Increasing Insight in Spatial Neglect: Unraveling Its Longitudinal Interaction With Motor Function After Stroke

Goal: Various studies suggest a negative association between spatial neglect and motor outcomes after stroke (Barrett & Muzaffar 2014) (Kwakkel 2014). Our goal is to assess:

• The longitudinal interaction of the recovery of spatial neglect with the recovery of motor function and outcomes (such as paresis, sitting balance and standing balance)
• Whether the association is different across the different subtypes of spatial neglect (visuospatial/personal/ADL-related)
• The role of compensation strategies for balance control in patients with spatial neglect

To do so, we will perform a longitudinal cohort study in which we will repetitively assess post-stroke patients using a comprehensive assessment approach for both spatial neglect and motor outcomes. With regards to neglect, we will evaluate various aspects of both visuospatial and personal neglect. For motor outcomes, we will combine clinical and instrumented (biomechanical) assessment methods to evaluate post-stroke recovery of leg paresis, (sitting and standing) balance and gait.

Study Overview

• Status: Completed
• Conditions: Stroke; Spatial Neglect; Postural Control
• Intervention / Treatment: Other: No intervention

Detailed Description

Spatial neglect is a post-stroke disorder characterized by impaired awareness for stimuli located on the contralesional side of space. This neglect results in problems with reporting, responding or orienting toward contralesional stimuli, which cannot be explained by sensory or motor impairments. It can be present after a right- or left-sided brain lesion but is more frequently present in right-sided brain lesions. Within the first 2 weeks post-stroke, it occurs in approximately 50% of patients. Spontaneous neurological recovery of neglect follows a natural logistic pattern of improvement within the first 12 to 14 weeks post-stroke. Afterward, the curve flattens and the severity remains merely invariant, leaving 40% of patients with initial neglect still with symptoms at 1 year post-stroke.

The high frequency and persistence of spatial neglect might have major consequences; indeed, various studies suggest a negative association between spatial neglect and post-stroke recovery of motor function and abilities. Apart from the seemingly suppressive influence of VSN on the recovery of upper-limb strength and synergy acquisition, lower limb motor recovery, balance and functional mobility might also be affected. However, the longitudinal interactions between spatial neglect and lower limb motor recovery are complex and only partially understood, owing to a lack of prospective cohort studies evaluating this. Additionally, also the association between spatial neglect and balance and functional mobility is currently unclear. A comprehensive overview is lacking, even though both balance and functional mobility are likely to be affected in these patients. Indeed, spatial neglect is characterised by a spatial (orientational) bias of attention. This bias might reflect a disruption in spatial information processing, which is a neural process incorporating sensory information from multiple modalities, resolving sensory ambiguity and integrating afferent and efferent information. A bias in this information processing might impede postural control and therefore also balance and mobility. However, whether spatial neglect and these motor outcomes are longitudinally associated, and whether such association is similar for the different spatial neglect subtypes, is still unknown.

Our goal is to assess:

• The longitudinal interaction of the recovery of spatial neglect with the recovery of motor function and outcomes (such as paresis, sitting balance and standing balance)
• Whether the association is different across the different subtypes of spatial neglect (visuospatial/personal/ADL-related)
• The role of compensation strategies for balance control in patients with spatial neglect

To do so, we will perform a longitudinal cohort study in which we will repetitively assess post-stroke patients using a comprehensive assessment approach for both spatial neglect and motor outcomes. With regards to neglect, we will evaluate various aspects of both visuospatial and personal neglect. For motor outcomes, we will combine clinical and instrumented (biomechanical) assessment methods to evaluate post-stroke recovery of leg paresis, (sitting and standing) balance and gait.

Recruitment: as early as possible after stroke on fixed time-points post-stroke as recommended by the Stroke Recovery and Rehabilitation Roundtable (internationally renowned field experts). We include patients at: ≤14 days, 3 weeks, or 5 weeks post-stroke. Inclusion in RevArte rehabilitation hospital, UZA, GZA St-Augustinus, GZA St-Vincentius and Reva Geel.

Outcome measures: include measures for spatial neglect, motor function and balance/mobility.

Data analysis: linear mixed models will be fitted to evaluate study results and therefore mean change over time.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium
    • Antwerp University Hospital
  • Edegem, Belgium
    • RevArte
  • Wilrijk, Belgium
    • GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

First-ever stroke patients (inpatient or outpatient)

Description

Inclusion Criteria:

• First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
• Age: 18 - 90 years
• Moderate to severe weakness of the lower limb at baseline (MI </=75)
• Pre-morbid independence in activities of daily living (mRS </=2) and gait (FAC >3)
• Able to communicate and comprehend
• Sufficient motivation to participate
• Provided a written informed consent

Exclusion Criteria:

• Other neurological condition affecting motor functions of the lower limbs
• Pre-existing musculoskeletal impairment severely affecting the gait pattern
• Medically unstable
• Non-corrected vision disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rivermead Mobility Index	Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.	Change from <14 days to 3 weeks
Change in Rivermead Mobility Index	Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.	Change from 3 weeks - 5 weeks
Change in Rivermead Mobility Index	Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.	Change from 5 weeks - 8 weeks
Change in Rivermead Mobility Index	Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.	Change from 8 weeks - 12 weeks
Change in Broken Hearts Test	Change in cancellation task for visuospatial neglect	Change from <14 days to 3 weeks
Change in Broken Hearts Test	Change in cancellation task for visuospatial neglect	Change from 3 weeks to 5 weeks
Change in Broken Hearts Test	Change in cancellation task for visuospatial neglect	Change from 5 weeks to 8 weeks
Change in Broken Hearts Test	Change in cancellation task for visuospatial neglect	Change from 8 weeks to 12 weeks
Functional Ambulation Categories	Walking evaluation. Score from 0-5. Higher score means better performance.	Change from <14 days to 3 weeks
Functional Ambulation Categories	Walking evaluation. Score from 0-5. Higher score means better performance.	Change from 3 weeks to 5 weeks
Functional Ambulation Categories	Walking evaluation. Score from 0-5. Higher score means better performance.	Change from 5 weeks to 8 weeks
Functional Ambulation Categories	Walking evaluation. Score from 0-5. Higher score means better performance.	Change from 8 weeks to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk Control Test - item quiet sitting for 30 seconds	Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance.	<14 days, 3 weeks, 5 weeks, 8 weeks, 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.	<14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Motricity index - lower limbs	Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)	<14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Fügl-Meyer Motor Assessment - lower limbs	Selectivity of the paretic lower limb	<14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
5m walk test	Walking speed	<14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Line Bisection Test	Visuospatial neglect test	3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Visuospatial Search Time Test	Visuospatial neglect test	3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Fluff Test	Personal neglect test	3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Tactile extinction test	Personal neglect test	3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Catherine Bergego Scale	ADL related neglect test	3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Postural control; Spatial neglect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Stroke; Perceptual Disorders
• Other Study ID Numbers: D0011000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No