Clinical Assessment and Screening of Patients With Spatial Neglect Following Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Conventional visuo-graphic test: Star cancellation (Index test)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke diagnosis confirmed by results of CT/MRI.
- •Lives in Iceland or Lithuania.
- •18 year or older.
- •Informed consent provided by patient or proxy.
排除标准
- •Patients receiving end-of-life care
结局指标
主要结局
Conventional visuo-graphic test: Star cancellation (Index test)
时间窗: Within 5 days post stroke.
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.
Neglect Experience Qestionnaire (NEQ)
时间窗: 1 year post stroke
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.
National Institute of HealthStroke Scale (NIHSS) picture description to screen for SN (Index test)
时间窗: Within 5 days post stroke.
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.
The Catherine Bergego Scale (CBS)
时间窗: 1 year post stroke.
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.
Conventional visuo-graphic test: Figure copying (Index test)
时间窗: Within 5 days post stroke.
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.
次要结局
- Stroke severity; National Institute of Health Stroke Scale (NIHSS)(Within 5 days post stroke)
- Disability and dependency: Barthel Index (BI)(1 year post stroke)
- Patients Reported Ourcome Measures: PROMIS-10(1 year post stroke)
- Participation: The modified Rankin Scale (mRS)(Before hospital admission for stroke (recollected),5 days post stroke; three-month poststroke, and 1-year follow up)
研究者
Marianne Elisabeth Klinke
Associate Professor and Academic Chair of Nursing Care and Research within Neurology
Landspitali University Hospital