Visuomotor Rehabilitation Training (VRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01691027
First received: September 19, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Scotoma, Central
Visual Motor Coordination
Behavioral: Practice tracing objects and printing with a stylus on a tablet computer
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Accuracy of retinal image position of stylus when tracing and printing and Preferred Retinal Locus characteristics measured with Scanning Laser Ophthalmoscope [ Time Frame: Scanning Laser Ophthalmoscope assessments after each of three training modules and three months after completion of training ] [ Designated as safety issue: No ]
    Images of the subject's hand and stylus on their retina while they trace mazes and print words are recorded with a Scanning Laser Ophthalmoscope. Retinal positions of the stylus, maze, and printed text are measured from the images. The retinal area for fixation (the PRL) is also measured.


Secondary Outcome Measures:
  • Change in time required to complete tracing a maze in the SLO. [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The time required to trace mazes before training is compared to the time required after training.

  • Stylus retinal bivariate ellipse area [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    Retinal positions of the stylus tip during maze tracing are measured and used to calculate a dispersion measure, the bivariate normal ellipse The smaller the ellipse, the more accurate the retinal position of the stylus.

  • Percentage of time the Preferred Retinal Locus (PRL) is on the maze during tracing. [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The amount of time the subject's PRL is on the maze is measured from SLO images. The change in percentage time the PRL is on the maze is compared from before training to after training.

  • Percentage of time the stylus is in the subject's scotoma [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The tip of the stylus cannot be seen by the subject when it is in their macular scotoma. It is thought the training regimen may reduce the time the stylus is obscured by the scotoma.

  • Percentage of time the stylus is on the maze [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The tracing stylus should remain on the maze when it is being traced but often leaves the maze. Training may improve the actual amount of time the stylus is on the maze.

  • Legibility of printing in the SLO [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    Subjects print simple words while looking into the SLO. Legibility of printing is scored based on letter legibility and placement relative to the printing guide. Training may improve printing legibility.

  • Printing completion time [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The time to complete printing each word is measured. Printing time before and after training are compared.

  • Stylus retinal bivariate ellipse area during printing [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The dispersion of the position of the stylus tip on the retina (bivariate ellipse area) is measured from SLO images. Pre-training and post-training ellipse areas are compared.

  • Percentage of time the stylus tip is in the subject's scotoma [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The amount of time the stylus tip is in the subject's scotoma during printing is measured. Percentages of time in the scotoma before and after training are compared.

  • Preferred Retinal Locus (PRL) retina area [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The retinal dispersion of a fixation target is measured before and after training. Training may improve fixation ability as indicated by a smaller PRL retinal bivariate area.

  • PRL retinal eccentricity [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    The position of the PRL relative to the position of the non-functional fovea will be measured before and after training. The position may change as a result of the training.

  • PRL visual acuity [ Time Frame: Pre treatment to Post treatment (approximately 3 months) ] [ Designated as safety issue: No ]
    Visual acuity will be measured at the PRL using the SLO. Visual acuity before training will be compared to that after training.


Estimated Enrollment: 35
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Crossover design. All subjects undergo all treatments.
Behavioral: Practice tracing objects and printing with a stylus on a tablet computer
Subjects will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion.
Other Name: computer visuo-motor training

Detailed 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, three visuo-motor training modules will be developed for low-cost tablet computers that subjects will use at home. Modules will be for scotoma awareness training, line and circle tracing, and video games. All three modules will involve PRL-hand coordination by moving a stylus on the tablet screen in response to stimuli. Scotoma awareness training is necessary because the majority of those with macular scotomas do not realize they have them. 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 others.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691027

Contacts
Contact: George T Timberlake, PhD (816) 861-4700 George.Timberlake@va.gov
Contact: Ram R Sharma, PhD MHSA (816) 922-2757 ram.sharma2@va.gov

Locations
United States, Missouri
Kansas City VA Medical Center, Kansas City, MO Recruiting
Kansas City, Missouri, United States, 64128
Contact: George T Timberlake, PhD    816-861-4700    George.Timberlake@va.gov   
Contact: Ram R Sharma, PhD MHSA    (816) 922-2757    ram.sharma2@va.gov   
Principal Investigator: George T Timberlake, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: George T Timberlake, PhD Kansas City VA Medical Center, Kansas City, MO
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01691027     History of Changes
Other Study ID Numbers: C1000-R
Study First Received: September 19, 2012
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
scotoma, central
visual motor coordination

Additional relevant MeSH terms:
Scotoma
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 23, 2014