Viewing Study NCT05978596



Ignite Creation Date: 2024-05-06 @ 7:20 PM
Last Modification Date: 2024-10-26 @ 3:05 PM
Study NCT ID: NCT05978596
Status: RECRUITING
Last Update Posted: 2023-08-07
First Post: 2023-06-20

Brief Title: Time Course of a Misperception of Verticality and Its Characteristics in Post-stroke Participants
Sponsor: Universiteit Antwerpen
Organization: Universiteit Antwerpen

Study Overview

Official Title: Postural Alignment in Post-stroke Participants Providing New Insights in the Time Course of a Misperception of Verticality and Its Characteristics
Status: RECRUITING
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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 eg 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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None