Accidental FallsPhase 1NCT00549406
Visual Training Program to Improve Balance and Prevent Falls in Older Adults
A Phase 1 study testing computerized visual training, computerized word puzzles and video-game based visual training in people with Accidental Falls and Musculoskeletal Equilibrium, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The ability to maintain balance and avoid falling is highly dependent on the ability to locate objects and architectural features in the environment. This need to continually monitor the environment as one moves about in daily life suggests a critical role for visual attention, gaze control, and spatial memory, all of… Read more about this study
- Who is it for?
- Ages 64 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Musculoskeletal Equilibrium
- What is being tested?
- computerized visual training, computerized word puzzles and video-game based visual training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 64 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community dwelling
- Functional mobility (no dependence on mobility aids)
- Impaired visual processing (UFOV divided attention score of 200ms or worse)
Who cannot join
- Neurological or musculoskeletal disorder
- Cognitive disorder (e.g. dementia)
- Uncorrected visual impairments
- Recurrent dizziness or unsteadiness
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Studies in Aging, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Visual Processing and Postural Reactions: Development and Pilot Testing of a "Visual Training" Program to Improve Balance Control and Prevent Falls in Older Adults
The ability to maintain balance and avoid falling is highly dependent on the ability to locate objects and architectural features in the environment. This need to continually monitor the environment as one moves about in daily life suggests a critical role for visual attention, gaze control, and spatial memory, all of which are known to decline with aging. In this study, the investigators will test the efficacy of a computer-based visual-training program designed to improve the ability to rapidly extract information from the peripheral visual field. It is expected that older adults involved in the visual training intervention will improve the speed, accuracy, and effectiveness of reach-to-grasp balance-recovery reactions evoked by sudden unpredictable balance perturbation.
Read the 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.
- Conditions
- Accidental Falls, Musculoskeletal Equilibrium
- Being tested
- computerized visual training, computerized word puzzles, video-game based visual training
- Keywords
- Vision, Visual attention, Postural balance, Geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized visual trainingProcedure or surgery
Also called "Useful Field of View" (UFOV) training
two one-hour training sessions per week, for five consecutive weeks
computerized word puzzlesProcedure or surgery
Also called "Super Text-Twist" puzzles
two one-hour sessions per week, for five consecutive weeks
video-game based visual trainingProcedure or surgery
Also called Video game training
two one-hour training sessions per week, for five consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | computer-based visual-training program UFOV Receives: Procedure: computerized visual training |
| 2 | Experimental | video-game based visual training Receives: Procedure: video-game based visual training |
| 3 | Placebo comparator | computerized word puzzles Receives: Procedure: computerized word puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
ability to use peripheral vision to recover balance by grasping a handhold
Measured: within one week of starting and completing the intervention
Secondary outcomes (1)
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
Measured: within one week of starting and completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startJun 2008
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Canadian Institutes of Health Research (CIHR)
- Investigators
- Brian E Maki, PhD, PEng, Principal investigator, Sunnybrook Health Sciences Centre, University of TorontoSandra M McKay, PhD, Principal investigator, Sunnybrook Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549406
- Sponsor's protocol ID
- 2007-PREV-INT-452
- Other IDs
- CIHR grant# MOP-13355
- Status last verified
- Dec 2014
- First submitted
- 24 Oct 2007
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Processing and Postural Reactions: Development and Pilot Testing of a "Visual Training" Program to Improve Balance Control and Prevent Falls in Older Adults
- ClinicalTrials.gov ID
- NCT00549406
- Acronym / sponsor ID
- 2007-PREV-INT-452
- Conditions
- Accidental Falls, Musculoskeletal Equilibrium
- Keywords
- Vision, Visual attention, Postural balance, Geriatrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ability to maintain balance and avoid falling is highly dependent on the ability to locate objects and architectural features in the environment. This need to continually monitor the environment as one moves about in daily life suggests a critical role for visual attention, gaze control, and spatial memory, all of which are known to decline with aging. In this study, the investigators will test the efficacy of a computer-based visual-training program designed to improve the ability to rapidly extract information from the peripheral visual field. It is expected that older adults involved in the visual training intervention will improve the speed, accuracy, and effectiveness of reach-to-grasp balance-recovery reactions evoked by sudden unpredictable balance perturbation.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: computerized visual trainingcomputer-based visual-training program UFOV |
| 2 | Experimental | Procedure: video-game based visual trainingvideo-game based visual training |
| 3 | Placebo comparator | Procedure: computerized word puzzlescomputerized word puzzles |
Who may qualify
- Ages
- 64 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community dwelling
- Functional mobility (no dependence on mobility aids)
- Impaired visual processing (UFOV divided attention score of 200ms or worse)
Key exclusion criteria (4 listed)
- Neurological or musculoskeletal disorder
- Cognitive disorder (e.g. dementia)
- Uncorrected visual impairments
- Recurrent dizziness or unsteadiness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized visual trainingAlso: "Useful Field of View" (UFOV) trainingtwo one-hour training sessions per week, for five consecutive weeks | Procedure or surgery | 1 |
| computerized word puzzlesAlso: "Super Text-Twist" puzzlestwo one-hour sessions per week, for five consecutive weeks | Procedure or surgery | 3 |
| video-game based visual trainingAlso: Video game trainingtwo one-hour training sessions per week, for five consecutive weeks | Procedure or surgery | 2 |
Primary outcome
ability to use peripheral vision to recover balance by grasping a handhold
Time frame: within one week of starting and completing the intervention
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian E Maki, PhD, PEng principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
Sandra M McKay, PhD principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing computerized visual training, computerized word puzzles and video-game based visual training in people with Accidental Falls and Musculoskeletal Equilibrium, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability to use peripheral vision to recover balance by grasping a handhold (time frame: within one week of starting and completing the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.