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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Stroke, Spatial Neglect, Postural Control

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Postural control, Spatial neglect