StrokeNCT05060458
Increasing Insight in Spatial Neglect: Unraveling Its Longitudinal Interaction With Motor Function After Stroke
An observational study of Stroke and Spatial Neglect, run by Universiteit Antwerpen at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Spatial Neglect, Postural Control
- How many people
- 36 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Nov 2019to 11 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First-ever stroke patients (inpatient or outpatient)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Antwerp University Hospital
Edegem
RevArte
Edegem
GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius
Wilrijk
About this study
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.
Read the 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.
- Conditions
- Stroke, Spatial Neglect, Postural Control
- Being tested
- No intervention
- Keywords
- Stroke, Postural control, Spatial neglect
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rivermead Mobility Index
Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from 8 weeks - 12 weeks
Change in Broken Hearts Test
Change in cancellation task for visuospatial neglect
Measured: Change from <14 days to 3 weeks
Change in Broken Hearts Test
Change in cancellation task for visuospatial neglect
Measured: Change from 3 weeks to 5 weeks
Change in Broken Hearts Test
Change in cancellation task for visuospatial neglect
Measured: Change from 5 weeks to 8 weeks
Change in Broken Hearts Test
Change in cancellation task for visuospatial neglect
Measured: Change from 8 weeks to 12 weeks
Functional Ambulation Categories
Walking evaluation. Score from 0-5. Higher score means better performance.
Measured: Change from <14 days to 3 weeks
Functional Ambulation Categories
Walking evaluation. Score from 0-5. Higher score means better performance.
Measured: Change from 3 weeks to 5 weeks
Functional Ambulation Categories
Walking evaluation. Score from 0-5. Higher score means better performance.
Measured: Change from 5 weeks to 8 weeks
Functional Ambulation Categories
Walking evaluation. Score from 0-5. Higher score means better performance.
Measured: Change from 8 weeks to 12 weeks
Secondary outcomes (10)
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.
Measured: <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.
Measured: <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)
Measured: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Fügl-Meyer Motor Assessment - lower limbs
Selectivity of the paretic lower limb
Measured: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
5m walk test
Walking speed
Measured: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Line Bisection Test
Visuospatial neglect test
Measured: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Visuospatial Search Time Test
Visuospatial neglect test
Measured: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Fluff Test
Personal neglect test
Measured: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Tactile extinction test
Personal neglect test
Measured: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Catherine Bergego Scale
ADL related neglect test
Measured: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Nov 2019
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Saeys, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060458
- Sponsor's protocol ID
- D0011000
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Embrechts E, Schroder J, Nijboer TCW, van der Waal C, Lafosse C, Truijen S, Saeys W. Does visuospatial neglect contribute to standing balance within the first 12 weeks post-stroke? A prospective longitudinal cohort study. BMC Neurol. 2024 Jan 22;24(1):37. doi: 10.1186/s12883-023-03475-1.
PubMed 38254026
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Insight in Spatial Neglect: Unraveling Its Longitudinal Interaction With Motor Function After Stroke
- ClinicalTrials.gov ID
- NCT05060458
- Acronym / sponsor ID
- D0011000
- Conditions
- Stroke, Spatial Neglect, Postural Control
- Keywords
- Stroke, Postural control, Spatial neglect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First-ever stroke patients (inpatient or outpatient)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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.
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.
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.
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.
Change in Broken Hearts Test
Time frame: Change from <14 days to 3 weeks
Change in cancellation task for visuospatial neglect
Change in Broken Hearts Test
Time frame: Change from 3 weeks to 5 weeks
Change in cancellation task for visuospatial neglect
Change in Broken Hearts Test
Time frame: Change from 5 weeks to 8 weeks
Change in cancellation task for visuospatial neglect
Change in Broken Hearts Test
Time frame: Change from 8 weeks to 12 weeks
Change in cancellation task for visuospatial neglect
Functional Ambulation Categories
Time frame: Change from <14 days to 3 weeks
Walking evaluation. Score from 0-5. Higher score means better performance.
Functional Ambulation Categories
Time frame: Change from 3 weeks to 5 weeks
Walking evaluation. Score from 0-5. Higher score means better performance.
Functional Ambulation Categories
Time frame: Change from 5 weeks to 8 weeks
Walking evaluation. Score from 0-5. Higher score means better performance.
Functional Ambulation Categories
Time frame: Change from 8 weeks to 12 weeks
Walking evaluation. Score from 0-5. Higher score means better performance.
10 secondary outcomes
Trunk Control Test - item quiet sitting for 30 seconds
Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Berg Balance Scale - item quiet standing for 2 minutes
Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Motricity index - lower limbs
Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Fügl-Meyer Motor Assessment - lower limbs
Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
5m walk test
Time frame: <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Line Bisection Test
Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Visuospatial Search Time Test
Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Fluff Test
Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Tactile extinction test
Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Catherine Bergego Scale
Time frame: 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Derived from this study: PubMed 38254026Embrechts E, Schroder J, Nijboer TCW, van der Waal C, Lafosse C, Truijen S, Saeys W. Does visuospatial neglect contribute to standing balance within the first 12 weeks post-stroke? A prospective longitudinal cohort study. BMC Neurol. 2024 Jan 22;24(1):37. doi: 10.1186/s12883-023-03475-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Spatial Neglect, run by Universiteit Antwerpen at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rivermead Mobility Index (time frame: Change from <14 days to 3 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.