StrokeNCT05978596
Time Course of a Misperception of Verticality and Its Characteristics in Post-stroke Participants
An observational study of Stroke, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Oct 2021to Dec 2024
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from rehabiliation hospital RevArte (Edegem) and AZ Monica (Antwerp).
Who may be able to join
- First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic supratentorial stroke;
- Able to give written informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Wim Saeys, Prof. Dr. contact
Belgium2 sites, 2 recruiting
- Recruiting
AZ Monica
Antwerp, 2018
Charlotte van der Waal, charlotte.vanderwaal@uantwerpen.be
Jelena Warmenbol
- Recruiting
RevArte
Edegem, 2650
Charlotte van der Waal, MSc, charlotte.vanderwaal@uantwerpen.be
Wim Saeys, Dr
About this study
Official title: 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.
Read more
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)
Read the 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.
- Conditions
- Stroke
- Keywords
- Perception of verticality, Spatial neglect, Lateropulsion, Postural control, Subjective Visual Vertical, Subjective Haptic Vertical, Subjective Postural Vertical
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective Visual Vertical constant error
Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 3 to 5 weeks
Change in Subjective Visual Vertical constant error
Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 5 to 8 weeks
Change in Subjective Visual Vertical constant error
Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 8 to 12
Change in Subjective Hapic Vertical constant error
Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 3 to 5 weeks
Change in Subjective Hapic Vertical constant error
Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 5 to 8 weeks
Change in Subjective Hapic Vertical constant error
Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 8 to 12 weeks
Change in Subjective Postural Vertical constant error
Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 3 to 5 weeks
Change in Subjective Postural Vertical constant error
Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 5 to 8 weeks
Change in Subjective Postural Vertical constant error
Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
Measured: Change from 8 to 12 weeks
Change in Subjective Visual Vertical unsigned error
Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 3 to 5 weeks
Change in Subjective Visual Vertical unsigned error
Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 5 to 8 weeks
Change in Subjective Visual Vertical unsigned error
Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 8 to 12 weeks
Change in Subjective Haptic Vertical unsigned error
Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 3 to 5 weeks
Change in Subjective Haptic Vertical unsigned error
Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 5 to 8 weeks
Change in Subjective Haptic Vertical unsigned error
Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 8 to 12 weeks
Change in Subjective Postural Vertical unsigned error
Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 3 to 5 weeks
Change in Subjective Postural Vertical unsigned error
Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 5 to 8 weeks
Change in Subjective Postural Vertical unsigned error
Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
Measured: Change from 8 to 12 weeks
Change in Subjective Visual Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 3 to 5 weeks
Change in Subjective Visual Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 5 to 8 weeks
Change in Subjective Visual Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 8 to 12 weeks
Change in Subjective Haptic Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 3 to 5 weeks
Change in Subjective Haptic Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 5 to 8 weeks
Change in Subjective Haptic Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 8 to 12 weeks
Change in Subjective Postural Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 3 to 5 weeks
Change in Subjective Postural Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 5 to 8 weeks
Change in Subjective Postural Vertical variability
Reflects the intra-individual variability (standard deviation of the trials)
Measured: Change from 8 to 12 weeks
Secondary outcomes (12)
Trunk Control Test - item quiet siting for 30 seconds
Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance.
Measured: 3, 5, 8, 12 weeks post-stroke
Berg Balance Scale - item quiet standing for 2 minutes
Ability to stand unsupported. Score from 0 to 4. Higher score means better performance.
Measured: 3, 5, 8, 12 weeks post-stroke
Motricity index - lower limbs
Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)
Measured: 3, 5, 8, 12 weeks post-stroke
Line Bisection Test
Visuospatial neglect test
Measured: 3, 5, 8, 12 weeks post-stroke
Visuospatial Search Time Test
Visuospatial neglect test
Measured: 3, 5, 8, 12 weeks post-stroke
Fluff test
Personal neglect test
Measured: 3, 5, 8, 12 weeks post-stroke
Tactile extinction test
Personal neglect test
Measured: 3, 5, 8, 12 weeks post-stroke
Burke Lateropulsion Scale
Lateropulsion test. Score from 0-17.
Measured: 3, 5, 8, 12 weeks post-stroke
Scale for Contraversive Pushing
Lateropulsion test. Score 0-6.
Measured: 3, 5, 8, 12 weeks post-stroke
Trunk Impairment test (dynamic and coordination subscales)
Test to evaluate the dynamic and coordinative performance of the trunk
Measured: 3, 5, 8, 12 weeks post-stroke
Weight bearing asymmetry (standing)
Difference in weight bearing (paretic vs non-paretic) in percentage
Measured: 3, 5, 8, 12 weeks post-stroke
Broken Heart Test
Change in cancellation task for visuospatial neglect
Measured: 3, 5, 8, 12 weeks post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Oct 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Saeys, Universiteit Antwerpen
- Investigators
- Wim Saeys, Prof. Dr., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978596
- Sponsor's protocol ID
- CvdW
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Waal C, Embrechts E, Loureiro-Chaves R, Gebruers N, Truijen S, Saeys W. Lateropulsion with active pushing in stroke patients: its link with lesion location and the perception of verticality. A systematic review. Top Stroke Rehabil. 2023 Apr;30(3):281-297. doi: 10.1080/10749357.2022.2026563. Epub 2022 Feb 1.
