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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978596
• Other study ID #: CvdW
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Universiteit Antwerpen
• Contact: Charlotte van der Waal, MSc
• Phone: +3232659724
• Email: charlotte.vanderwaal[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Belgium	AZ Monica	Antwerp
Belgium	RevArte	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Subjective Visual Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 3 to 5 weeks
Primary	Change in Subjective Visual Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 5 to 8 weeks
Primary	Change in Subjective Visual Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 8 to 12 weeks
Primary	Change in Subjective Haptic Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 3 to 5 weeks
Primary	Change in Subjective Haptic Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 5 to 8 weeks
Primary	Change in Subjective Haptic Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 8 to 12 weeks
Primary	Change in Subjective Postural Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 3 to 5 weeks
Primary	Change in Subjective Postural Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 5 to 8 weeks
Primary	Change in Subjective Postural Vertical variability	Reflects the intra-individual variability (standard deviation of the trials)	Change from 8 to 12 weeks
Secondary	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.	3, 5, 8, 12 weeks post-stroke
Secondary	Berg Balance Scale - item quiet standing for 2 minutes	Ability to stand unsupported. Score from 0 to 4. Higher score means better performance.	3, 5, 8, 12 weeks post-stroke
Secondary	Motricity index - lower limbs	Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)	3, 5, 8, 12 weeks post-stroke
Secondary	Line Bisection Test	Visuospatial neglect test	3, 5, 8, 12 weeks post-stroke
Secondary	Visuospatial Search Time Test	Visuospatial neglect test	3, 5, 8, 12 weeks post-stroke
Secondary	Fluff test	Personal neglect test	3, 5, 8, 12 weeks post-stroke
Secondary	Tactile extinction test	Personal neglect test	3, 5, 8, 12 weeks post-stroke
Secondary	Burke Lateropulsion Scale	Lateropulsion test. Score from 0-17.	3, 5, 8, 12 weeks post-stroke
Secondary	Scale for Contraversive Pushing	Lateropulsion test. Score 0-6.	3, 5, 8, 12 weeks post-stroke
Secondary	Trunk Impairment test (dynamic and coordination subscales)	Test to evaluate the dynamic and coordinative performance of the trunk	3, 5, 8, 12 weeks post-stroke
Secondary	Weight bearing asymmetry (standing)	Difference in weight bearing (paretic vs non-paretic) in percentage	3, 5, 8, 12 weeks post-stroke
Secondary	Broken Heart Test	Change in cancellation task for visuospatial neglect	3, 5, 8, 12 weeks post-stroke