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StrokeNCT04072614

Clinical Assessment of Spatial Neglect Following Stroke

An observational study of Stroke, run by Landspitali University Hospital at 1 site in Iceland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Spatial neglect (SN) is a common heterogeneous cognitive affliction that predicts poor recovery after a stroke. It is important to identify SN so alliviating actions can be initated. Results of this cross-country study between Iceland and Lithuania should provide information on how to best identify SN in clinical care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
How many people
1,000 participants
Where
1 siteIceland
Study dates
15 Dec 2019to Dec 2025
How long will I take part?
12 Months
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Ethical approval has been obtained to conduct the data collection within the National University Hospital in Iceland (LUHI) and Hospital of Lithuanian University of Health Sciences, Kauno klinikos (LSMU-KK). Consecutive stroke patients will be assessed until we have included at least 1000 stroke patients where minimum 200 patients have SN. The yearly admissions for the years 2017 and 2018 have been an average of 850 patients (250 NUHI; LSMU-KK; 600). By anticipating lack of data in 30% instances, the required number of patients should be possible to enroll withhin 1 ½ - 2 years. Stroke patients without SN are required for evaluating the psychometric properties of SN tests and to enable comparison of clinical characteristics between patients with and without SN.

Who may be able to join

  • Stroke diagnosis confirmed by results of CT/MRI.
  • Lives in Iceland or Lithuania.
  • 18 year or older.
  • Informed consent provided by patient or proxy.

Who cannot join

  • Patients receiving end-of-life care

Trial locations and contacts

1 site in 1 country.

Marianne Klinke contact

+354 5254000

marianne@hi.is

Halla Arnardottir contact

hallarn@landspitali.is

Iceland1 site, 1 recruiting

  • Landspitali

    Reykjavik

    Marianne Klinke

    Recruiting

Other trials in Iceland

About this study

Official title: Clinical Assessment and Screening of Patients With Spatial Neglect Following Stroke

Spatial neglect (SN) is a common heterogeneous cognitive affliction that predicts poor recovery after a stroke. It is important to identify SN so alliviating actions can be initated. Results of this cross-country study between Iceland and Lithuania should provide information on how to best identify SN in clinical care.

Read the detailed description

Spatial neglect (SN) is a common disorder following stroke, adversely affecting recovery. SN often involves associated symptoms, including anosognosia, extinction, difficulties with sustained attention and problems with emotional processing. Correct identification of SN and associated problems is essential for initiating alleviating strategies and for measuring progress. Several assessment tools exist, but psychometric testing has mostly been conducted in non-dynamic environments; a single country or culture. Thus non-transferable to a wider context and ward-based care. To optimize identification of SN and develop procedures for diverse healthcare settings, this cross-country study includes patients from Iceland and Lithuania. We will seek to maximize the clinical utility by avoiding exclusion of patients, e.g., with psycholinguistic difficulties and multiple strokes. We will: a) use behavioral SN assessment and visuo-graphic tests to validate a newly developed SN tool that incorporates many aspects of SN that are currently not addressed in conventional tests, b) validate integration of an additional component into the National Institute of Health Stroke Scale as a screening tool to identify SN, and c) evaluate differences in clinical characteristics between patients with left- and right-sided SN, and patients with and without SN.

Conditions
Stroke
Keywords
Spatial neglect, Perceptual disorders, Diagnostic techniques and procedures, Symptom assessment, Rehabilitation, Acute care
Medical subject headings
Stroke, Perceptual Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Catherine Bergego Scale (CBS)

    The Catherine Bergego Scale (CBS) reveals presence, severity and common challenges of SN. The ten items of the scale gauge; topographical orienting; navigation, underuse of hand/arm; difficulties with dressing and grooming; difficulties attending to auditory stimuli; collisions, and searching for, or identifying objects on the neglected side. Each item will be graded from zero to three. A total score of 1-10 indicates mild SN, 11-20 moderate SN and 21-30 severe SN. The CBS will be used as a clinical reference standard for SN and to evaluate change over time. Patients with SN within 5 days post stroke will be assessed with a modified version of the CBS at three months post stroke and 1-year follow up.

