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

May 18, 2020 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Gait Assessment (FGA)
Time Frame: 15 minutes
The FGA is used to measure disturbances in balance and gait
15 minutes
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
15 minutes
Video Head Impulse Test (vHIT)
Time Frame: 15 minutes
The vHIT will be used to test the vestibulo-ocular reflex.
15 minutes
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
15 minutes
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
15 minutes
Simulator Sickness Questionnaire (SQQ)
Time Frame: 5 minutes
The SSQ questionnaire assesses, cyber or virtual reality sickness
5 minutes
Misery Score (MISC 1-6)
Time Frame: 1 minutes
The Misery score is a scale to gather the nausea symptom
1 minutes
Dizziness handicap inventory (DHI)
Time Frame: 10 minutes
The DHI is questionnaire to evaluate the self-perceived handicapping effects caused by dizziness
10 minutes
Game Scores
Time Frame: 1 minutes
Game intervention administration and dosage (frequency, intensity, time and type of the video game
1 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (ACTUAL)

May 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • BASEC 2018-00337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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