PubMed 35102816Embrechts E, van der Waal C, Anseeuw D, van Buijnderen J, Leroij A, Lafosse C, Nijboer TC, Truijen S, Saeys W. Association between spatial neglect and impaired verticality perception after stroke: A systematic review. Ann Phys Rehabil Med. 2023 Apr;66(3):101700. doi: 10.1016/j.rehab.2022.101700. Epub 2022 Dec 1.
PubMed 35963568Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
PubMed 18678565Bonan IV, Leman MC, Legargasson JF, Guichard JP, Yelnik AP. Evolution of subjective visual vertical perturbation after stroke. Neurorehabil Neural Repair. 2006 Dec;20(4):484-91. doi: 10.1177/1545968306289295.
PubMed 17082504van der Waal C, Saeys W, Truijen S, Embrechts E. Clinical Assessment of Subjective Visual and Haptic Vertical Norms in Healthy Adults. Arch Clin Neuropsychol. 2024 Nov 22;39(8):1408-1417. doi: 10.1093/arclin/acae049.
PubMed 38940374
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Alignment in Post-stroke Participants: Providing New Insights in the Time Course of a Misperception of Verticality and Its Characteristics
- ClinicalTrials.gov ID
- NCT05978596
- Acronym / sponsor ID
- CvdW
- Conditions
- Stroke
- Keywords
- Perception of verticality, Spatial neglect, Lateropulsion, Postural control, Subjective Visual Vertical, Subjective Haptic Vertical, Subjective Postural Vertical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- 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.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from rehabiliation hospital RevArte (Edegem) and AZ Monica (Antwerp).
Key inclusion criteria (2 listed)
- First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic supratentorial stroke;
- Able to give written informed consent.
Key exclusion criteria (5 listed)
- 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.
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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 in Subjective Visual Vertical variability
Time frame: Change from 3 to 5 weeks
Reflects the intra-individual variability (standard deviation of the trials)
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 in Subjective Visual Vertical variability
Time frame: Change from 8 to 12 weeks
Reflects the intra-individual variability (standard deviation of the trials)
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 in Subjective Haptic Vertical variability
Time frame: Change from 5 to 8 weeks
Reflects the intra-individual variability (standard deviation of the trials)
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 in Subjective Postural Vertical variability
Time frame: Change from 3 to 5 weeks
Reflects the intra-individual variability (standard deviation of the trials)
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 in Subjective Postural Vertical variability
Time frame: Change from 8 to 12 weeks
Reflects the intra-individual variability (standard deviation of the trials)
12 secondary outcomes
Trunk Control Test - item quiet siting for 30 seconds
Time frame: 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
Motricity index - lower limbs
Time frame: 3, 5, 8, 12 weeks post-stroke
Line Bisection Test
Time frame: 3, 5, 8, 12 weeks post-stroke
Visuospatial Search Time Test
Time frame: 3, 5, 8, 12 weeks post-stroke
Fluff test
Time frame: 3, 5, 8, 12 weeks post-stroke
Tactile extinction test
Time frame: 3, 5, 8, 12 weeks post-stroke
Burke Lateropulsion Scale
Time frame: 3, 5, 8, 12 weeks post-stroke
Scale for Contraversive Pushing
Time frame: 3, 5, 8, 12 weeks post-stroke
Trunk Impairment test (dynamic and coordination subscales)
Time frame: 3, 5, 8, 12 weeks post-stroke
Weight bearing asymmetry (standing)
Time frame: 3, 5, 8, 12 weeks post-stroke
Broken Heart Test
Time frame: 3, 5, 8, 12 weeks post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 35102816van der Waal C, Embrechts E, Loureiro-Chaves R, Gebruers N, Truijen S, Saeys W. Lateropulsion with active pushing in stroke patients: its link with lesion location and the perception of verticality. A systematic review. Top Stroke Rehabil. 2023 Apr;30(3):281-297. doi: 10.1080/10749357.2022.2026563. Epub 2022 Feb 1.
- Background: PubMed 35963568Embrechts E, van der Waal C, Anseeuw D, van Buijnderen J, Leroij A, Lafosse C, Nijboer TC, Truijen S, Saeys W. Association between spatial neglect and impaired verticality perception after stroke: A systematic review. Ann Phys Rehabil Med. 2023 Apr;66(3):101700. doi: 10.1016/j.rehab.2022.101700. Epub 2022 Dec 1.
- Background: PubMed 18678565Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
- Background: PubMed 17082504Bonan IV, Leman MC, Legargasson JF, Guichard JP, Yelnik AP. Evolution of subjective visual vertical perturbation after stroke. Neurorehabil Neural Repair. 2006 Dec;20(4):484-91. doi: 10.1177/1545968306289295.
- Derived from this study: PubMed 38940374van der Waal C, Saeys W, Truijen S, Embrechts E. Clinical Assessment of Subjective Visual and Haptic Vertical Norms in Healthy Adults. Arch Clin Neuropsychol. 2024 Nov 22;39(8):1408-1417. doi: 10.1093/arclin/acae049.
- Individual participant dataSharing planned: Undecided
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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.
Wim Saeys, Prof. Dr. contact
Wim Saeys, Prof. Dr. principal investigator
Universiteit Antwerpen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Universiteit Antwerpen at 2 sites in Belgium.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte van der Waal, MSc (+3232659724, charlotte.vanderwaal@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Visual Vertical constant error (time frame: Change from 3 to 5 weeks). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05978596, which also lists 5 linked publications.
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 7 Aug 2023.