Falls, AccidentalWiiFitNCT01229969
A Pilot Study of the Wii Fit as a Low-Cost Virtual Reality System to Evaluate Balance Ability in Older Adults
A study testing Wii Fit Balance Games and NeuroCom EquiTest® System in people with Falls, Accidental, run by Atlanta VA Medical Center at 1 site in United States.
Trial summary
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls, Accidental
- What is being tested?
- Wii Fit Balance Games and NeuroCom EquiTest® System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2012
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 60 years of age or older
- Reside in the community
- Who are with and without balance or gait issues
Who cannot join
- Impaired mental status, patient scores <21 on Montreal Cognitive Assessment (MoCA)
- Unable to ambulate without an assistive walking device
- Cannot stand independently for 20 minutes of testing over a 30min period
- Unstable medical conditions
- Active cardiopulmonary
- Degenerative neuro-sensory conditions
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- Severe pain with weight bearing
- Vision Impairment
- Weighing more than 300 pounds (150kg)
- Used Wii Fit equipment in the past
Trial locations and contacts
1 site in 1 country.
About this study
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite of exercise and fitness video games using a balance board periphery developed for the Wii console. The purpose of this study is to determine the feasibility and validity of the Nintendo Wii Fit, in detecting balance problems in older community dwelling adults.20 ambulatory older adults will be recruited to participate in this study.Subject will be asked to complete 1 study visit. In this visit information will be gathered about the subjects overall health including fall assessments. Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order.
Read the detailed description
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. Falls are also costly. An estimate $20 billion dollars annually has been spent on hip fractures associated with falls; this amount is projected to rise in the next decade. Risk factors for falls in the elderly are usually multi-factorial. These include increasing age, environmental factors, acute or chronic illness, medication use, cognitive impairment, sensory deficits, and balance and gait impairment.
The Nintendo Wii Fit system is engaging, low-cost, and standardized and may be a feasible exercise modality to improve balance in the elderly. While virtual reality use in a research context is not new, few studies of commercially available low-cost video games with virtual reality capabilities have been done. These have demonstrated encouraging results, indicating a potential use for rehabilitation in both children and adults.
Twenty ambulatory older individuals age 60 and older who reside in the community will be recruited to participate in this study.This group of participants will be selected to represent the general community dwelling older adults as much as possible. They will demonstrate a wide range of ability in terms of their balance and mobility in which some are healthy (non-fallers), some with risks of falling, and some fallers. Efforts will be made to have equal distribution among these three groups.
Subjects will be consented for the research study and we will ask questions about age, gender, educational background, medical history, and any falls in past year. They will also be evaluated clinically before the actual study to assess vision, cognitive status, and balance.
Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order. This counterbalancing between subjects is designed to negate any potential order effect. Balance data collected from the NeuroCom EquiTest will be compared to the performance scores obtained from playing the two Wii Fit balance games to determine whether the performance scores on the two Wii Fit balance games are indicative of the participants' balance ability.All study interventions are completed in a 1 day session.
- Conditions
- Falls, Accidental
- Being tested
- Wii Fit Balance Games, NeuroCom EquiTest® System
- Keywords
- falls, balance problems, gaming systems, balance assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii Fit Balance GamesOther
Also called Ski Slaloms and Table Tilt
Ski Slaloms and Table Tilt
NeuroCom EquiTest® SystemOther
Also called SOT and LOS
Sensory Organization Test (SOT) and Limit of Stability (LOS).
| Study group | Role | What they receive |
|---|---|---|
| NeuroCom EquiTest® System | Experimental | Measure balance assessment (test for Sensory Organization Test (SOT) and Limit of Stability (LOS). Receives: Other: NeuroCom EquiTest® System |
| Wii Fit | Experimental | Determine if the Wii Fit is valid and feasible in detecting balance problems in older adults Receives: Other: Wii Fit Balance Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and validity of the Wii Fit gaming system in detect balance problems in older adults
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls, AccidentalStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Theodore Johnson II, M.D., M.P.H., Atlanta VA Medical Center
- Investigators
- Theodore M Johnson, MD,MPH, Principal investigator, Atlanta Veteran Affairs Adminstration, Emory University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229969
- Sponsor's protocol ID
- 2009-060390
- Other IDs
- 2009
- Acronym
- WiiFit
- Status last verified
- Jan 2013
- First submitted
- 27 Oct 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Wii Fit as a Low-Cost Virtual Reality System to Evaluate Balance Ability in Older Adults
- ClinicalTrials.gov ID
- NCT01229969
- Acronym / sponsor ID
- WiiFit / 2009-060390
- Conditions
- Falls, Accidental
- Keywords
- falls, balance problems, gaming systems, balance assessments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Collaborators
- Emory University
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Oct 2010 (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.
