An observational study in Stroke, sponsored by Landspitali University Hospital. Recruiting at 1 site in Iceland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Landspitali University Hospital · Observational
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Landspitali University Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 1 year post stroke.
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.
Time frame: Within 5 days post stroke.
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.
Time frame: Within 5 days post stroke.
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.
Time frame: 1 year post stroke
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.
Time frame: Within 5 days post stroke.
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.
Time frame: Within 5 days post stroke
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.
Time frame: 1 year post stroke
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).
Time frame: Before hospital admission for stroke (recollected),5 days post stroke; three-month poststroke, and 1-year follow up
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.
Time frame: 1 year post stroke
Mortality rate
Mortality rate within the first year
Time frame: 1 year post stroke
Length of hospital stay
Length of hospital stay in days
Time frame: 1 year post stroke
Stroke re-occurence
Number of stroke events within the first year
Time frame: 1 year post stroke
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2019 (actual). Primary completion is estimated for Sep 2022, 33 months after the start.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 33 months is below that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
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Landspitali University Hospital