- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536533
Virtual Reality-based Dual-task Exercise in Vestibular Hypofunction Patients (VR-VH-ex)
Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Patients With Chronic Peripheral Unilateral Vestibular Hypofunction
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC 2018-00337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Vestibular Diseases
-
Istanbul Medipol University HospitalCompletedVestibular Disease | Vestibular RehabilitationTurkey
-
Assistance Publique Hopitaux De MarseilleUnknownVestibular DisordersFrance
-
Cairo UniversityRecruitingPeripheral Vestibular DisordersEgypt
-
University of ZurichCompletedVestibular Perception | Damaged Vestibular SystemSwitzerland
-
University Hospital, Strasbourg, FranceRecruiting
-
United States Naval Medical Center, San DiegoThe Geneva FoundationWithdrawnHearing and Vestibular DisordersUnited States
-
University of ManitobaCompletedVestibular Neuronitis | Peripheral Vestibular Disorders | Vestibular Syndromes &/or Disorders (Labyrinthine)Canada
-
Hospital de Rehabilitacion Manuel RoccaActive, not recruitingVestibular Disease | Peripheral Vestibular DisorderArgentina
-
University of the Basque Country (UPV/EHU)BioarabaRecruitingVestibular Disease | Vestibular Disorder | Vestibular VertigoSpain
-
Massachusetts Eye and Ear InfirmaryOhio State University; University of Geneva, SwitzerlandCompletedVestibular Disorder | Vestibular Ataxia | Vestibular Loss, BilateralUnited States, Switzerland
Clinical Trials on Exergame
-
University of LeicesterUniversity of Nottingham; University of Plymouth; University of Exeter; European...Recruiting
-
University of MinnesotaCompletedPreclinical Alzheimer's DiseaseUnited States
-
University of ZurichCompletedVestibular DiseasesSwitzerland
-
Baylor College of MedicineBioSensicsRecruitingCognitive Impairment | Dementia | Mild Cognitive Impairment | Memory LossUnited States
-
MaineHealthRobert Wood Johnson FoundationCompleted
-
Eling DeBruinRecruitingMultiple SclerosisSwitzerland
-
Swiss Federal Institute of TechnologyCompletedEffects of Exergaming on Cognitive Functions in Young AthletenSwitzerland
-
Eling DeBruinCompletedMild Neurocognitive DisorderSwitzerland
-
National Yang Ming UniversityUnknown
-
Université de MontréalCompleted