NCT05978596

Brief 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 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

June 20, 2023

Last Update Submit

August 4, 2023

Conditions

Keywords

Perception of verticalitySpatial neglectLateropulsionPostural controlSubjective Visual VerticalSubjective Haptic VerticalSubjective Postural Vertical

Outcome Measures

Primary Outcomes (27)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Change from 8 to 12 weeks

  • Change in Subjective Visual Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 3 to 5 weeks

  • Change in Subjective Visual Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 5 to 8 weeks

  • Change in Subjective Visual Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 8 to 12 weeks

  • Change in Subjective Haptic Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 3 to 5 weeks

  • Change in Subjective Haptic Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 5 to 8 weeks

  • Change in Subjective Haptic Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 8 to 12 weeks

  • Change in Subjective Postural Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 3 to 5 weeks

  • Change in Subjective Postural Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 5 to 8 weeks

  • Change in Subjective Postural Vertical variability

    Reflects the intra-individual variability (standard deviation of the trials)

    Change from 8 to 12 weeks

Secondary Outcomes (12)

  • Trunk Control Test - item quiet siting for 30 seconds

    3, 5, 8, 12 weeks post-stroke

  • Berg Balance Scale - item quiet standing for 2 minutes

    3, 5, 8, 12 weeks post-stroke

  • Motricity index - lower limbs

    3, 5, 8, 12 weeks post-stroke

  • Line Bisection Test

    3, 5, 8, 12 weeks post-stroke

  • Visuospatial Search Time Test

    3, 5, 8, 12 weeks post-stroke

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Monica

Antwerp, 2018, Belgium

RECRUITING

RevArte

Edegem, 2650, Belgium

RECRUITING

Related Publications (5)

  • 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.

    PMID: 35102816BACKGROUND
  • Embrechts 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.

    PMID: 35963568BACKGROUND
  • Perennou 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.

    PMID: 18678565BACKGROUND
  • Bonan 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.

    PMID: 17082504BACKGROUND
  • van 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wim Saeys, Prof. Dr.

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte van der Waal, MSc

CONTACT

Wim Saeys, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Wim Saeys

Study Record Dates

First Submitted

June 20, 2023

First Posted

August 7, 2023

Study Start

October 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations