Accidental FallsNCT02030743
A Study of Visual Attention Training to Improve Balance and Mobility
A study testing Visual training in people with Accidental Falls, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to determine if training visual attention improves balance and mobility, and reduces falls in older adults. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Visual training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- healthy older adults
- Visual acuity 6/12 or better
- able to speak English
Who cannot join
- No known dementia or cognitive impairment
- not dependent on a walker or cane
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if training visual attention improves balance and mobility, and reduces falls in older adults.
Read the detailed description
Visual training in visual attention is compared with activity as usual.
- Conditions
- Accidental Falls
- Being tested
- Visual training
- Keywords
- Falls, Older adults, Balance, Mobility, Visual attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual trainingOther
6 training sessions with computerised visual attention paradigm
| Study group | Role | What they receive |
|---|---|---|
| Visual training | Active comparator | Training in visual attention Receives: Other: Visual training |
| Usual activity | Placebo comparator | Usual activity Receives: Other: Visual training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance on force plate platform
Standard deviation of the medial lateral (ML) and anterior posterior (AP) center of pressure, ML and AP CoP maximum sway, ML and AP CoP range in each direction (range = maximum excursion - minimum excursion) and the cumulative path length in cms
Measured: after 4 weeks
Secondary outcomes (1)
Mini-BESTest (Balance evaluation)
14 short balance tests divided under four domains of balance control; 1) anticipatory body control, 2) reactive postural control, 3) sensory orientation and 4) balance during dynamic gait
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionAug 2015
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Sponsor
- Investigators
- Susan J. Leat, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030743
- Sponsor's protocol ID
- 19456
- Status last verified
- Dec 2015
- First submitted
- 7 Jan 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Visual Attention Training to Improve Balance and Mobility
- ClinicalTrials.gov ID
- NCT02030743
- Acronym / sponsor ID
- 19456
- Conditions
- Accidental Falls
- Keywords
- Falls, Older adults, Balance, Mobility, Visual attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Jan 2014 (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 purpose of this study is to determine if training visual attention improves balance and mobility, and reduces falls in older adults.
Detailed description
Visual training in visual attention is compared with activity as usual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual training | Active comparator | Other: Visual trainingTraining in visual attention |
| Usual activity | Placebo comparator | Other: Visual trainingUsual activity |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- healthy older adults
- Visual acuity 6/12 or better
- able to speak English
Key exclusion criteria (2 listed)
- No known dementia or cognitive impairment
- not dependent on a walker or cane
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 |
|---|---|---|
| Visual training6 training sessions with computerised visual attention paradigm | Other | Usual activity, Visual training |
Primary outcome
Balance on force plate platform
Time frame: after 4 weeks
Standard deviation of the medial lateral (ML) and anterior posterior (AP) center of pressure, ML and AP CoP maximum sway, ML and AP CoP range in each direction (range = maximum excursion - minimum excursion) and the cumulative path length in cms
1 secondary outcome
Mini-BESTest (Balance evaluation)
Time frame: after 4 weeks
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 16 Apr 2019.
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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.
Susan J. Leat, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual training in people with Accidental Falls, run by University of Waterloo 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 2 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 16 Apr 2019. 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.
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?
Balance on force plate platform (time frame: after 4 weeks). 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 16 Apr 2019.