Vestibular DiseasesNCT03160352
Effects of Exergames on Vestibular Function in Healthy Community Dwellers.
A study testing Exergame in people with Vestibular Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim is to assess the effects of virtual reality-based intervention on vestibular functions in healthy community dwellers. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Diseases
- What is being tested?
- Exergame
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 May 2017to 10 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy community dwellers Adult male and female participant's (≥65 years) Signed informed consent after being informed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Vestibular Diseases
- Being tested
- Exergame
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exergame | Experimental | 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. Receives: Other: Exergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Visual Acuity (DVA)
The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity
Measured: 30 minutes
Secondary outcomes (4)
Functional Gait Assessment (FGA)
The FGA is used to measure disturbances in balance and gait
Measured: 15 minutes
Extended Timed Get-Up-And-Go (ETGUG)
The time measured during each task and the overall time mirrors the functional mobility of the participant
Measured: 15 minutes
Gait speed
Time was measured in with a stopwatch as the participants walked in the central 6 m of the walkway.
Measured: 5 minutes
Simulator Sickness Questionnaire (SSQ)
The SSQ questionnaire assesses, cyber or virtual reality sickness
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start12 May 2017
- Primary completion25 Jun 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swanenburg Jaap, PhD, Principal investigator, University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160352
- Sponsor's protocol ID
- BASEC 2016-1220
- Status last verified
- May 2020
- First submitted
- 17 May 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication
Publications
Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.
PubMed 30108511
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Healthy Community Dwellers. A Pilot Study
- ClinicalTrials.gov ID
- NCT03160352
- Acronym / sponsor ID
- BASEC 2016-1220
- Conditions
- Vestibular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to assess the effects of virtual reality-based intervention on vestibular functions in healthy community dwellers.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exergame | Experimental | Other: ExergameThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy community dwellers Adult male and female participant's (≥65 years) Signed informed consent after being informed
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergameIn 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. | Other | Exergame |
Primary outcome
Dynamic Visual Acuity (DVA)
Time frame: 30 minutes
The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity
4 secondary outcomes
Functional Gait Assessment (FGA)
Time frame: 15 minutes
Extended Timed Get-Up-And-Go (ETGUG)
Time frame: 15 minutes
Gait speed
Time frame: 5 minutes
Simulator Sickness Questionnaire (SSQ)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 30108511Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.
- Individual participant dataSharing planned: No. Publication
Related trials for Vestibular Diseases
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Recruiting
Human Visual and Vestibular Motion Perception Study
Vestibular Disease
Not yet recruitingObservational study
Prevalence and Diagnosis of Persistent Postural-perceptual Dizziness
Persistent Postural-perceptual Dizziness
RecruitingObservational study
Vestibular and Postural Function in Children Suspected of Balance Disorders
Children, Only, Vestibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swanenburg Jaap, PhD principal investigator
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame in people with Vestibular Diseases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Visual Acuity (DVA) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020; AzTrials last refreshed its copy on 6 Nov 2026.