Vision on the Road: Vision Rehabilitation for Driving After Stroke

NCT ID: NCT07147660

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-28

Study Completion Date

2028-02-29

Brief Summary

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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

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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

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Stroke Visual Field Loss Hemianopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fast track - Group A

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.

Group Type EXPERIMENTAL

Compensatory scanning training

Intervention Type 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.

Delayed track - Group B

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.

Group Type OTHER

Delayed Compensatory scanning training

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Delayed 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.

Intervention Type OTHER

Other Intervention Names

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Vision training

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lovisenberg Diakonale Hospital

OTHER

Sponsor Role collaborator

University of South-Eastern Norway

OTHER

Sponsor Role lead

Responsible Party

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Marte Furuheim Rosenvinge

PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle Falkenberg, Professor

Role: PRINCIPAL_INVESTIGATOR

University of South-Eastern Norway

Locations

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University of South-Eastern Norway

Kongsberg, , Norway

Site Status RECRUITING

Lovisenberg Diaconal hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Marte Rosenvinge, phd-student

Role: CONTACT

+47 31 00 92 05

Helle Falkenberg, Professor

Role: CONTACT

+4731008961

Facility Contacts

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Helle K. Falkenberg, Professor

Role: primary

+4731008961

Anita Tollisen, PhD

Role: primary

+4790238296

Other Identifiers

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781461

Identifier Type: REGISTRY

Identifier Source: secondary_id

457711

Identifier Type: REGISTRY

Identifier Source: secondary_id

781461

Identifier Type: -

Identifier Source: org_study_id

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