NCT03536533

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.

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 Aug 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

May 14, 2018

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

    15 minutes

Secondary Outcomes (9)

  • Video Head Impulse Test (vHIT)

    15 minutes

  • Suppression Head Impulse Paradigm (SHIMP)

    15 minutes

  • Subjective Visual Vertical test (SVV)

    15 minutes

  • Functional Gait Assessment (FGA)

    15 minutes

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

    15 minutes

  • +4 more secondary outcomes

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

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.

Also known as: SENSO Dividat
Exergame

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic peripheral unilateral vestibular hypofunction
  • Signed informed consent after being informed

You may not qualify if:

  • 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

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

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

  • Jaap Swanenburg, 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 14, 2018

First Posted

May 24, 2018

Study Start

August 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations