Vision on the Road: Vision Rehabilitation for Driving After Stroke

Официальное название

Diagnostics and Rehabilitation of Post-stroke Visual Field Loss Using Innovative Visual Field Evaluation. The Impact of Losing Driving Privileges

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Visual Field measured with Saccadic Reaction Time in ms [Срок оценки: 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).]

Вторичные конечные точки (6)

• Pre/post-intervention changes in Reading speed measured with International Reading Speed Text (IReST) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, post-intervention (8 weeks) and 12 weeks post-intervention (20 weeks).]
• Pre/post-intervention vision function (fixation stability) tests measured with BulbiCAM [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, post-intervention (8 weeks) and long term-effect 12 weeks post-intervention (20 weeks) for both groups]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 2 центра

• University of South-Eastern Norway — Kongsberg
• Lovisenberg Diaconal hospital — Oslo

Идентификаторы

NCT: NCT07147660 · 781461 · 781461 · 457711

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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