Clinical trial NCT04072614: Clinical Assessment of Spatial Neglect Following Stroke
Official title: Clinical Assessment and Screening of Patients With Spatial Neglect Following Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Spatial neglect
Perceptual disorders
Diagnostic techniques and procedures
Symptom assessment
Rehabilitation
Acute care
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
Collaborators: name: Lithuanian University of Health Sciences
First posted: 2019-08-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Patients receiving end-of-life care

Primary outcomes:
measure: The Catherine Bergego Scale (CBS)
timeFrame: 1 year post stroke.
measure: Conventional visuo-graphic test: Star cancellation (Index test)
timeFrame: Within 5 days post stroke.
measure: Conventional visuo-graphic test: Figure copying (Index test)
timeFrame: Within 5 days post stroke.
measure: Neglect Experience Qestionnaire (NEQ)
timeFrame: 1 year post stroke
measure: National Institute of HealthStroke Scale (NIHSS) picture description to screen for SN (Index test)
timeFrame: Within 5 days post stroke.
Secondary outcomes:
measure: Stroke severity; National Institute of Health Stroke Scale (NIHSS)
timeFrame: Within 5 days post stroke
measure: Disability and dependency: Barthel Index (BI)
timeFrame: 1 year post stroke
measure: Participation: The modified Rankin Scale (mRS)
timeFrame: Before hospital admission for stroke (recollected),5 days post stroke; three-month poststroke, and 1-year follow up
measure: Patients Reported Ourcome Measures: PROMIS-10
timeFrame: 1 year post stroke
Other outcomes:
measure: Mortality rate
timeFrame: 1 year post stroke
measure: Length of hospital stay
timeFrame: 1 year post stroke
measure: Stroke re-occurence
timeFrame: 1 year post stroke
Locations:
city: Reykjavík
country: Iceland
facility: Landspitali
Study officials:
affiliation: Landspitali
name: Marianne Klinke
role: PRINCIPAL_INVESTIGATOR
References: