The Stroke Vision App: A Screening Tool for Visual Stroke
Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors
1 other identifier
interventional
62
1 country
1
Brief Summary
Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision adequately assessed in hospital. An unidentified visual defect can cause significant problems for recovery and quality of life. The Stroke Vision app (an application currently scaled for a 10" Android tablet) has been developed to act as a screening tool for visual problems in stroke survivors; to help identify visual problems earlier and thereby improve rehabilitation outcomes. The app includes a suite of tests for assessing the patient's acuity, their visual fields and to aid in the identification of visual neglect / inattention. Furthermore, it includes educational information on visual stroke in order to better educate staff, patients and their carers. This study seeks to validate the novel digital assessments included in the Stroke Vision app against the current methods used for screening (clinical examination by confrontation field testing). Both screening measures will be compared with the gold standard methods for visual assessments, Octopus perimetry for fields and paper-based methods for visuospatial neglect
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 3, 2015
August 1, 2015
6 months
July 16, 2015
August 31, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with visual field assessment to confrontation in standard clinical practice
Visual field will be captured either by the Stroke Vision App or by confrontation. Visual field will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual field assessment supported by the Stroke Vision App and visual field assessment to confrontation in standard clincial practice will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
All assessments will be conducted following consent at standard clinical assessment visit
Accuracy of Stroke Vision Tablet App to support assessment of visual inattention defects when compared to visual inattention assessment to bilateral stimuli in standard clinical practice
Visual inattention tests will be conducted either by the Stroke Vision App or by inattention to bilateral stimuli in standard clinical practice. Inattention will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual inattention assessment supported by the Stroke Vision App and inattention to bilateral stimuli in standard clincial practice will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
All assessments will be conducted following consent at standard clinical assessment visit
Secondary Outcomes (2)
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessments
All assessments will be conducted following consent at standard clinical assessment visit
Accuracy of Stroke Vision Tablet App to support assessment of visual inattention defects when compared with "Gold standard" Albert's visual inattention test, Star cancellation visual inattention test, Line Bisection test
All assessments will be conducted following consent at standard clinical assessment visit
Other Outcomes (6)
Proportion of patients completing Gold standard vision assessments
All assessments will be conducted following consent at standard clinical assessment visit
Proportion of patients competing usual clinical practice vision assessments
All assessments will be conducted following consent at standard clinical assessment visit
Proportion of patients competing Stroke vision app assessments
All assessments will be conducted following consent at standard clinical assessment visit
- +3 more other outcomes
Study Arms (3)
Gold Standard Assessments
OTHER* Formal perimetry (Goldman or Octopus visual field) * Albert's visual inattention test * Star cancellation visual inattention test * line bisection test * These are performed as part of the routine assessment in the visual stroke orthoptic clinic and neuro-ophthalmology clinics. * The time to perform the assessments or if the participant is unable to complete the assessment will be recorded. * Researcher will record a score (0-10) to quantify the participant's compliance
Usual Clinical Screening Practice
OTHER* Visual field assessment to confrontation * Visual inattention assessment to bilateral stimuli * The time to perform the assessments or if the participant is unable to complete the assessment will be recorded. * Researcher will record a score (0-10) to quantify the participant's compliance
Stroke Vision App
OTHER* Digital tumbling E visual accuity assessment * Digital visual field assessment * Digital line crossing assessment * Digital shape cancellation assessment * The time to perform the assessments or if the participant is unable to complete the assessment will be recorded. * Researcher will record a score (0-10) to quantify the participant's compliance
Interventions
Eligibility Criteria
You may qualify if:
- All patients referred to Visual Stroke Orthoptic Clinics
- All patients with stroke or stroke-like visual problems (for example, but not limited to bitemporal hemianopia caused by pituitary adenoma) referred to the neuro-ophthalmology clinics.
- Consent Provided
You may not qualify if:
- No spoken English
- Unable to provide consent
- Profound cortical blindness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gartnavel General Hospital
Glasgow, Scotland, G12 0YN, United Kingdom
Related Publications (1)
Quinn TJ, Livingstone I, Weir A, Shaw R, Breckenridge A, McAlpine C, Tarbert CM. Accuracy and Feasibility of an Android-Based Digital Assessment Tool for Post Stroke Visual Disorders-The StrokeVision App. Front Neurol. 2018 Mar 28;9:146. doi: 10.3389/fneur.2018.00146. eCollection 2018.
PMID: 29643830DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine McAlpine, MBChB FRCP
NHS Greater Glasgow & Clyde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2015
First Posted
September 3, 2015
Study Start
July 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
September 3, 2015
Record last verified: 2015-08