Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas

Central Visual Impairment Clinical Trial

— VRT  

Official title:

Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691027
• Other study ID #: C1000-R
• Status: Completed
• Phase: N/A
• First received: September 19, 2012
• Last updated: August 2, 2017
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research is aimed at developing and testing a new method of visual-motor rehabilitation of Veterans with macular degeneration by using inexpensive "tablet" computers at home.

Description:

The research objective is to test the hypothesis that practicing eye-hand coordination using tablet-computers can improve manual skills of those with Age-related Macular Degeneration (AMD). AMD causes the loss of sharp central vision used for reading and many other everyday activities. Those with AMD experience a "macular scotoma", a blanked-out area of whatever they're attempting to look at, and they must use an area of peripheral vision, the "Preferred Retinal Locus (PRL)" to look at objects of interest. The PRL does not provide sharp vision, causing deficits in eye-hand coordination needed for manual tasks. There have been few studies of visuo-motor rehabilitation training for deficits caused by macular scotomas. However, a recent study demonstrated that visuo-motor eye movement training dramatically improved reading ability of subjects with AMD. In addition, it has been shown that playing action video games can improve certain visual skills. Thus, a small but growing body of research suggests that it may be possible to ameliorate manual task deficits caused by AMD through computer-based visuo-motor rehabilitation training.

To test this idea, two visuo-motor training modules will be developed for low-cost tablet computers that subjects will use at home. Modules will be for, line and circle tracing, and video games. Both modules will involve PRL-hand coordination by moving a stylus on the tablet screen in response to stimuli. Line and circle tracing will develop eye-hand coordination skills needed for printing. The video game module will provide practice in PRL-hand coordination. Progress in PRL-hand coordination will be automatically recorded on the tablet-computer.

Changes in manual task performance from the training modules will be assessed after each training module using previously developed Scanning Laser Ophthalmoscope (SLO) tests of maze-tracing, and printing. The SLO will also be used to determine the position and fixation stability of the subject's PRL and the retinal position of the scotoma. SLO testing will be repeated three months after all training. Digitized SLO video images showing the hand, stylus, and object on the retina will be measured and analyzed. Several performance measures will be derived from the SLO image analysis including maze-tracing accuracy, printing legibility, retinal area of the stylus, percentage of time the stylus is in the scotoma, and PRL retinal area. This data will be statistically analyzed to determine whether visuo-motor training with the computer tablets improves manual task performance and whether one module is more effective than other.

There will be six groups of five subjects. Subjects will be assigned as they are recruited to a group until the group is full. Two groups will have training delayed by 6 months and will be tested on the SLO 4 times to assess changes in the dependent measure without training. Following training on each module, subject will be tested on maze tracing and printing in the SLO. Two groups undergo four SLO tests without training and begin training six months later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

Inclusion Criteria:

• Bilateral macular scotomas

• Preferred Retinal Locus (PRL) in at least one eye

• Visual acuity 20/400 or better in at least one eye

• No peripheral visual field loss

• No medications that could affect motor control

• Normal arm/hand range of motion

• Pass cognitive ability exam

Exclusion Criteria:

• No macular scotomas

• Visual acuity of 20/30 or better

• Medications that affect motor control

• Limited arm/hand range of motion

• Fail cognitive ability exam

Related Conditions & MeSH terms

• Central Visual Impairment
• Scotoma
• Scotoma, Central
• Vision Disorders
• Vision, Low

Intervention

Behavioral:
• Visuo-motor training
Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation

Locations

Country	Name	City	State
United States	Kansas City VA Medical Center, Kansas City, MO	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Eye-hand Coordination	Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination	base line, pre-test, post tracing and videogames training
Secondary	Stylus to Eclipse Area		Base line, Pre and Post training (approximately 3 months)