Clinical Trial: Rehabilitation of Visual Function After Brain Injury

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Rehabilitation of Visual Function After Brain Injury - Effect of Neuro Vision Technology (NVT)

Brief Summary:

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

Detailed Summary:

Background and purpose Stroke is the main cause of brain injury in Denmark, is the most common cause of invalidity among adults and affects 11,000 Danes annually. By comparison, the second most common cause of brain damage is traumatic brain injury, affecting 3,000 Danes annually. In total, approx. 22,000 children and adults annually experience brain injury in Denmark.

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 with stroke. In general, vision is the most important sense in humans, thus even small permanent deficits can dramatically affect the quality of life.

Lack of vision (anopia) after brain damage limits rehabilitation and enhances other invalidating effects. Impaired 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. Recovery of visual field deficits occurs primarily and only to a modest extent the first month after brain injury, and thus 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 a supervised training course where people with visual field deficits are trained in compensatory and restorative techniques. The course includes a special computer program, a light panel and a special training program, and the course is conducted with Certified Orientation & Mobility Instructors (O & M instructors) with visual expertise. Through the NVT cours
Sponsor: University Hospital, Gentofte, Copenhagen

Current Primary Outcome: Ability to complete a mobility route [ Time Frame: 3 months ]

Target identification and thus to compare how many targets are seen after the intervention.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to complete a mobility route [ Time Frame: 3 months ]
    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) [ Time Frame: 3 months ]
    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) [ Time Frame: 3 months ]
    Assessment of quality of life. Measured in points summing up several scales.
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: 3 months ]
    Cognitive screening test that provides an estimate of the intellectual functional level.
  • Fatigue Severity Scale-7 [ Time Frame: 3 months ]
    Short fatigue test.
  • Multidimensional Fatigue Inventory 20 (MFI-20) [ Time Frame: 3 months ]
    Fatigue test used to assess the occurrence of physical fatigue, mental fatigue, activity level, motivation and general fatigue.
  • Test of Attentional Performance (TAP) Test 2.3: Visual Field [ Time Frame: 3 months ]
    Test for field defects in which the subject will respond quickly to stimuli in the field of view.
  • Behavioral Inattention Test (BIT) [ Time Frame: 3 months ]
    Test of attention and vision.
  • Rey-Osterrieth's complex figure test [ Time Frame: 3 months ]
    Copying advanced visual figure (without recall).
  • Modified Barthel-100 Index [ Time Frame: 3 months ]
    Assessment of invalidity rate and ability to perform activities of daily living.
  • Hemisphere differences [ Time Frame: 3 months ]
    As part of the study, it will be assessed whether persons with lesion of right hemisphere, ie left-field hemianopia may be more likely to be disorientated and due to neglect will overlook more details - this is done by comparing trial participants with right vs. left hemispheric lesions.


Original Secondary Outcome: Same as current

Information By: University Hospital, Gentofte, Copenhagen

Dates:
Date Received: May 10, 2017
Date Started: August 1, 2017
Date Completion: July 31, 2020
Last Updated: May 17, 2017
Last Verified: May 2017