Skip to content

Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas

Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01691027
Acronym
VRT
Enrollment
4
Registered
2012-09-24
Start date
2013-07-31
Completion date
2015-12-31
Last updated
2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Visual Impairment, Scotoma, Central

Keywords

scotoma, central, visual motor coordination

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.

Interventions

BEHAVIORALVisuo-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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Eye-hand Coordinationbase line, pre-test, post tracing and videogames trainingMaze 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

MeasureTime frame
Stylus to Eclipse AreaBase line, Pre and Post training (approximately 3 months)

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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.

Participants by arm

ArmCount
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.
4
Total4

Baseline characteristics

CharacteristicCrossover Design. All Subjects Undergo All Treatments.
Age, Continuous84.5 Years
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
3 Participants
SLO retinal functional map80 percent traced

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 4
other
Total, other adverse events
0 / 4
serious
Total, serious adverse events
0 / 4

Outcome results

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

Time frame: base line, pre-test, post tracing and videogames training

Population: 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.

ArmMeasureGroupValue (NUMBER)
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 1 post gaming71.0 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 2 baseline76.8 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 2 pretest54.8 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 1 baseline42.8 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 1 pretest45.4 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 1 post tracing30.4 Percentage
Visuo-motor TrainingImprovement in Eye-hand Coordinationparticipant 2 post tracing51.0 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 2 post games94.3 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 3 baseline68.7 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 3 pre test79.9 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 3 post tracing95.5 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipating 3 post games95.1 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 4 baseline44 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 4 pre test30.5 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 4 post tracing65.8 Percentage
Visuo-motor TrainingImprovement in Eye-hand CoordinationParticipant 4 post games62.3 Percentage
Secondary

Stylus to Eclipse Area

Time frame: Base line, Pre and Post training (approximately 3 months)

Population: 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.

ArmMeasureGroupValue (NUMBER)
Visuo-motor TrainingStylus to Eclipse AreaParticipant 4 post games11.8 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 1 baseline45.2 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 1 pre test77.6 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 1 post tracing39.4 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 1 post games40.8 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 2 base line26.8 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 2 pre test22.6 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 2 post tracing20.9 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 2 post games11.1 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 3 base line25 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 3 pre test21.8 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 3 post tracing47.4 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipating 3 post games47.1 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipnat 4 base line28.4 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 4 pre test14.6 Degree
Visuo-motor TrainingStylus to Eclipse AreaParticipant 4 post tracing17.8 Degree

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026