An interventional study of Compensatory scanning training and Delayed Compensatory scanning training in Stroke, Visual Field Loss and Hemianopia, sponsored by University of South-Eastern Norway. Recruiting at 2 sites in Norway. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by University of South-Eastern Norway · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 52 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of South-Eastern Norway is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Compensatory scanning training
Delayed track - group B will receive the intervention with a delayed 8 weeks start up. 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.
Other: Delayed Compensatory 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.
Also known as: Vision 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.
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).
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 groups
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.
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).
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).
Pre/post-intervention vision function (saccades) tests measured with BulbiCAM
Changes in saccades measured in latency ms 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).
Pre/post-intervention changes in BIVI-IQ score
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.
Time frame: Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups
Plan to share: Yes — There is a plan to share data that underline results reported in articles after deidentification.
Supporting information: Study protocol
Time frame: Protocol is planned to be published in a peer-reviewed journal in 2025.
Access criteria: Protocol is planned to be published in peer-reviewed journal in 2025 and will be available at the journal site.
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University of South-Eastern Norway