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Vestibular DiseasesVR-VH-exNCT03536533

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

A study testing Exergame in people with Vestibular Diseases, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Vestibular Diseases
What is being tested?
Exergame
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSwitzerland
Study dates
1 Aug 2018to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Medication reducing postural balance
  • Uncorrected heavy visual impairment
  • Acute pain

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

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

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

Read the detailed description

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.

Being tested
Exergame
Medical subject headings
Vestibular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExergameOther

    Also called SENSO Dividat

    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.

Study groups in NCT03536533
Study groupRoleWhat they receive
ExergameExperimentalThe Senso is a training system (dividat, Schindellegi, Switzerland) for improving physical and cognitive function was used as exergame. With foot pushes participants triggered on a pressure-sensitive plate. The Senso game was projected with a beamer at white wall. To promote head movement during training the direction of the beamer was vertical tilted (± 15°) and horizontal turned (90°) with a remote controlled power panner.
Receives: Other: Exergame

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dynamic Visual Acuity (DVA)

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

    Measured: 15 minutes

Secondary outcomes (9)
  1. Video Head Impulse Test (vHIT)

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

    Measured: 15 minutes

  2. Suppression Head Impulse Paradigm (SHIMP)

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

    Measured: 15 minutes

  3. Subjective Visual Vertical test (SVV)

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

    Measured: 15 minutes

  4. Functional Gait Assessment (FGA)

    The FGA is used to measure disturbances in balance and gait

    Measured: 15 minutes

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

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

    Measured: 15 minutes

  6. Simulator Sickness Questionnaire (SQQ)

    The SSQ questionnaire assesses, cyber or virtual reality sickness

    Measured: 5 minutes

  7. Misery Score (MISC 1-6)

    The Misery score is a scale to gather the nausea symptom

    Measured: 1 minutes

  8. Dizziness handicap inventory (DHI)

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

    Measured: 10 minutes

  9. Game Scores

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

    Measured: 1 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start1 Aug 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03536533
Sponsor's protocol ID
BASEC 2018-00337
Acronym
VR-VH-ex
Status last verified
May 2020
First submitted
14 May 2018
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exergame in people with Vestibular Diseases, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamic Visual Acuity (DVA) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.

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