Stroke
Conditions
Keywords
visual field loss, rehabilitation, pilot RCT, process evaluation
Brief summary
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
DEVICENeuroEyeCoach eye movement training
computer based eye movement training for visual field loss in stroke
OTHERUsual Care
Usual post-stroke care
Sponsors
Glasgow Caledonian University
National Health Service, United Kingdom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | through study completion, estimated at 15 months | Rate of recruitment to the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | through study completion, estimated at 15 months | Rate of retention of participants in the study |
| Screening and eligibility rate | Active screening period | Screening and eligibility rate |
| Outcome measure completion rate | over data collection period | through study completion, estimated at 15 months |
| intervention adherence | 6 weeks | adherence to recommended training regime (duration) |
| Adverse events | up to 6 weeks | any adverse eventa experienced |
| Support and computer provision needs | up to 6 weeks | To what extent must technical equipment or assistance be given |
| NEI VFQ 25 (National Eye Institute Visual Function Questionnaire-25) | 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 |
| EQ-5D 5L | 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 |
| IReST (International Reading Speed Test) | baseline, 6 weeks post randomisation, 6 months post randomisation | Reading test (words per minute) |
| Melbourne Rapid Fields | baseline, 6 weeks post randomisation, 6 months post randomisation | visual field test |
| Confidence after Stroke Measure | 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. |
| Warwick-Edinburgh Mental Wellbeing Scale | 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 |
| health care resource use | baseline, 6 weeks post randomisation, 6 months post randomisation | health care resource use, covering general, stroke specific, and vision specific resources |
Contacts
CONTACTChristine Hazelton, PhD
Outcome results
None listed