Vision on the Road: Vision Rehabilitation for Driving After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorUniversity of South-Eastern Norway
About this trial
The goal of this clinical trial is to learn if vision training works to improve functional vision in people with visual field loss after stroke. The investigators want to know more about how people perceive their own functional vision and ability to compensate for visual field loss in daily activities.
The main questions the study aims to answer are:
* Does vision training improve dimensions of functional vision? * How does vision training affect the participants's perception of functional vision and the ability to compensate for visual field loss? Researchers will compare the effect of home-based vision training to standard care (no vision training) on functional vision.
Participants will:
* Participate in home-based vision training or standard care for 8 weeks * Be contacted once a week by phone * Keep a training diary
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 20-85 years with a visual field defect following stroke
Norwegian Class 1 driving licence revoked no more than five years ago
Speak a Scandinavian language
Able to provide written informed consent
Disqualifiers
Presence of strabismus and/or visual neglect
Eye disease or other health conditions that do not meet the health requirements for a Norwegian Class 1 driver's license
Cognitive impairment, dementia, severe psychiatric diagnosis, or inability to provide written informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Compensatory scanning training
Other interventionIndividual home-based vision training exercises for 20 minutes every day for 8 weeks. A training program with online and manual oculomotor exercises, scanning and visual search-exercises. Weekly short follow up-conversation by telephone to check in and keep the motivation high with the participants.
Delayed Compensatory scanning training
Other interventionDelayed track start. Individual home-based vision training exercises for 20 minutes every day for 8 weeks. A training program with online and manual oculomotor exercises, scanning and visual search-exercises. Weekly short follow up-conversation by telephone to check in and keep the motivation high with the participants.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Fast track - Group AExperimental treatment 1 intervention
Group B: Delayed track - Group BOther 1 intervention
Trial outcomes
Primary outcomes
1
Visual Field measured with Saccadic Reaction Time in ms
Changes/improvements of Saccadic Reaction Time (SRT) measured in milliseconds with BulbiCAM
Time frame
Two measurements (1 hour between assessments) at baseline, post-intervention (8 weeks) (post-intervention group A, post-control/pre-intervention group B) and a final measurement (long-term effect) 12 weeks after intervention (20 weeks after baseline).Secondary outcomes
1
Pre/post-intervention changes in Reading speed measured with International Reading Speed Text (IReST)
Measurement of reading speed in words per minute pre/post-intervention using the International Reading Speed Text (IReST).
Time frame
Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups2
Pre/post-intervention changes in quality of life among stroke survivors with visual field defects
Pre-/post-intervention changes in self-reported Euroqol -item QoL scale (EQ5D). The EQ-5D-5L includes five dimensions with a level score from 1 (= no problems) to 5 (= Extreme problems / Unable to perform) resulting in a 5-digit health state, which describes their current health. Another scoring option is to report a utility score (index value) where the health state is converted into a country-specific value set range from 1.000 (perfect health) to 0.000 (death). Results may also be presented as level sum score across all five dimensions with minimum score: 5 (best health: 11111), maximum score: 25 (worst health: 55555). Higher scores indicate worse health. The VAS scale rate overall health on a scale from 0 (worst imaginable) to 100 (best imaginable).
Time frame
Baseline, post-intervention (8 weeks) and long-term effect 12 weeks post-intervention (20-weeks) for both groups.3
Pre/post-intervention changes in Canadian Occupational Performance Measure (COPM)
The COPM is used to identify up to five self-perceived problems related to activity performance. It assesses both performance and satisfaction with performance across these activities. Scoring is based on two scales: Performance score: ranges from 1 to 10, where a higher score indicates better performance. Satisfaction score: ranges from 1 to 10, where a higher score indicates greater satisfaction with performance.Total performance score: sum of scores across all identified activities (range: 1-50). Total satisfaction score: sum of satisfaction ratings across all identified activities (range: 1-50). Mean scores: dividing the total score by the number of activities rated. Changes in both mean performance and mean satisfaction scores from baseline to follow-up are used to evaluate the impact of the intervention.
Time frame
Baseline, post-intervention (8 weeks) and 12 weeks post-intervention (20 weeks).4
Pre/post-intervention vision function (fixation stability) tests measured with BulbiCAM
Changes in vision functions (fixation stability in mm) pre/post-intervention measured with BulbiCAM. Two measurements with one hour between tests each time
Time frame
Two measurements (1 hour between assessments) at baseline, post-intervention (8 weeks) (post-intervention group A, post-control/pre-intervention group B) and a final measurement (long-term effect) 12 weeks after intervention (20 weeks after baseline).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South-Eastern Norway
Lead sponsor
Lovisenberg Diakonale Hospital
Collaborator
Source ClinicalTrials.gov