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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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Verticality Perception in Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. ages 18-90 years
  2. informed consent
  3. 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).
  4. absence of exclusion criteria

Exclusion Criteria:

  1. history of a peripheral-vestibular deficit
  2. disturbed consciousness
  3. severe sensory or motor aphasia
  4. visual field deficits
  5. other neurological or systemic disorder which can cause dementia or cognitive dysfunction
  6. 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

First Posted
July 3, 2014
Last Updated
January 6, 2020
Sponsor
University of Zurich
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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.
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Verticality Perception in Stroke Patients

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