Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas (VRT)
Primary Purpose
Scotoma, Central, Central Visual Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visuo-motor training
Sponsored by
About this trial
This is an interventional treatment trial for Scotoma, Central focused on measuring scotoma, central, visual motor coordination
Eligibility 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
Sites / Locations
- Kansas City VA Medical Center, Kansas City, MO
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Visuo-motor training for low vision
Arm Description
All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Stylus to Eclipse Area
Full Information
NCT ID
NCT01691027
First Posted
September 19, 2012
Last Updated
August 2, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01691027
Brief Title
Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas
Acronym
VRT
Official Title
Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scotoma, Central, Central Visual Impairment
Keywords
scotoma, central, visual motor coordination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visuo-motor training for low vision
Arm Type
Experimental
Arm Description
All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
Intervention Type
Behavioral
Intervention Name(s)
Visuo-motor training
Other Intervention Name(s)
Scotoma Awareness, Line and Circle Tracing, Video games (Pong and PacMan)
Intervention Description
Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation
Primary Outcome Measure Information:
Title
Improvement in Eye-hand Coordination
Description
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
Time Frame
base line, pre-test, post tracing and videogames training
Secondary Outcome Measure Information:
Title
Stylus to Eclipse Area
Time Frame
Base line, Pre and Post training (approximately 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George T Timberlake, PhD
Organizational Affiliation
Kansas City VA Medical Center, Kansas City, MO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City VA Medical Center, Kansas City, MO
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas
We'll reach out to this number within 24 hrs