Time Course of a Misperception of Verticality and Its Characteristics in Post-stroke Participants

August 4, 2023 updated by: Wim Saeys, Universiteit Antwerpen

Postural Alignment in Post-stroke Participants: Providing New Insights in the Time Course of a Misperception of Verticality and Its Characteristics

Little is known about the time course of verticality perception after stroke. This study aims to assess:

  • The time course of verticality perception (Subjective Visual, Haptic and Postural Vertical; resp., SVV, SHV, SPV);
  • The longitudinal interaction of the recovery of spatial disorders (e.g., different types of neglect, lateropulsion) with verticality perception;
  • The longitudinal interaction of motor function and outcomes (such as paresis, sitting balance and standing balance) and verticality perception.

The participants will be repetitively assessed during the subacute phase post-stroke, to evaluate the time course of:

  • The SVV, SHV and SPV;
  • Spatial disorders (visuospatial and personal neglect, lateropulsion)
  • Motor function (lower limb strength, sitting and standing balance, functionality in ADL, trunk performance)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

For a correct vertical alignment of the body with the gravitational vector, the patient must be able to accurately perceive verticality. Estimation of verticality is a complex process, suggested to be based on internal references derived from the integration of multisensory input (e.g. visual, vestibular and somatosensory). Due to a brain lesion, this complex process can be hampered, resulting in a deviation of the subjective vertical.

Different modalities of verticality perception can be assessed, including the Subjective Visual (SVV), Haptic (SHV) and Postural (SPV) Vertical. Previous studies reported a deviation of the subjective vertical in post-stroke patients. These deviations are associated with poorer balance performance. However, some stroke participants have more difficulties with accurately estimating a vertical position as compared to others. This increased magnitude is often seen in participants with lateropulsion or spatial neglect.

Although previous studies showed an increased deviation of the subjective vertical in post-stroke patients, little is known about the recovery of this misperception of verticality. Especially in patients with spatial disorders (e.g., lateropulsion or (different subtypes of) neglect), there is clear lack of studies assessing the longitudinal recovery of a misperception of verticality. Knowledge about the spontaneous recovery of a deviated verticality perception and its association with spatial disorders, will give insights in the role of a misperception of verticality in these disorders.

Although disturbances in perceiving verticality and decreased balance performance seems to be related, it is unclear how these disturbances exactly impacts balance and functional outcome. A longitudinal interaction between verticality perception and motor function will be evaluated.

Participants will be recruited from rehabilitation hospital Revarte (Edegem) or AZ Monica (Antwerp). Participants will be included at 3 or 5 weeks post-stroke and evaluation will take place at 3, 5, 8 and 12 weeks post-stroke. Also, in healthy participants the SVV, SHV and SPV will be evaluated to obtain normative data.

The outcome measures contain:

  • Perception of verticality: SVV, SHV, SPV;
  • Combination of pen-and-paper tasks and computerized tests to asses visuospatial and personal neglect;
  • Clinical scales to evaluate lateropulsion;
  • Clinical scales to evaluate motor function (lower limb strength, sitting balance, standing balance, functionality in ADL, trunk performance);
  • Instrumented analysis to assess sitting and standing balance.

For the data-analysis Linear Mixed Models will be used, to evaluate study results and mean change over time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants will be recruited from rehabiliation hospital RevArte (Edegem) and AZ Monica (Antwerp).

Description

Inclusion Criteria:

  • First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic supratentorial stroke;
  • Able to give written informed consent.

Exclusion Criteria:

  • Bilateral lesions;
  • Vestibular dysfunction, symptomatic orthostatic hypotension or other pre-existing neurological conditions that could interfere with the assessments;
  • Inability to understand and follow basic verbal instructions;
  • Hemianopsia or other visual field deficits (glasses or corrective lenses are allowed)

And a group of healthy controls to obtain normative data. These participants are eligible for inclusion if they are between 18 and 90 years old and do not suffer from vestibular dysfunction, symptomatic orthostatic hypotension or other neurological conditions that could interfere with the assessment.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Subjective Visual Vertical constant error
Time Frame: Change from 3 to 5 weeks
Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 3 to 5 weeks
Change in Subjective Visual Vertical constant error
Time Frame: Change from 5 to 8 weeks
Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 5 to 8 weeks
Change in Subjective Visual Vertical constant error
Time Frame: Change from 8 to 12
Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 8 to 12
Change in Subjective Hapic Vertical constant error
Time Frame: Change from 3 to 5 weeks
Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 3 to 5 weeks
Change in Subjective Hapic Vertical constant error
Time Frame: Change from 5 to 8 weeks
Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 5 to 8 weeks
Change in Subjective Hapic Vertical constant error
Time Frame: Change from 8 to 12 weeks
Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 8 to 12 weeks
Change in Subjective Postural Vertical constant error
Time Frame: Change from 3 to 5 weeks
Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 3 to 5 weeks
Change in Subjective Postural Vertical constant error
Time Frame: Change from 5 to 8 weeks
Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 5 to 8 weeks
Change in Subjective Postural Vertical constant error
Time Frame: Change from 8 to 12 weeks
Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Change from 8 to 12 weeks
Change in Subjective Visual Vertical unsigned error
Time Frame: Change from 3 to 5 weeks
Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
Change from 3 to 5 weeks
Change in Subjective Visual Vertical unsigned error
Time Frame: Change from 5 to 8 weeks
Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
Change from 5 to 8 weeks
Change in Subjective Visual Vertical unsigned error
Time Frame: Change from 8 to 12 weeks
Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
Change from 8 to 12 weeks
Change in Subjective Haptic Vertical unsigned error
Time Frame: Change from 3 to 5 weeks
Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
Change from 3 to 5 weeks
Change in Subjective Haptic Vertical unsigned error
Time Frame: Change from 5 to 8 weeks
Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
Change from 5 to 8 weeks
Change in Subjective Haptic Vertical unsigned error
Time Frame: Change from 8 to 12 weeks
Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
Change from 8 to 12 weeks
Change in Subjective Postural Vertical unsigned error
Time Frame: Change from 3 to 5 weeks
Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
Change from 3 to 5 weeks
Change in Subjective Postural Vertical unsigned error
Time Frame: Change from 5 to 8 weeks
Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
Change from 5 to 8 weeks
Change in Subjective Postural Vertical unsigned error
Time Frame: Change from 8 to 12 weeks
Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
Change from 8 to 12 weeks
Change in Subjective Visual Vertical variability
Time Frame: Change from 3 to 5 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 3 to 5 weeks
Change in Subjective Visual Vertical variability
Time Frame: Change from 5 to 8 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 5 to 8 weeks
Change in Subjective Visual Vertical variability
Time Frame: Change from 8 to 12 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 8 to 12 weeks
Change in Subjective Haptic Vertical variability
Time Frame: Change from 3 to 5 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 3 to 5 weeks
Change in Subjective Haptic Vertical variability
Time Frame: Change from 5 to 8 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 5 to 8 weeks
Change in Subjective Haptic Vertical variability
Time Frame: Change from 8 to 12 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 8 to 12 weeks
Change in Subjective Postural Vertical variability
Time Frame: Change from 3 to 5 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 3 to 5 weeks
Change in Subjective Postural Vertical variability
Time Frame: Change from 5 to 8 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 5 to 8 weeks
Change in Subjective Postural Vertical variability
Time Frame: Change from 8 to 12 weeks
Reflects the intra-individual variability (standard deviation of the trials)
Change from 8 to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trunk Control Test - item quiet siting for 30 seconds
Time Frame: 3, 5, 8, 12 weeks post-stroke
Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance.
3, 5, 8, 12 weeks post-stroke
Berg Balance Scale - item quiet standing for 2 minutes
Time Frame: 3, 5, 8, 12 weeks post-stroke
Ability to stand unsupported. Score from 0 to 4. Higher score means better performance.
3, 5, 8, 12 weeks post-stroke
Motricity index - lower limbs
Time Frame: 3, 5, 8, 12 weeks post-stroke
Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)
3, 5, 8, 12 weeks post-stroke
Line Bisection Test
Time Frame: 3, 5, 8, 12 weeks post-stroke
Visuospatial neglect test
3, 5, 8, 12 weeks post-stroke
Visuospatial Search Time Test
Time Frame: 3, 5, 8, 12 weeks post-stroke
Visuospatial neglect test
3, 5, 8, 12 weeks post-stroke
Fluff test
Time Frame: 3, 5, 8, 12 weeks post-stroke
Personal neglect test
3, 5, 8, 12 weeks post-stroke
Tactile extinction test
Time Frame: 3, 5, 8, 12 weeks post-stroke
Personal neglect test
3, 5, 8, 12 weeks post-stroke
Burke Lateropulsion Scale
Time Frame: 3, 5, 8, 12 weeks post-stroke
Lateropulsion test. Score from 0-17.
3, 5, 8, 12 weeks post-stroke
Scale for Contraversive Pushing
Time Frame: 3, 5, 8, 12 weeks post-stroke
Lateropulsion test. Score 0-6.
3, 5, 8, 12 weeks post-stroke
Trunk Impairment test (dynamic and coordination subscales)
Time Frame: 3, 5, 8, 12 weeks post-stroke
Test to evaluate the dynamic and coordinative performance of the trunk
3, 5, 8, 12 weeks post-stroke
Weight bearing asymmetry (standing)
Time Frame: 3, 5, 8, 12 weeks post-stroke
Difference in weight bearing (paretic vs non-paretic) in percentage
3, 5, 8, 12 weeks post-stroke
Broken Heart Test
Time Frame: 3, 5, 8, 12 weeks post-stroke
Change in cancellation task for visuospatial neglect
3, 5, 8, 12 weeks post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wim Saeys, Prof. Dr., Universiteit Antwerpen

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CvdW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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