- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184923
Verticality Perception in Stroke Patients
January 6, 2020 updated by: University of Zurich
Verticality Perception in Patients With Acute Lateralized Lesions Along the Central Graviceptive Pathways- Acute Assessment on the Ward and the Stroke Center
The long-term goal of this research is to advance our knowledge of how information from the labyrinth is brought to perception and how adaptation to vestibular imbalance influences spatial orientation.
In healthy human subjects verticality perception is accurate while upright.The strategy of this research is to quantify changes in verticality perception after unilateral lesions along the central graviceptive pathways and to assess the frequency and pattern of abnormal verticality perception in patients with acute stroke (ischemic or hemorrhagic).
Our underlying hypothesis is that screening for erroneous verticality perception by use of a mobile device assessing the subjective visual vertical (SVV) during the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those patients with defects.
Early detection of deficits in verticality perception may help to initiate balance physiotherapy early.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
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
-
-
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 to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ages 18-90 years
- informed consent
- for group 1: acute (i.e. symptom onset <3 days ago) lateralized ischemia or hemorrhage as confirmed by clinical examination and / or brain imaging (CT or MRI).
- absence of exclusion criteria
Exclusion Criteria:
- history of a peripheral-vestibular deficit
- disturbed consciousness
- severe sensory or motor aphasia
- visual field deficits
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- intake of antidepressants, sedatives, or neuroleptics
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
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: verticality measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Accuracy of verticality perception
Time Frame: during the measurement period (10 minutes)
|
during the measurement period (10 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Test-re-test reliability of verticality perception
Time Frame: from session 1 (day 0) to session 2 (day 1)
|
from session 1 (day 0) to session 2 (day 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dominik Straumann, MD, University Hospital Zurich, Division of Neurology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
August 1, 2014
Primary Completion (Actual)
December 31, 2017
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
July 3, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 9, 2014
Study Record Updates
Last Update Posted (Actual)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- verticality_percept_stroke_zrh
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.
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