Clinical trial NCT05978596: Time Course of a Misperception of Verticality and Its Characteristics in Post-stroke Participants
Official title: Postural Alignment in Post-stroke Participants: Providing New Insights in the Time Course of a Misperception of Verticality and Its Characteristics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Perception of verticality
Spatial neglect
Lateropulsion
Postural control
Subjective Visual Vertical
Subjective Haptic Vertical
Subjective Postural Vertical
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from rehabiliation hospital RevArte (Edegem) and AZ Monica (Antwerp).

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Subjective Visual Vertical constant error
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Visual Vertical constant error
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Visual Vertical constant error
timeFrame: Change from 8 to 12
measure: Change in Subjective Hapic Vertical constant error
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Hapic Vertical constant error
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Hapic Vertical constant error
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Postural Vertical constant error
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Postural Vertical constant error
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Postural Vertical constant error
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Visual Vertical unsigned error
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Visual Vertical unsigned error
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Visual Vertical unsigned error
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Haptic Vertical unsigned error
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Haptic Vertical unsigned error
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Haptic Vertical unsigned error
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Postural Vertical unsigned error
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Postural Vertical unsigned error
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Postural Vertical unsigned error
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Visual Vertical variability
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Visual Vertical variability
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Visual Vertical variability
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Haptic Vertical variability
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Haptic Vertical variability
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Haptic Vertical variability
timeFrame: Change from 8 to 12 weeks
measure: Change in Subjective Postural Vertical variability
timeFrame: Change from 3 to 5 weeks
measure: Change in Subjective Postural Vertical variability
timeFrame: Change from 5 to 8 weeks
measure: Change in Subjective Postural Vertical variability
timeFrame: Change from 8 to 12 weeks
Secondary outcomes:
measure: Trunk Control Test - item quiet siting for 30 seconds
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Berg Balance Scale - item quiet standing for 2 minutes
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Motricity index - lower limbs
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Line Bisection Test
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Visuospatial Search Time Test
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Fluff test
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Tactile extinction test
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Burke Lateropulsion Scale
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Scale for Contraversive Pushing
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Trunk Impairment test (dynamic and coordination subscales)
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Weight bearing asymmetry (standing)
timeFrame: 3, 5, 8, 12 weeks post-stroke
measure: Broken Heart Test
timeFrame: 3, 5, 8, 12 weeks post-stroke
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: AZ Monica
city: Edegem
country: Belgium
facility: RevArte
Study officials:
affiliation: Universiteit Antwerpen
name: Wim Saeys, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.