Gaze and Stair Walking in Patients With Vestibular Dysfunction

Vestibular Diseases Clinical Trial

— Gaze  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417545
• Other study ID #: KEK-ZH-2014-0509
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: October 24, 2016
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vestibular Diseases

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Gait	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	No
Secondary	Fall Calendar	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	No