About this trial
In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people after stroke. Vision is the most important sense in humans, and even smaller permanent injuries can drastically reduce quality of life.
Vision impairments after brain damage inhibits rehabilitation and enhances other invalidating effects. Reduced vision results in impaired balance, increased risk of serious falls, increased support needs, reduced quality of life, and impaired ability to perform activities of daily living. Restoration of visual field impairments occur only to a small extent during the first month after brain damage, and therefore the time window for spontaneous improvements is very limited. Hence, brain-impaired persons with visual impairment will most likely experience chronically impaired vision already 4 weeks after brain injury and the need for visual compensatory rehabilitation is substantial.
Neuro Vision Technology (NVT) is an supervised training course where people with visual impairments are trained in compensatory techniques using special equipment. Through the NVT process, the individual's vision problems are carefully investigated and personal data is used to organize individual training sessions that practice the individual in coping with situations that cause problems in everyday life.
The purpose of this study is to investigate whether rehabilitation with NVT can cause significant and lasting improvement in functional capacity in persons with chronic visual impairments after brain injury. Improving eyesight is expected to increase both physical and mental functioning, thus improving the quality of life. Participants included in the project will be investigated in terms of both visual and mental functions, including quality of life, cognition and depression. Such an investigation has not been performed previously and can have a significant impact on vision rehabilitation both nationally and internationally.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
14 years or older with brain injury.
Persons who experience significant vision impairment.
Eye sight 6/18 or better.
The time from symptoms onset to study inclusion is between 6 weeks and 9 months.
Disqualifiers
Cognitive dysfunction.
Persons with anosognosia or severe neglect.
Inability to move independently at least 35 meters with or without assistance, including wheelchairs.
Inability to understand Danish or with communication disorders that prevent participation in tests.
Trial design
Parallel
Treatments tested in this trial
Neuro Vision Technology
DeviceTraining using Neuro Vision Technology
Treatment groups
Trial outcomes
Primary outcomes
Ability to complete a mobility route
Target identification and thus to compare how many targets are seen after the intervention.
Secondary outcomes
Time to complete a mobility route
Time consumption and thus speed to complete the mobility route. Through the route there are a number of targets (stars) that study participants should try to locate. Investigators measure the time spent by study participants on the route, as well as the number of targets ignored by any participant. Measured in minutes and seconds.
National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
Questionnaire dealing with vision problems and concerns associated with a person's visual function. Measured in points summing up several scales.
Short Form (36) Health Survey (SF-36)
Assessment of quality of life. Measured in points summing up several scales.
Montreal Cognitive Assessment (MoCA)
Cognitive screening test that provides an estimate of the intellectual functional level.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Gentofte, Copenhagen
Lead sponsor
Copenhagen University Hospital at Herlev
Sponsor institution
The Institute for the Blind and Partially Sighted (IBOS)
Collaborator
Copenhagen University Hospital at Herlev
Collaborator