Hemianopia, Stroke, Visual Field Loss
Conditions
Keywords
Stroke, Vision rehabilitation, Compensatory strategies, Visual field loss, Hemianopia, Loss of drivers license, vision training
Brief summary
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
Detailed description
AIM: The overall aim is to obtain knowledge about the effects of compensatory visual rehabilitation strategies on functional vision in people with stroke who do not meet the health prerequisites for visual field, as defined in the Driving licences regulations in Norway. Specifically, to describe the effect on functional vision and the compensatory vision strategies related to traffic situations. Secondary, to explore markers for perceived functional vision and functional visual field that may predict an effect of visual rehabilitation. DESIGN: The study will be performed as an open, controlled and randomized trial with semi-cross-over design. The participants will be allocated to an immediate- or delayed intervention following a pre-randomized list. The participants are allocated to immediate intervention (Fast track; Group A) will be investigated at baseline, after 8 and 20 weeks. The remaining participant are allocated to delayed intervention (Delayed start; Group B) will start the intervention 8 weeks after the baseline and investigated at baseline, week 8, week 20 and week 28. SETTING /RECRUITMENT The study sample will consist of adults with post-stroke visual field defects. All the three sub-studies will have the same study sample.
Interventions
OTHERCompensatory scanning training
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.
OTHERDelayed Compensatory scanning training
Delayed 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.
Sponsors
Lovisenberg Diakonale Hospital
University of South-Eastern Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study has a semi-cross over randomisation design. The study will use mixed methods; a qualitative interview study pre- and post-intervention, and an interventional vision rehabilitation study using different quantitative measurements on three or four time points (Baseline, 8 and 20 weeks (Fast track, group A) or Baseline, 8, 16 and 28 weeks (Delayed start, group B). All participants will receive the intervention. Fast track, group A: Fast track participants will receive the intervention immediately after baseline assessments. The intervention are 8 weeks of home-based training exercises for eye movement-, visual scanning-, and visual search exercises to learn compensatory strategies for visual field loss. The investigators will use a licensed online vision training program (Vision Builder) and manual paper-based exercises. Daily vision training will consist of 20 minutes with total minimum recommended training 2h/week for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Motivated and willing to participate in study activities for a total of 20 to 28 weeks * Own a personal computer (for digital follow-up and online vision training) * Able to travel to Oslo for data collection
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Field measured with Saccadic Reaction Time in ms | 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). | Changes/improvements of Saccadic Reaction Time (SRT) measured in milliseconds with BulbiCAM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre/post-intervention changes in quality of life among stroke survivors with visual field defects | Baseline, post-intervention (8 weeks) and long-term effect 12 weeks post-intervention (20-weeks) for both groups. | 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). |
| Pre/post-intervention changes in Canadian Occupational Performance Measure (COPM) | Baseline, post-intervention (8 weeks) and 12 weeks post-intervention (20 weeks). | 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. |
| Pre/post-intervention changes in Reading speed measured with International Reading Speed Text (IReST) | Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups | Measurement of reading speed in words per minute pre/post-intervention using the International Reading Speed Text (IReST). |
| Pre/post-intervention vision function (saccades) tests measured with BulbiCAM | 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). | Changes in saccades measured in latency ms pre/post-intervention measured with BulbiCAM. Two measurements with one hour between tests each time |
| Pre/post-intervention changes in BIVI-IQ score | Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups | The Brain Injury assosiated Visual Impairment Questionnaire (BIVI-IQ) is developed to assess the impact of brain injury associated visual impairment on an individual's vision-related quality of life by 15 questions. Level sum score 0-3 on each question. A higher score indicates greater impact and more difficulty. |
| Pre/post-intervention vision function (fixation stability) tests measured with BulbiCAM | 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). | Changes in vision functions (fixation stability in mm) pre/post-intervention measured with BulbiCAM. Two measurements with one hour between tests each time |
Countries
Norway
Contacts
Primary ContactMarte Rosenvinge, phd-student
Backup ContactHelle Falkenberg, Professor
Outcome results
None listed