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Virtual Reality-based Dual-task Exercise in Vestibular Hypofunction Patients (VR-VH-ex)

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ClinicalTrials.gov Identifier: NCT03536533
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Vestibular Diseases Other: Exergame Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Patients With Chronic Peripheral Unilateral Vestibular Hypofunction
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 23, 2018
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exergame
The 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.
Other: Exergame
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 Name: SENSO Dividat




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536533


Contacts
Contact: Jaap Swanenburg, PhD +41 44 255 3664 jaap.swanenburg@usz.ch

Locations
Switzerland
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Jaap Swanenburg, PhD    +41 44 255 3664    jaap.swanenburg@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Jaap Swanenburg, PhD University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03536533     History of Changes
Other Study ID Numbers: BASEC 2018-00337
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases