NCT03160352

Brief Summary

The aim is to assess the effects of virtual reality-based intervention on vestibular functions in healthy community dwellers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

May 17, 2017

Last Update Submit

May 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic Visual Acuity (DVA)

    The DVA is the measurement of visual acuity during head movement relative to baseline static visual acuity

    30 minutes

Secondary Outcomes (4)

  • Functional Gait Assessment (FGA)

    15 minutes

  • Extended Timed Get-Up-And-Go (ETGUG)

    15 minutes

  • Gait speed

    5 minutes

  • Simulator Sickness Questionnaire (SSQ)

    5 minutes

Study Arms (1)

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.

Other: Exergame

Interventions

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.

Exergame

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy community dwellers Adult male and female participant's (≥65 years) Signed informed consent after being informed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Swanenburg Jaap, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

May 12, 2017

Primary Completion

June 25, 2017

Study Completion

July 10, 2017

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Publication

Locations