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Pilot RCT of Computer-based Eye Movement Training (CRYSTAL)

2026年8月3日 更新者：Glasgow Caledonian University

Computer-based Eye Movement Training for Stroke-related Visual Field Loss: a Pilot Randomised Controlled Trial

The goal of this study is to learn whether NeuroEyeCoach, a computer-based eye movement training programme, can help stroke survivors with visual field loss. The study will also assess whether a larger clinical trial is feasible. The main questions it aims to answer are:

  • Can stroke survivors be successfully recruited, randomised and followed up in a larger trial?
  • Is NeuroEyeCoach acceptable and practical to use?
  • Is there early evidence that NeuroEyeCoach improves vision-related functioning and wellbeing? Researchers will compare NeuroEyeCoach plus usual care with usual care alone.

Participants will:

  • Be randomly assigned to receive NeuroEyeCoach plus usual care or usual care alone
  • Complete six weeks of training if allocated to NeuroEyeCoach
  • Complete questionnaires and tests of vision, daily activities, quality of life, confidence and wellbeing
  • Take part in follow-up assessments over six months This pilot trial will include 60 stroke survivors living with visual field loss after stroke. Findings will be used to inform the design of a larger study.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • adult (>18 years)
  • stroke survivor
  • stroke-related homonymous VFL (minimum quadrantanopia)
  • sufficient language, cognitive, and upper limb ability to participate in trial activities.

Exclusion Criteria:

  • pre-existing (ie pre-stroke) registration as sight impaired (partially sighted) or severely sight impaired (blind)
  • • history of seizure disorders, especially those of a photosensitive nature

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Eye movement training + usual care
Usual post-stroke care, plus eye movement training (VISIOcoach)
设备：NeuroEyeCoach eye movement training
computer based eye movement training for visual field loss in stroke
其他：Usual Care
Usual post-stroke care
其他：usual care
Usual post-stroke care
其他：Usual Care
Usual post-stroke care

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Recruitment rate
大体时间：through study completion, estimated at 15 months
Rate of recruitment to the trial
through study completion, estimated at 15 months

次要结果测量

结果测量
措施说明
大体时间
Retention Rate
大体时间：through study completion, estimated at 15 months
Rate of retention of participants in the study
through study completion, estimated at 15 months
Screening and eligibility rate
大体时间：Active screening period
Screening and eligibility rate
Active screening period
Outcome measure completion rate
大体时间：over data collection period
through study completion, estimated at 15 months
over data collection period
intervention adherence
大体时间：6 weeks
adherence to recommended training regime (duration)
6 weeks
Adverse events
大体时间：up to 6 weeks
any adverse eventa experienced
up to 6 weeks
Support and computer provision needs
大体时间：up to 6 weeks
To what extent must technical equipment or assistance be given
up to 6 weeks
NEI VFQ 25 (National Eye Institute Visual Function Questionnaire-25)
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
Patient-reported measure of vision-related functioning. Minimum value is 0, and maximum value is 100; higher scores mean a better outcome
baseline, 6 weeks post randomisation, 6 months post randomisation
EQ-5D 5L
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
Generic health related quality of life Maximum value 1.0; better scores mean a better outcome
baseline, 6 weeks post randomisation, 6 months post randomisation
IReST (International Reading Speed Test)
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
Reading test (words per minute)
baseline, 6 weeks post randomisation, 6 months post randomisation
Melbourne Rapid Fields
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
visual field test
baseline, 6 weeks post randomisation, 6 months post randomisation
Confidence after Stroke Measure
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
Validated questionnaire that explores self-confidence, positive attitude and social confidence Minimum score is 0 and the maximum score is 81; a higher score indicates better outcome Ref: Horne JC, Lincoln NB, Logan PA. Measurement of confidence: the development and psychometric evaluation of a stroke-specific, measure of confidence. Clin Rehabil. 2017 Nov;31(11):1529-1537. doi: 10.1177/0269215517705424. Epub 2017 May 3. PMID: 28466669; PMCID: PMC5652651.
baseline, 6 weeks post randomisation, 6 months post randomisation
Warwick-Edinburgh Mental Wellbeing Scale
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
Mental wellbeing questionnaire Minimum raw score is 7 and the maximum raw score is 35; higher score means a better outcome
baseline, 6 weeks post randomisation, 6 months post randomisation
health care resource use
大体时间：baseline, 6 weeks post randomisation, 6 months post randomisation
health care resource use, covering general, stroke specific, and vision specific resources
baseline, 6 weeks post randomisation, 6 months post randomisation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Glasgow Caledonian University

合作者

National Health Service, United Kingdom

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2025年12月3日

首先提交符合 QC 标准的

2026年8月3日

首次发布 (实际的)

2026年8月7日

研究记录更新

最后更新发布 (实际的)

2026年8月7日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HLS/LS/25/032
  • TCS/24/40 (其他赠款/资助编号：Chief Scientist Office Scotland)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

We have not yet discussed and decided our IPD sharing position

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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