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Completed

NCT Number: NCT02417545

Gaze and Stair Walking in Patients With Vestibular Dysfunction

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).

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Key information

Conditions

Vestibular Diseases Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: Gaze

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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