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite of exercise and fitness video games using a balance board periphery developed for the Wii console. The purpose of this study is to determine the feasibility and validity of the Nintendo Wii Fit, in detecting balance problems in older community dwelling adults.20 ambulatory older adults will be recruited to participate in this study.Subject will be asked to complete 1 study visit. In this visit information will be gathered about the subjects overall health including fall assessments. Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order.
Detailed description
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. Falls are also costly. An estimate $20 billion dollars annually has been spent on hip fractures associated with falls; this amount is projected to rise in the next decade. Risk factors for falls in the elderly are usually multi-factorial. These include increasing age, environmental factors, acute or chronic illness, medication use, cognitive impairment, sensory deficits, and balance and gait impairment.
The Nintendo Wii Fit system is engaging, low-cost, and standardized and may be a feasible exercise modality to improve balance in the elderly. While virtual reality use in a research context is not new, few studies of commercially available low-cost video games with virtual reality capabilities have been done. These have demonstrated encouraging results, indicating a potential use for rehabilitation in both children and adults.
Twenty ambulatory older individuals age 60 and older who reside in the community will be recruited to participate in this study.This group of participants will be selected to represent the general community dwelling older adults as much as possible. They will demonstrate a wide range of ability in terms of their balance and mobility in which some are healthy (non-fallers), some with risks of falling, and some fallers. Efforts will be made to have equal distribution among these three groups.
Subjects will be consented for the research study and we will ask questions about age, gender, educational background, medical history, and any falls in past year. They will also be evaluated clinically before the actual study to assess vision, cognitive status, and balance.
Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order. This counterbalancing between subjects is designed to negate any potential order effect. Balance data collected from the NeuroCom EquiTest will be compared to the performance scores obtained from playing the two Wii Fit balance games to determine whether the performance scores on the two Wii Fit balance games are indicative of the participants' balance ability.All study interventions are completed in a 1 day session.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroCom EquiTest® System | Experimental | Other: NeuroCom EquiTest® SystemMeasure balance assessment (test for Sensory Organization Test (SOT) and Limit of Stability (LOS). |
| Wii Fit | Experimental | Other: Wii Fit Balance GamesDetermine if the Wii Fit is valid and feasible in detecting balance problems in older adults |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants 60 years of age or older
- Reside in the community
- Who are with and without balance or gait issues
Key exclusion criteria (10 listed)
- Impaired mental status, patient scores <21 on Montreal Cognitive Assessment (MoCA)
- Unable to ambulate without an assistive walking device
- Cannot stand independently for 20 minutes of testing over a 30min period
- Unstable medical conditions
- Vision Impairment
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 |
|---|---|---|
| Wii Fit Balance GamesAlso: Ski Slaloms and Table TiltSki Slaloms and Table Tilt | Other | Wii Fit |
| NeuroCom EquiTest® SystemAlso: SOT and LOSSensory Organization Test (SOT) and Limit of Stability (LOS). | Other | NeuroCom EquiTest® System |
Primary outcome
Feasibility and validity of the Wii Fit gaming system in detect balance problems in older adults
Time frame: 8 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 24 Jan 2013.
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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.
Theodore M Johnson, MD,MPH principal investigator
Atlanta Veteran Affairs Adminstration, Emory University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii Fit Balance Games and NeuroCom EquiTest® System in people with Falls, Accidental, run by Atlanta VA Medical Center at 1 site in United States.
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 10 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 24 Jan 2013. 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 United States. 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. 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?
Feasibility and validity of the Wii Fit gaming system in detect balance problems in older adults (time frame: 8 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 24 Jan 2013.