NCT07752563尚未招募不适用
Computer-based Eye Movement Training for Stroke-related Visual Field Loss: a Pilot Randomised Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •adult (>18 years)
- •stroke survivor
- •stroke-related homonymous VFL (minimum quadrantanopia)
- •sufficient language, cognitive, and upper limb ability to participate in trial activities.
排除标准
- •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
研究组 & 干预措施
Eye movement training + usual care
Experimental
Usual post-stroke care, plus eye movement training (VISIOcoach)
干预措施: NeuroEyeCoach eye movement training (Device)
Eye movement training + usual care
Experimental
Usual post-stroke care, plus eye movement training (VISIOcoach)
干预措施: Usual Care (Other)
usual care
Other
Usual post-stroke care
干预措施: Usual Care (Other)
结局指标
主要结局
Recruitment rate
时间窗: through study completion, estimated at 15 months
Rate of recruitment to the trial
次要结局
- Retention Rate(through study completion, estimated at 15 months)
- Screening and eligibility rate(Active screening period)
- Outcome measure completion rate(over data collection period)
- intervention adherence(6 weeks)
- Adverse events(up to 6 weeks)
- Support and computer provision needs(up to 6 weeks)
- NEI VFQ 25 (National Eye Institute Visual Function Questionnaire-25)(baseline, 6 weeks post randomisation, 6 months post randomisation)
- EQ-5D 5L(baseline, 6 weeks post randomisation, 6 months post randomisation)
- IReST (International Reading Speed Test)(baseline, 6 weeks post randomisation, 6 months post randomisation)
- Melbourne Rapid Fields(baseline, 6 weeks post randomisation, 6 months post randomisation)
- Confidence after Stroke Measure(baseline, 6 weeks post randomisation, 6 months post randomisation)
- Warwick-Edinburgh Mental Wellbeing Scale(baseline, 6 weeks post randomisation, 6 months post randomisation)
- health care resource use(baseline, 6 weeks post randomisation, 6 months post randomisation)
研究者
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