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

INTRODUCTION: The overall aim is to explore the impact of losing driving privileges and to estimate the effect of compensatory vision rehabilitation in Norwegian stroke survivors whose driver's licenses have been revoked due to VFL. Specifically, to evaluate the effect of vision rehabilitation on perceived and measured functional vision, and secondarily explore markers for perceived functional vision and functional visual field that may predict an effect of vision rehabilitation. METHODS: This study is an open, randomized controlled trial (RCT) with delayed-start design. Stroke survivors aged 20-85 years (N = 52) will be recruited from a vision rehabilitation clinic in Norway and randomized into two arms: A) immediate start of eight-week home-based vision rehabilitation intervention and B) delayed start (eight weeks) of the same eight-week vision rehabilitation intervention. A quantitative and qualitative approach will be applied to assess changes in functional vision after eight weeks of vision rehabilitation, and at twelve weeks post-intervention in both groups. The quantitative analysis includes descriptive statistics, plots and inferential statistics of effects. In addition, ten participants will be recruited for qualitative individual interviews before and after the eight-week intervention to explore experiences of living with VFL and participating in the intervention. For the qualitative analysis, we will apply thematic analysis. CONCLUSIONS: The study is designed as an RCT that will give important insight into the effectiveness of vision rehabilitation for visual field loss after stroke on functional vision measured by a novel VR-vision test. TRIAL REGISTRATION: ClinicalTrials.gov: NCT07147660.