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临床试验/NCT06301815
NCT06301815已完成不适用

Identifying Vertical Perception Loss in People With Acute Stroke: A Feasibility Study

University of Winchester1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Bucket Test to Measure Subjective Visual Vertical (SVV).

研究概览

简要总结

The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is:

• To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss.

Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments.

If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting.

详细描述

The secondary research questions that this study will aim to address are:

  • What percentage of patients admitted to an acute stroke unit show a positive test for vertical perception loss within four weeks of admission (evidence of subjective visual vertical (SVV) tilt on either bucket test or Catherine Bergego Scale or evidence of subjective postural vertical (SPV) tilt on SCP)?

  • For those able to complete the assessments, does vertical perception loss show any relationship with:

  • Discharge (DC) destination

  • Care package size on discharge

  • Number of inpatient falls

  • Level of functional independence on discharge

  • Is there a trend for any element of the SCP or the Catherine Bergego to be more correlated with SVV tilt.

Primary outcomes:

The primary outcome is to understand the feasibility of completing the suite of outcome measures in an acute stroke setting. The study will determine the :

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of first stroke by stroke consultant based on clinical or radiographical findings
  • Admitted to stroke unit with a length of stay of over 72 hours
  • Ability to consent or an advocate to consent on their behalf
  • Pre-morbid Modified Rankin Scale of less than 4

排除标准

  • Under the age of 18
  • Diagnosis of Transient Ischaemic Attack (TIA)
  • Previous diagnosis of stroke or other neurological diagnosis affecting the brain with residual impairment
  • Patients on an end of life pathway
  • Patients with pre-morbid visual impairment that will not allow them to see the bucket test. Glasses can be worn.
  • Inability to speak the English language and no interpreter can be found

结局指标

主要结局

Bucket Test to Measure Subjective Visual Vertical (SVV).

时间窗: Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.

The bucket test involves the patient being sat upright and looking into a translucent bucket. On the inside of the bucket on the bottom is a dark straight line. On the outside of the bottom of the bucket is a matching dark line, the bottom of the bucket is divided into degrees with the zero-degree line being equivalent to the line inside the bucket. For measurement the bucket will be randomly rotated right or left by the examiner to 45 degrees and then slowly rotated back to the zero-degree position. Patients will signal when they estimate the inside bottom line to be truly vertical by saying "stop" or by raising their non-paretic hand. Degrees will be read off on the outside scale by the examiner. The procedure will be repeated 6 times (3 to left and 3 to right) in a random order. A mean of the 6 tests will be calculated to be the tilt of SVV. The standard deviation (SD) of the mean of the 6 tests will be calculated to represent the uncertainty of SVV.

Catherine Bergego Scale to Measure Neglect.

时间窗: Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.

Neglect will be assessed using the Catherine Bergego Scale. This established outcome measure for neglect is free and observational, it reflects existing practice and therefore reduces the burden on research participants. The scale is a 10-point scale with each item scored between 0 (no neglect) and 3 (severe neglect). Such as grooming, walking, eating and dressing. Minimum score is 0 - no neglect and maximum score is 30 - severe neglect

Scale for Contraversive Pushing to Measure Lateropulsion

时间窗: Admission, 1 week, 2 weeks and 4 weeks, but not repeated once succesfully completed.

Lateropulsion will be assessed using the Scale for Contraversive Pushing (SCP). This observational assessment can be conducted as part of routine therapy sessions. Scores are assessed in sitting and standing giving a maximum score of 6. The SCP has been found to be a reliable and valid measure. It involves observation of the posture of the patient in sitting and standing. Minimum score of 0 is no sign of lateropulsion and maximum score of 6 is severe lateropulsion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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