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

Vestibular Diseases Clinical Trial

— VR-VH-ex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536533
• Other study ID #: BASEC 2018-00337
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Visual Acuity (DVA)	The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity	15 minutes
Secondary	Video Head Impulse Test (vHIT)	The vHIT will be used to test the vestibulo-ocular reflex.	15 minutes
Secondary	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	15 minutes
Secondary	Subjective Visual Vertical test (SVV)	SVV assesses the ability to perceive verticality which depends on input from visual, somatosensory and vestibular system	15 minutes
Secondary	Functional Gait Assessment (FGA)	The FGA is used to measure disturbances in balance and gait	15 minutes
Secondary	Extended Timed Get-Up-And-Go (ETGUG)	The time measured during each task and the overall time mirrors the functional mobility of the participant	15 minutes
Secondary	Simulator Sickness Questionnaire (SQQ)	The SSQ questionnaire assesses, cyber or virtual reality sickness	5 minutes
Secondary	Misery Score (MISC 1-6)	The Misery score is a scale to gather the nausea symptom	1 minutes
Secondary	Dizziness handicap inventory (DHI)	The DHI is questionnaire to evaluate the self-perceived handicapping effects caused by dizziness	10 minutes
Secondary	Game Scores	Game intervention administration and dosage (frequency, intensity, time and type of the video game	1 minutes