NCT02417545

Brief Summary

The aim of this study is to assess the differences in gaze and gait during the stair and ramp negotiation (+transition to normal level walking) between healthy controls and vestibular patients (fallers and non-fallers).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

April 10, 2015

Last Update Submit

October 24, 2016

Conditions

Vestibular Diseases

Outcome Measures

Primary Outcomes (1)

  • Gaze

    A mobile eye tracker (Dikablis Professional Glasses, Ergoneers Inc., Manching, Germany) was used to record gaze during the stairs and ramp negotiation.

    30 minutes

Secondary Outcomes (2)

  • Gait

    30 minutes

  • Fall Calendar

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study sample includs patients with vestibular disorder and age matched healthy participants. Patients with vestibular disorder will be diagnosed by a pathological horizontal head impulse test to both sides (\< 0.80), as assessed by using a video-based system and the presents of saccades.

You may qualify if:

  • All included patients are diagnosed with single or two-sided vestibular dysfunction.
  • Adult male and female participant's (≥18 years)
  • Signed informed consent after being informed

You may not qualify if:

  • Benign paroxysmal positional vertigo
  • Acute pain
  • Walking disability (independent walking distance \<10 meters)
  • Uncontrolled cardiovascular disease (e.g.: uncontrolled blood pressure)
  • Gait problems caused by Hip or knee endoprothesis
  • Weakness due to neurological problems
  • Known or suspected non-compliance
  • Contraindications on ethical grounds

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

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jaap Swanenburg, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 15, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2015

Study Completion

September 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Publication

Locations

CH(1)