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Not yet recruiting NCT07752563

Pilot RCT of Computer-based Eye Movement Training

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NeuroEyeCoach eye movement training, Usual Care.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device NeuroEyeCoach eye movement training
    computer based eye movement training for visual field loss in stroke
  • Other Usual Care
    Usual post-stroke care

Primary outcome measures

  • Recruitment rate [Time frame: through study completion, estimated at 15 months]
Secondary outcome measures (12)
  • Retention Rate [Time frame: through study completion, estimated at 15 months]
  • Screening and eligibility rate [Time frame: Active screening period]
  • Outcome measure completion rate [Time frame: over data collection period]
  • intervention adherence [Time frame: 6 weeks]
  • Adverse events [Time frame: up to 6 weeks]
  • Support and computer provision needs [Time frame: up to 6 weeks]
  • NEI VFQ 25 (National Eye Institute Visual Function Questionnaire-25) [Time frame: baseline, 6 weeks post randomisation, 6 months post randomisation]
  • EQ-5D 5L [Time frame: baseline, 6 weeks post randomisation, 6 months post randomisation]
  • IReST (International Reading Speed Test) [Time frame: baseline, 6 weeks post randomisation, 6 months post randomisation]
  • Melbourne Rapid Fields [Time frame: baseline, 6 weeks post randomisation, 6 months post randomisation]
  • Confidence after Stroke Measure [Time frame: baseline, 6 weeks post randomisation, 6 months post randomisation]
  • Warwick-Edinburgh Mental Wellbeing Scale [Time frame: baseline, 6 weeks post randomisation, 6 months post randomisation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07752563 · HLS/LS/25/032 · TCS/24/40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