Vision on the Road: Vision Rehabilitation for Driving After Stroke (DRIVE)

University of South-Eastern Norway

Status: Enrolling

Conditions: Visual Field Loss; Stroke; Hemianopia

Treatments: Other: Compensatory scanning training; Other: Delayed Compensatory scanning training

Study type: Interventional

Funder types: Other

Identifiers

NCT07147660

781461 (Registry Identifier)

457711 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Fast track - Group A

Experimental group

Description:

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.

Treatment:

Other: Compensatory scanning training

Delayed track - Group B

Other group

Description:

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.

Treatment:

Other: Delayed Compensatory scanning training