Verticality Perception in Stroke Patients
Primary Purpose
Verticality Perception in Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
presentation of visual vertical
Sponsored by
About this trial
This is an interventional basic science trial for Verticality Perception in Stroke
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
verticality measurements
Arm Description
Outcomes
Primary Outcome Measures
Accuracy of verticality perception
Secondary Outcome Measures
Test-re-test reliability of verticality perception
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184923
Brief Title
Verticality Perception in Stroke Patients
Official Title
Verticality Perception in Patients With Acute Lateralized Lesions Along the Central Graviceptive Pathways- Acute Assessment on the Ward and the Stroke Center
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verticality Perception in Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
verticality measurements
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
presentation of visual vertical
Primary Outcome Measure Information:
Title
Accuracy of verticality perception
Time Frame
during the measurement period (10 minutes)
Secondary Outcome Measure Information:
Title
Test-re-test reliability of verticality perception
Time Frame
from session 1 (day 0) to session 2 (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Straumann, MD
Organizational Affiliation
University Hospital Zurich, Division of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19433743
Citation
Zwergal A, Rettinger N, Frenzel C, Dieterich M, Brandt T, Strupp M. A bucket of static vestibular function. Neurology. 2009 May 12;72(19):1689-92. doi: 10.1212/WNL.0b013e3181a55ecf.
Results Reference
background
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Verticality Perception in Stroke Patients
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