    Measured: 1 year post stroke.

  2. Conventional visuo-graphic test: Star cancellation (Index test)

    Identifying small stars among a variety of distractors (short words and big stars). Maximun score 54, cut of point for SN 51 or less cancellations of small stars or a lateralized difference of at least two stars between two calculations.

    Qualitative evaluation of starting point.

    Measured: Within 5 days post stroke.

  3. Conventional visuo-graphic test: Figure copying (Index test)

    Replication of a four-item drawing: a tree, a house, a fence, and a car. Scoring based on completion and location of drawings. A maximum score of eight corresponds to 100% failure. Any omissions of left-sided (or right-sided) features scored one. Inability to reproduce an entire figure scored as two, and drawing the left (right) side of the figure on the right (left) side of the paper was awarded with one. A score of > 1 (or 12,5%) is confirmative for neglect.

    Qualitative evaluation of starting point.

    Measured: Within 5 days post stroke.

  4. Neglect Experience Qestionnaire (NEQ)

    9 item Neglect Assessment Tool (NEQ). The NEQ has been developed based on observation and interviews of 70 patients with SN and now comprises nine questions/ observations reflecting of abnormal bodily experiences associated with SN. Required observations will be collected during daily activities and combined with an approximate 5-minute interview. The NEQ will be used in the following ways: As a clinical reference standard, as an index test, and to measure change over time. Patients with SN within 5 days post stroke will be assessed with a modified version of the NEQ at three months post stroke and 1 year post stroke.

    Measured: 1 year post stroke

  5. National Institute of HealthStroke Scale (NIHSS) picture description to screen for SN (Index test)

    The drawing used to assess for aphasia within the NIHSS will be used to screen for SN. Patients will be scored according to their ability to describe items within the picture. We will for instance evaluate ability to describe items within the contralesional and ipsilesional side of the A4 paper-sheet when the paper is aligned first to the midsaggital body plane.

    Measured: Within 5 days post stroke.

Secondary outcomes (4)

  1. Stroke severity; National Institute of Health Stroke Scale (NIHSS)

    Comprising 11 items; impaired consciousness, horizontal eye movement, visual fields (hemianopia); facial paralysis; motor strength (arms/legs), ataxia, aphasia, dysarthria, and extinction will be used. Hemianopia will be evaluated while patients have both renotopic fields within the intact hemispace. The score ranges from 0-42; a score of 0 indicated "no signs of stroke" and higher score designates increased severity. 0=No stroke symptoms, 1-4=Minor stroke, 5-15=Moderate stroke, 15-20=Moderate/severe stroke, 21-42=Severe stroke.

    Measured: Within 5 days post stroke

  2. Disability and dependency: Barthel Index (BI)

    The BI will be used to evaluate change in disability and dependence over time and differences between patients with and without SN. Measurement will be completed within 5 days post stroke; three-month post stroke, and at 1-year follow up.

    basic activities. The score ranges from 0-100 with 5-point increments. A score of 0 denotes total dependence.

    Measured: 1 year post stroke

  3. Participation: The modified Rankin Scale (mRS)

    The modified Rankin Scale (mRS) provides a score from total independence/perfect health to death/no function (0-6).

    Measured: Before hospital admission for stroke (recollected),5 days post stroke; three-month poststroke, and 1-year follow up

  4. Patients Reported Ourcome Measures: PROMIS-10

    PROMIS-10 provide information about perceived domains of health including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Questions posed by the researcher within each of the 10 global health domains are scored by examine each item separately and score on a Likert-like scale to allow identification of specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health.

    Measured: 1 year post stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start15 Dec 2019
  3. Primary completionSep 2022 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
1,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04072614
Sponsor's protocol ID
LSH-19-002
Status last verified
May 2020
First submitted
20 Aug 2019
Last updated
18 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Landspitali University Hospital at 1 site in Iceland.

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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iceland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marianne Klinke (+354 5254000, marianne@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Catherine Bergego Scale (CBS) (time frame: 1 year post stroke.). The study lists 5 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 NCT04072614.

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 18 May 2020.

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