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Completed

NCT Number: NCT05060458

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Change in Rivermead Mobility Index

    Time frame: Change from <14 days to 3 weeks

    Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  2. Change in Rivermead Mobility Index

    Time frame: Change from 3 weeks - 5 weeks

    Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  3. Change in Rivermead Mobility Index

    Time frame: Change from 5 weeks - 8 weeks

    Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  4. Change in Rivermead Mobility Index

    Time frame: Change from 8 weeks - 12 weeks

    Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  5. Change in Broken Hearts Test

    Time frame: Change from <14 days to 3 weeks

    Change in cancellation task for visuospatial neglect

  6. Change in Broken Hearts Test

    Time frame: Change from 3 weeks to 5 weeks

    Change in cancellation task for visuospatial neglect

  7. Change in Broken Hearts Test

    Time frame: Change from 5 weeks to 8 weeks

    Change in cancellation task for visuospatial neglect

  8. Change in Broken Hearts Test

    Time frame: Change from 8 weeks to 12 weeks

    Change in cancellation task for visuospatial neglect

  9. Functional Ambulation Categories

    Time frame: Change from <14 days to 3 weeks

    Walking evaluation. Score from 0-5. Higher score means better performance.

  10. Functional Ambulation Categories

    Time frame: Change from 3 weeks to 5 weeks

    Walking evaluation. Score from 0-5. Higher score means better performance.

  11. Functional Ambulation Categories

    Time frame: Change from 5 weeks to 8 weeks

    Walking evaluation. Score from 0-5. Higher score means better performance.

  12. Functional Ambulation Categories

    Time frame: Change from 8 weeks to 12 weeks

    Walking evaluation. Score from 0-5. Higher score means better performance.

Secondary outcomes

  1. Trunk Control Test - item quiet sitting for 30 seconds

    Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance.

  2. Berg Balance Scale - item quiet standing for 2 minutes

    Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Ability to stand unsupported. Score from 0 to 4. Higher score means better performance.

  3. Motricity index - lower limbs

    Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)

  4. Fügl-Meyer Motor Assessment - lower limbs

    Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Selectivity of the paretic lower limb

  5. 5m walk test

    Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Walking speed

  6. Line Bisection Test

    Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Visuospatial neglect test

  7. Visuospatial Search Time Test

    Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Visuospatial neglect test

  8. Fluff Test

    Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Personal neglect test

  9. Tactile extinction test

    Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    Personal neglect test

  10. Catherine Bergego Scale

    Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

    ADL related neglect test

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2021
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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