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Gaze and Stair Walking in Patients With Vestibular Dysfunction

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT02417545
Collaborator
(none)
48
Enrollment
1
Location
19
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    48 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Gaze and Movement Behavior of Patients With Vestibular Dysfunction During Level Floor, Ramp, and Stair Walking
    Study Start Date :
    Feb 1, 2015
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Sep 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Gaze [30 minutes]

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

    Secondary Outcome Measures

    1. Gait [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.

    2. Fall Calendar [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research Zurich ZH Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Principal Investigator: Jaap Swanenburg, PhD, University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02417545
    Other Study ID Numbers:
    • KEK-ZH-2014-0509
    First Posted:
    Apr 15, 2015
    Last Update Posted:
    Oct 25, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Vestibular Diseases

    Study Results

    No Results Posted as of Oct 25, 2016