Vision on the Road: Vision Rehabilitation for Driving After Stroke

NCT07147660 | Recruiting

• 2 other identifiers: 781461457711
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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

Conditions

Stroke; Visual Field Loss; Hemianopia

Keywords

Stroke; Vision rehabilitation; Compensatory strategies; Visual field loss; Hemianopia; Loss of drivers license; vision training

Outcome Measures

Primary Outcomes (1)

• Visual Field measured with Saccadic Reaction Time in ms

  Changes/improvements of Saccadic Reaction Time (SRT) measured in milliseconds 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).

Secondary Outcomes (6)

• 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

• 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 Canadian Occupational Performance Measure (COPM)

  Baseline, post-intervention (8 weeks) and 12 weeks post-intervention (20 weeks).

• 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).

• 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).

Study Arms (2)

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.

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.

Other: Delayed Compensatory scanning training

Interventions

Compensatory scanning training OTHER

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

Fast track - Group A

Delayed Compensatory scanning training OTHER

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.

Delayed track - Group B

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South-Eastern Norway: lead
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (2)

University of South-Eastern Norway

Kongsberg, 3616, Norway

RECRUITING

Lovisenberg Diaconal hospital

Oslo, 0440, Norway

RECRUITING

MeSH Terms

Conditions

Stroke; Hemianopsia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helle Falkenberg, Professor

  University of South-Eastern Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marte Rosenvinge, phd-student

CONTACT

+47 31 00 92 05; marte.rosenvinge@usn.no

Helle Falkenberg, Professor

CONTACT

+4731008961; helle.k.falkenberg@usn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 29, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

NO (2)