- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160352
Effects of Exergames on Vestibular Function in Healthy Community Dwellers.
May 18, 2020 updated by: University of Zurich
Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Healthy Community Dwellers. A Pilot Study
The aim is to assess the effects of virtual reality-based intervention on vestibular functions in healthy community dwellers.
Study Overview
Detailed Description
Elderly usually experience an age-related type of vestibular disorder, which involves vertigo, dizziness and poor postural stability.
These symptoms seem to contribute to the "geriatric syndrome", which describes a complex symptomatology.
It usually has multiple causes and must be considered interdisciplinary.
This study will only consider healthy elderly with an expected age-related degeneration of the vestibular system.
In terms of restoring vestibular functioning, compensation can be classified into adaptation, substitution and habituation.
Adaptation enhances the Vestibulo-ocular reflex, which is equivalent to restoration.
Habituation on the other hand, accustoms the affected person to a conflicting situation, in order that the response of the Vestibulo-ocular reflex is avoided.
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.
Slower gait speed may also be a method used by elderly for compensation during a task when the base of support is unstable.
Considering recommendation future studies should incorporate examinations of functional gaze stability during typical daily tasks in more familiar settings as opposed to laboratory assessments.
Increased head movement may disturb balance and the risk of falling may be raised while walking stairs.
As head stability is challenged during stair descent, elderly with age-related visual and vestibular impairment have problems with completing this quotidian task.
A way to consider these observations in vestibular rehabilitation is the use of a virtual reality environment, which provides a motivating and pleasant method to train and that includes exercises requiring head turns.
Successful use of virtual reality in rehabilitation of vestibular patients has previously been implemented.
However, these studies did not particularly to exercise head turns by completing an orientation task.
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
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ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy community dwellers Adult male and female participant's (≥65 years) Signed informed consent after being informed
Exclusion Criteria:
Benign paroxysmal positional vertigo Acute pain Walking disability (independent walking <10 meters) Uncontrolled cardiovascular disease (e.g.: uncontrolled blood pressure) Weakness due to neurological problems
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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In total, 10 sessions were accomplished including baseline and post intervention measurements.
The remaining eight exercise sessions lasted 40 minutes, with an actual training duration of 20 minutes.
This resulted in a cumulative total intervention exercise time of 160 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Visual Acuity (DVA)
Time Frame: 30 minutes
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The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Gait Assessment (FGA)
Time Frame: 15 minutes
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The FGA is used to measure disturbances in balance and gait
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15 minutes
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Extended Timed Get-Up-And-Go (ETGUG)
Time Frame: 15 minutes
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The time measured during each task and the overall time mirrors the functional mobility of the participant
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15 minutes
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Gait speed
Time Frame: 5 minutes
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Time was measured in with a stopwatch as the participants walked in the central 6 m of the walkway.
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5 minutes
|
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Simulator Sickness Questionnaire (SSQ)
Time Frame: 5 minutes
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The SSQ questionnaire assesses, cyber or virtual reality sickness
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5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Swanenburg Jaap, PhD, University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
May 12, 2017
Primary Completion (Actual)
June 25, 2017
Study Completion (Actual)
July 10, 2017
Study Registration Dates
First Submitted
May 17, 2017
First Submitted That Met QC Criteria
May 17, 2017
First Posted (Actual)
May 19, 2017
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC 2016-1220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Publication
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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