Vestibular DiseasesGazeNCT02417545
Gaze and Stair Walking in Patients With Vestibular Dysfunction
An observational study of Vestibular Diseases, run by University of Zurich at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Diseases
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Zurich, Canton of Zurich, 8091
About this study
Official title: 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).
Read the 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.
- Conditions
- Vestibular Diseases
- Medical subject headings
- Vestibular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaze
A mobile eye tracker (Dikablis Professional Glasses, Ergoneers Inc., Manching, Germany) was used to record gaze during the stairs and ramp negotiation.
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 30 minutes
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417545
- Sponsor's protocol ID
- KEK-ZH-2014-0509
- Acronym
- Gaze
- Status last verified
- Oct 2016
- First submitted
- 10 Apr 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze and Movement Behavior of Patients With Vestibular Dysfunction During Level Floor, Ramp, and Stair Walking
- ClinicalTrials.gov ID
- NCT02417545
- Acronym / sponsor ID
- Gaze / KEK-ZH-2014-0509
- Conditions
- Vestibular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Gait
Time frame: 30 minutes
Fall Calendar
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Yes. Publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanenburg, PhD principal investigator
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Diseases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gaze (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.