Rehabilitation of Visual Function After Brain Injury

NCT03160131 | Recruiting

• 1 other identifier: H-17001534
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke, Ischemic; Brain Injuries; Stroke Hemorrhagic; Traumatic Brain Injury

Keywords

Stroke; Visual impairment; Hemianopia; Neuro Vision Technology; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Ability to complete a mobility route

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

  3 months

Secondary Outcomes (11)

• Time to complete a mobility route

  3 months

• National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)

  3 months

• Short Form (36) Health Survey (SF-36)

  3 months

• Montreal Cognitive Assessment (MoCA)

  3 months

• Fatigue Severity Scale-7

  3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

All participants receive NVT course training and are tested at baseline and at the end of the study for primary and secondary endpoints.

Device: Neuro Vision Technology

Control

NO INTERVENTION

All participants receive no NVT course training and are tested at baseline and at the end of the study for primary and secondary endpoints.

Interventions

Neuro Vision Technology DEVICE

Training using Neuro Vision Technology

Intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older with brain injury.
• Persons who experience significant vision impairment.
• Eye sight 6/18 or better.

You may not qualify if:

• 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.
• Terminal disorder, other progressive disorder.
• Significant abuse of alcohol or euphoric or narcotic drugs.
• Serious disorders such as mental illness, especially severe depression.
• Impaired vision not due to brain damage, where the disorder is not considered to be permanent or where the field of vision does not cause significant disability.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• The Institute for the Blind and Partially Sighted (IBOS): collaborator
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

The Institute for the Blind and Partially Sighted (IBOS)

Copenhagen, Hellerup, 2900, Denmark

RECRUITING

Related Publications (1)

• Rasmussen RS, Schaarup AMH, Overgaard K. Therapist-Assisted Rehabilitation of Visual Function and Hemianopia after Brain Injury: Intervention Study on the Effect of the Neuro Vision Technology Rehabilitation Program. JMIR Res Protoc. 2018 Feb 27;7(2):e65. doi: 10.2196/resprot.8334.

  PMID: 29487042 DERIVED

Related Links

• Therapist-Assisted Rehabilitation of Visual Function and Hemianopia after Brain Injury: Intervention Study on the Effect of the Neuro Vision Technology Rehabilitation Program

MeSH Terms

Conditions

Ischemic Stroke; Brain Injuries; Hemorrhagic Stroke; Brain Injuries, Traumatic; Stroke; Vision Disorders; Hemianopsia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blindness

Study Officials

• Karsten Overgaard, MD

  Copenhagen University Hospital at Herlev

  STUDY CHAIR

Central Study Contacts

Nanna F Mikkelsen, OT

CONTACT

+45 39 45 23 85; F52E@sof.kk.dk

Rune S Rasmussen, MA, Ph.D.

CONTACT

+45 28757500; rsr@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Ph.D., associate professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 19, 2017
• Study Start: August 1, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)