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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visuo-motor training for low vision | Experimental | All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visuo-motor training | Behavioral | Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stylus to Eclipse Area | Base line, Pre and Post training (approximately 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George T Timberlake, PhD | Kansas City VA Medical Center, Kansas City, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City VA Medical Center, Kansas City, MO | Kansas City | Missouri | 64128 | United States |
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Enrolled subjects when found to have residual foveal vision in baseline SLO retinal functional map and/or are unable to follow the instructions for SLO testing were excluded from the study before training assignment.
Subjects with bilateral AMD, no foveal vision, and acuities poorer than 20/60 in each eye were screened in the eye clinic and those who met inclusion criteria were enrolled in the study. On each laboratory visit, subjects' eyes were checked for angle closure and, if angles wee open, dilated the eye to be tested
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| ID | Title | Description |
|---|---|---|
| FG000 | Visuo-motor Training for Low Vision | All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Scotoma Awareness |
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| Line and Circle Tracing Training |
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| Video Games Training |
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For each subject, SLO retinal functional maps are shown for Baseline, Pre-training, Post line and Circle Tracing training, and Post Video Game training for both maze tracing and printing. Tables show data derived from the retinal maps and associated performance measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Design. All Subjects Undergo All Treatments. | Each participating subject 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only 4 subjects with ages in range of 65 to 92 participated and were able to complete all training. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing. | Posted | Number | Percentage | base line, pre-test, post tracing and videogames training |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Bilateral AMD, no Foveal Vision and 20/60 Vision | Crossover design. All subjects undergo all treatments. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Health Scientist | Kansas City VA Medical center | 816-861-4700 | 52755 | George.Timberlake@va.gov |
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| ID | Term |
|---|---|
| D012607 | Scotoma |
| D019575 | Blindness, Cortical |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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All eligible subjects trained on three computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before and after each training module.
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|
| Mean |
| Full Range |
| Years |
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| Sex: Female, Male | Four subjects 1 female and 3 males participated and completed all testing | Count of Participants | Participants |
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| SLO retinal functional map | Mean | Full Range | percent traced |
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| Secondary | Stylus to Eclipse Area | Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing. | Posted | Number | Degree | Base line, Pre and Post training (approximately 3 months) |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001766 | Blindness |
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| Participant 1 post tracing |
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| Participating 3 post games |
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