Clinical trial NCT03536533: Virtual Reality-based Dual-task Exercise in Vestibular Hypofunction Patients
Official title: Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Patients With Chronic Peripheral Unilateral Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Dynamic Visual Acuity (DVA)
timeFrame: 15 minutes
Secondary outcomes:
measure: Video Head Impulse Test (vHIT)
timeFrame: 15 minutes
measure: Suppression Head Impulse Paradigm (SHIMP)
timeFrame: 15 minutes
measure: Subjective Visual Vertical test (SVV)
timeFrame: 15 minutes
measure: Functional Gait Assessment (FGA)
timeFrame: 15 minutes
measure: Extended Timed Get-Up-And-Go (ETGUG)
timeFrame: 15 minutes
measure: Simulator Sickness Questionnaire (SQQ)
timeFrame: 5 minutes
measure: Misery Score (MISC 1-6)
timeFrame: 1 minutes
measure: Dizziness handicap inventory (DHI)
timeFrame: 10 minutes
measure: Game Scores
timeFrame: 1 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
state: ZH
Study officials:
affiliation: University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References: