StrokeDRIVENCT07147660
Vision on the Road: Vision Rehabilitation for Driving After Stroke
A study testing Compensatory scanning training and Delayed Compensatory scanning training in people with Stroke and Visual Field Loss, run by University of South-Eastern Norway at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke, Visual Field Loss, Hemianopia
- What is being tested?
- Compensatory scanning training and Delayed Compensatory scanning training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesNorway
- Study dates
- 28 Mar 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
University of South-Eastern Norway
Kongsberg, 3616
Helle K. Falkenberg, Professor, +4731008961, helle.k.falkenberg@usn.no
Marte Rosenvinge, phd-student
- Recruiting
Lovisenberg Diaconal hospital
Oslo, 0440
Anita Tollisen, PhD, +4790238296, anita.tollisen@lds.no
Marte Rosenvinge, phd-student
About this study
Official title: Diagnostics and Rehabilitation of Post-stroke Visual Field Loss Using Innovative Visual Field Evaluation. The Impact of Losing Driving Privileges
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:
Read more
- 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
Read the 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.
- Conditions
- Stroke, Visual Field Loss, Hemianopia
- Being tested
- Compensatory scanning training, Delayed Compensatory scanning training
- Keywords
- Stroke, Vision rehabilitation, Compensatory strategies, Visual field loss, Hemianopia, Loss of drivers license, vision training
- Medical subject headings
- Stroke, Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory scanning trainingOther
Also called Vision 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.
Delayed Compensatory scanning trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fast track - Group A | Experimental | 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. Receives: Other: Compensatory scanning training |
| Delayed track - Group B | Other | 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. Receives: Other: Delayed Compensatory scanning training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Field measured with Saccadic Reaction Time in ms
Changes/improvements of Saccadic Reaction Time (SRT) measured in milliseconds with BulbiCAM
Measured: 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 (6)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start28 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South-Eastern Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Marte Furuheim Rosenvinge, University of South-Eastern Norway
- Investigators
- Helle Falkenberg, Professor, Principal investigator, University of South-Eastern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147660
- Sponsor's protocol ID
- 781461
- Other IDs
- 781461, 457711
- Acronym
- DRIVE
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to share data that underline results reported in articles after deidentification.
Publications
Rosenvinge MF, Lundmark PO, Larsen SE, Eilertsen G, Falkenberg HK. Diagnostics and rehabilitation of post-stroke visual field loss using innovative visual field evaluation. The impact of losing driving privileges (DRIVE-study): Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2026 Jul 21;53:101670. doi: 10.1016/j.conctc.2026.101670. eCollection 2026 Oct.
PubMed 42571232
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics and Rehabilitation of Post-stroke Visual Field Loss Using Innovative Visual Field Evaluation. The Impact of Losing Driving Privileges
- ClinicalTrials.gov ID
- NCT07147660
- Acronym / sponsor ID
- DRIVE / 781461
- Conditions
- Stroke, Visual Field Loss, Hemianopia
- Keywords
- Stroke, Vision rehabilitation, Compensatory strategies, Visual field loss, Hemianopia, Loss of drivers license, vision training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of South-Eastern NorwayUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fast track - Group A | Experimental | Other: Compensatory scanning trainingIndividual 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 track - Group B | Other | Other: Delayed Compensatory scanning trainingDelayed 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compensatory scanning trainingAlso: Vision trainingIndividual 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 | Fast track - Group A |
| Delayed Compensatory scanning trainingDelayed 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. | Other | Delayed track - Group B |
Primary outcome
Visual Field measured with Saccadic Reaction Time in ms
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).
Changes/improvements of Saccadic Reaction Time (SRT) measured in milliseconds with BulbiCAM
6 secondary outcomes
Pre/post-intervention changes in Reading speed measured with 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
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)
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
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
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
Time frame: Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 42571232Rosenvinge MF, Lundmark PO, Larsen SE, Eilertsen G, Falkenberg HK. Diagnostics and rehabilitation of post-stroke visual field loss using innovative visual field evaluation. The impact of losing driving privileges (DRIVE-study): Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2026 Jul 21;53:101670. doi: 10.1016/j.conctc.2026.101670. eCollection 2026 Oct.
- Individual participant dataSharing planned: Yes. There is a plan to share data that underline results reported in articles after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helle Falkenberg, Professor principal investigator
University of South-Eastern Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory scanning training and Delayed Compensatory scanning training in people with Stroke and Visual Field Loss, run by University of South-Eastern Norway at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marte Rosenvinge, phd-student (+47 31 00 92 05, marte.rosenvinge@usn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Field measured with Saccadic Reaction Time in ms (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.