- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00549406
Visual Training Program to Improve Balance and Prevent Falls in Older Adults
Visual Processing and Postural Reactions: Development and Pilot Testing of a "Visual Training" Program to Improve Balance Control and Prevent Falls in Older Adults
Study Overview
Status
Conditions
Detailed Description
Balance reactions that involve rapidly stepping or reaching to grasp a handrail or other objects for support play a crucial role in preventing us from falling when we lose our balance. However, to recover balance successfully, the central nervous system has to be able to control the stepping or grasping movement to deal with "environmental constraints" (i.e. objects and architectural features that can obstruct stepping or serve as handholds to grasp), and hence must somehow monitor the location of potential constraints as we move about in our daily lives. The need to monitor these environmental features suggests a critical role for visual attention, gaze control, and spatial memory, all of which are known to decline with aging. Although no studies have examined the effects on balance control, it is known that such deficits can impair other motor behaviors such as driving and can be successfully countered using a computer-based "visual training" intervention designed to improve the ability to rapidly extract information from the peripheral visual field (the so-called "Useful Field of View", or UFOV).
The proposed research will use an analogous approach to improve balance control. Specifically, we will test whether: 1) the UFOV® computer-based visual-training program or a commercially available video game leads to improved ability to use peripheral vision to monitor changes in the spatial features of the surrounding environment, and 2) whether such changes in visual processing are associated with improved ability to rapidly reach and grasp a handrail for support, in response to a sudden unpredictable balance perturbation. Older adults with documented deficits in UFOV scores will be randomly assigned to either the visual training (UFOV or video game) or a control group. Each training group will undergo two one-hour sessions per week, for five consecutive weeks. Neither group will be given any information as to which training method is expected to be more beneficial.
Participants in the experimental group will complete either the computerized UFOV® speed-of-processing intervention or the video game training intervention. This UFOV intervention focuses on the ability to quickly identify and locate visual targets presented (for brief time intervals) in the central and peripheral visual fields. The training challenges the participant to identify the target(s) in the briefest display duration possible, within increasingly difficult task conditions. Difficulty of the training task is increased by making it more difficult to identify the central target, decreasing the duration of target presentation time, increasing the number of tasks to complete simultaneously, adding distracters, and increasing the eccentricity (visual angle) of the peripheral targets.
Participants in the video game training group will participate in game play sessions using a cartoon-based action video game with increasing levels of challenge and difficulty.
Participants in the control group will complete timed computerized word puzzles during the training sessions. This cognitive task involves levels of social interaction and computer use similar to the experimental group, but is not expected to yield improvements in ability to rapidly process peripheral visuospatial information.
Balance assessments will be performed immediately before and after completion of the intervention programs. Balance perturbations will be delivered using a large (2x2m) computer-controlled motion platform. Subjects will stand at the center of the platform and a motor-driven moveable handhold system will be mounted to the front wall of the platform. In each trial, the handhold (a 10cm rod) will be controlled to move, intermittently and unpredictably, back and forth along a horizontal axis in the frontal plane, before coming to rest at one of four final locations (corresponding to visual angles of 5, 10, 15, and 20 degrees). The moving platform will deliver a small perturbation a few seconds after the final handhold location is reached. Subjects will be told to grasp the handhold as quickly as possible in response to the platform motion. During each trial, subjects will perform a concurrent visual vigilance task, which requires them to continuously look straight ahead at the center of a computer screen. This task is designed to ensure the subjects rely on peripheral vision to acquire the spatial information needed to direct the hand toward the handhold following the onset of the platform perturbation. The absence of any eye movements toward the grasp location will be confirmed via recordings from a head-mounted eye tracker. A motion-analysis system will be used to determine the speed and accuracy of the grasping reactions.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Centre for Studies in Aging, Sunnybrook Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community dwelling
- Functional mobility (no dependence on mobility aids)
- Impaired visual processing (UFOV divided attention score of 200ms or worse)
Exclusion Criteria:
- Neurological or musculoskeletal disorder
- Cognitive disorder (e.g. dementia)
- Uncorrected visual impairments
- Recurrent dizziness or unsteadiness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
computer-based visual-training program UFOV
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two one-hour training sessions per week, for five consecutive weeks
Other Names:
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Experimental: 2
video-game based visual training
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two one-hour training sessions per week, for five consecutive weeks
Other Names:
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Placebo Comparator: 3
computerized word puzzles
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two one-hour sessions per week, for five consecutive weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ability to use peripheral vision to recover balance by grasping a handhold
Time Frame: within one week of starting and completing the intervention
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within one week of starting and completing the intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
natural gaze and balance-recovery behavior (in responding to a sudden unpredictable balance perturbation while walking in an unfamiliar environment); clinical balance measures; visual-processing measures
Time Frame: within one week of starting and completing the intervention
|
within one week of starting and completing the intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brian E Maki, PhD, PEng, Sunnybrook Health Sciences Centre, University of Toronto
- Principal Investigator: Sandra M McKay, PhD, Sunnybrook Health Sciences Centre, University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2007-PREV-INT-452
- CIHR grant# MOP-13355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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