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Effects of Exergames on Vestibular Function in Healthy Community Dwellers.

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

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

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

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
Gait speed
Time was measured in with a stopwatch as the participants walked in the central 6 m of the walkway.
Simulator Sickness Questionnaire (SSQ)
The SSQ questionnaire assesses, cyber or virtual reality sickness

Full Information

First Posted
May 17, 2017
Last Updated
May 18, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03160352
Brief Title
Effects of Exergames on Vestibular Function in Healthy Community Dwellers.
Official Title
Effects of a Virtual Reality-based Dual-task Exercise on Vestibular Function in Healthy Community Dwellers. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
June 25, 2017 (Actual)
Study Completion Date
July 10, 2017 (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 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.

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
Intervention Description
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.
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
30 minutes
Secondary Outcome Measure Information:
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
Gait speed
Description
Time was measured in with a stopwatch as the participants walked in the central 6 m of the walkway.
Time Frame
5 minutes
Title
Simulator Sickness Questionnaire (SSQ)
Description
The SSQ questionnaire assesses, cyber or virtual reality sickness
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swanenburg Jaap, 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
IPD Sharing Plan Description
Publication
Citations:
PubMed Identifier
30108511
Citation
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.
Results Reference
derived

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Effects of Exergames on Vestibular Function in Healthy Community Dwellers.

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