Gaze and Stair Walking in Patients With Vestibular Dysfunction (Gaze)

October 24, 2016 updated by: University of Zurich

Gaze and Movement Behavior of Patients With Vestibular Dysfunction During Level Floor, Ramp, and Stair Walking

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).

Study Overview

Status

Completed

Conditions

Detailed Description

For a better understanding of falls in patients with vestibular disorders it might be important to identify the challenging environmental that provoke functional deficits; e.g. stair or ramp negotiation. The three steps at the ground and at the top of stairs is the most common location for missteps and stair accidents. This is supported by the observation made in a 12-month prospective study were 32% of the falls happened during the last step going down stairs in vestibular patients.

It remains open if patient's vestibular dysfunctions have a different gaze or gait behavior than healthy individuals.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gaze
Time Frame: 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait
Time Frame: 30 minutes
The recording gait system is a pair of inlay soles with sensors. The sensors sampled the force distribution beneath the subjects' feet. The inlay soles are recording acceleration, rotation rates and magnetic field readings, each in 3 dimensions.
30 minutes
Fall Calendar
Time Frame: one year
A fall-Calendar with questions will be used to assess falls. These questions will be placed on each page of a 12 month calendar. The "fall calendar" pages also contain questions about the circumstances surrounding falls, including the day time, lighting situation, fall location, activity performed, injuries and whether medical assistance was needed. As soon as possible after the fall the fallers have to fill in the date of the fall, its cause, and fall-related injuries. At the end of each month, a calendar page should be sent by each patient to the investigators.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • KEK-ZH-2014-0509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vestibular Diseases

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