Pilot RCT of Computer-based Eye Movement Training

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlasgow Caledonian University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult (>18 years)

stroke survivor

stroke-related homonymous VFL (minimum quadrantanopia)

sufficient language, cognitive, and upper limb ability to participate in trial activities.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NeuroEyeCoach eye movement training

    Device

    computer based eye movement training for visual field loss in stroke

  • Usual Care

    Other intervention

    Usual post-stroke care

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Eye movement training + usual careExperimental treatment 2 interventions
Group B: usual careOther 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

Rate of recruitment to the trial

Time frame
through study completion, estimated at 15 months

Secondary outcomes

1

Retention Rate

Rate of retention of participants in the study

Time frame
through study completion, estimated at 15 months
2

Screening and eligibility rate

Screening and eligibility rate

Time frame
Active screening period
3

Outcome measure completion rate

through study completion, estimated at 15 months

Time frame
over data collection period
4

intervention adherence

adherence to recommended training regime (duration)

Time frame
6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glasgow Caledonian University

Lead sponsor

National Health Service, United Kingdom

Collaborator

This trial is not recruiting at the moment. You can still explore other options: