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

Primary Purpose

Vestibular Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exergame
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exergame

Arm Description

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.

Outcomes

Primary Outcome Measures

Dynamic Visual Acuity (DVA)
The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2018
Last Updated
May 18, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03536533
Brief Title
Virtual Reality-based Dual-task Exercise in Vestibular Hypofunction Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Swanenburg, PhD
Organizational Affiliation
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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