Acuity (DVA)

    Time frame: 15 minutes

    The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity

Secondary outcomes

  1. Video Head Impulse Test (vHIT)

    Time frame: 15 minutes

    The vHIT will be used to test the vestibulo-ocular reflex.

  2. Suppression Head Impulse Paradigm (SHIMP)

    Time frame: 15 minutes

    In contrary to vHIT, which indicate a compensatory saccade and thus a vestibular loss, the suppression head impulse paradigm (SHIMP) measures the vestibular function

  3. Subjective Visual Vertical test (SVV)

    Time frame: 15 minutes

    SVV assesses the ability to perceive verticality which depends on input from visual, somatosensory and vestibular system

  4. Functional Gait Assessment (FGA)

    Time frame: 15 minutes

    The FGA is used to measure disturbances in balance and gait

  5. Extended Timed Get-Up-And-Go (ETGUG)

    Time frame: 15 minutes

    The time measured during each task and the overall time mirrors the functional mobility of the participant

  6. Simulator Sickness Questionnaire (SQQ)

    Time frame: 5 minutes

    The SSQ questionnaire assesses, cyber or virtual reality sickness

  7. Misery Score (MISC 1-6)

    Time frame: 1 minutes

    The Misery score is a scale to gather the nausea symptom

  8. Dizziness handicap inventory (DHI)

    Time frame: 10 minutes

    The DHI is questionnaire to evaluate the self-perceived handicapping effects caused by dizziness

  9. Game Scores

    Time frame: 1 minutes

    Game intervention administration and dosage (frequency, intensity, time and type of the video game

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Patients With Chronic Peripheral Unilateral Vestibular Hypofunction

Acronym: VR-VH-ex

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 24, 2018
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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