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临床试验/NCT04651335
NCT04651335Unknown不适用

Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect

Yonsei University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2012年8月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
44
试验地点
1
主要终点
Behavioral Inattention Test (BIT)

研究概览

简要总结

The purpose of this study is to compare and analyze how the visual gaze training in the afferent direction and the visual gaze training in the efferent direction using virtual reality affects the improvement of the neglect phenomenon in patients with subacute stroke with unilateral neglect.

Based on the behavioral intention test (BIT) test and the Mini-Mental Screening Examination test (MMSE) test for the group of unilateral neglected patients with stroke findings among all eligible patients for this experiment.

Appropriate subjects are selected and randomly divided into two groups. One group uses an afferent virtual reality program, and the other uses an efferent virtual reality program to train five times a week for a total of 4 weeks.

Before training, a computer experience scale 21 was additionally performed, and to find out the degree of unilateral negligence, evaluation was performed using the Behavioral Inattention Test (BIT) and Catherine Bergego Scale (CBS)22, and the angle of deflection (deviation angle), out-of-focus time, gaze time, failure rate, and head rotation trajectory were evaluated. In addition, reaction time, failure rate, and head rotation trajectory were evaluated using a virtual reality program (Assessment program-V2) to evaluate the degree of unilateral negligence. After that, BIT, CBS, and Assessment program-V2 tests are performed to determine the degree of improvement in visual ignorance due to each program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A person with left hemiplegia who was found to have a stroke by MRI or CT.
  • •A person who has been confirmed to have unilateral neglect (BIT 196 or less, or each subtest cut off or less)
  • •A person who has enough cognitive ability to receive virtual reality training. (In case of more than 20 points in MMSE)
  • •Those within 3 months of onset.

排除标准

  • •Those with a history of recurring brain damage
  • •hemianopsia
  • •When there is a disorder in the movement of the neck due to orthopedic problems
  • •Someone has vision and hearing problems during evaluation and treatment
  • •difficult to maintain a sitting position in a chair with back and armrests
  • •other diseases that may affect your general cognitive decline
  • •who disagree with this study

研究组 & 干预措施

Concentric

Active Comparator

uses an afferent virtual reality program

干预措施: afferent virtual reality program (Device)

Eccentric

Active Comparator

uses an efferent virtual reality program

干预措施: efferent virtual reality program (Device)

结局指标

主要结局

Behavioral Inattention Test (BIT)

时间窗: 4weeks after end of the treatment

The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.

Behavioral Inattention Test (BIT)

时间窗: before treatment

The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.

Behavioral Inattention Test (BIT)

时间窗: 2weeks

The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.

Behavioral Inattention Test (BIT)

时间窗: 4weeks

The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.

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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