Distorted; BalanceNCT01438671
Wii Fit Balance Training Compared to Traditional Balance Training in Patients With SCI/TBI/CVA
A study testing Nintendo Wii Fit and Traditional balance training in people with Distorted; Balance, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Our hypothesis is the investigators will find a significant advantage for the use of a virtual reality system like the Wii Fit to improve overall balance scores versus the use of traditional balance activities alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distorted; Balance
- What is being tested?
- Nintendo Wii Fit and Traditional balance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acquired neurological diagnosis
- 18 years of age or greater
- Score greater than or equal to an 18 on the MME and/or have a FIM score of 5 in comprehension and problem solving.
- Ability to stand with no greater than minimal assist (FIM score of 4, less than or equal to 25% assist)
- Vision that is WFL with or without glasses/contacts
- Ability to stand for at least 5 minutes without rest.
- Have at least a WBAT status
Who cannot join
- Person that is less than 18 years of age
- Person scoring less than an 18 on the MME and/or a FIM score of a 4 or lower in comprehension and problem solving.
- Person with the inability to stand without minimal assist
- Inability to stand for 5 minutes without rest
- Impaired vision
- Weight bearing precautions of 50%WB or NWB on either lower extremity
Show all 9Show fewer
- Any vestibular diagnoses
- Pain that limits participation
- Uncontrollable medical complications
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Rehabilitation Center
Mount Vernon, Missouri, 65712
About this study
Official title: Does Wii Fit Balance Training Significantly Improve Standing Balance Compared to Traditional Balance Training and Is Wii Fit Balance Training Preferred Over Traditional Balance Training by Patients With SCI/TBI/CVA?
Our hypothesis is the investigators will find a significant advantage for the use of a virtual reality system like the Wii Fit to improve overall balance scores versus the use of traditional balance activities alone. The objectives will be to determine the enjoyment of these types of gaming activities through the use of a survey to support the hypothesis that these activities are more enjoyable than traditional activities and to gather evidence to support the use of these more enjoyable activities as a viable and needed addition to the overall balance regimen given in the plan of care for a patient with traumatic or acquired brain injury, stroke or spinal cord injury.
Read the detailed description
In the recent past and currently, the Wii Fit has been and will probably continue to be used as an effective rehabilitation aide in improving balance and coordination in all populations. It is another tool amongst traditional balance activities to assist the therapist and patient in reaching the goals of both parties and improving overall functional outcomes for the patient. The Wii Fit is capable of giving objective data in a stimulating environment in which to deliver fun yet effective and measurable balance training. The addition of fun and enjoyment is found in most populations using a virtual reality system like the Wii. (VR Rehab, 2008) Brumels et al suggested having lack of interest in an activity can lead to less than desired engagement and performance (Comparison, 2008), which can lead to overall less improvement. This was supported at the conclusion of their study, indicating scientific reason to include the use of video game based programs in clinical settings. If someone is interested in a task because it is enjoyable and it keeps their interest over and over then, because of the increased time practicing due to the desire to actually participate, they are more inclined to make improvements in the task being practiced. In the case of this study, balance would be the task improving.
However, the same investigators concluded further research is required in order to determine the utility of an off-the-shelf gaming system like the Wii. One purpose of this project is to determine the effectiveness of this type of system with the hopes of eventually working with a company like Nintendo to make adjustments to their software and hardware systems in order to provide a comprehensive and adaptive system to deliver balance re-education to multiple populations. We also would like to determine, through the use of participant satisfaction surveys, if individuals prefer the use of a system like the Wii Fit over traditional balance exercises since improvements in balance can be linked to improved participation based on the enjoyment of the activity. If we can show that both the Wii Fit system itself is a viable apparatus with which to address and improve balance outside of traditional balance activities and that participants enjoy this method of balance activities then we open up the opportunity for a larger number of ways to assist in balance recovery for those affected with some sort of balance deficit. As the study by S M Flynn, et al, concluded, the use of systems like the WiiFit may encourage individuals to "play" with and against others promoting a healthier and less isolating lifestyle.
The clinical trials in this study will be conducted in compliance with the mentioned protocol and within the regulations set by the University of Missouri and the Missouri Rehabilitation Center. The population to be studied will be individuals from the ages of 16-70 with varying degrees of functional abilities after traumatic or acquired brain injury, stroke or spinal cord injury who do possess the physical capabilities as explained in the below inclusion and exclusion criteria.
- Conditions
- Distorted; Balance
- Being tested
- Nintendo Wii Fit, Traditional balance training
- Keywords
- WiiFit, Standing Balance, Neurological Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii FitProcedure or surgery
The Nintendo Wii Fit is an accessory for the Nintendo Wii video game system that utilizes a balance board peripheral. The subject stands on the balance board and engages in video games that require weight shifting and balancing in order to interact with the game. This intervention will be administered for 30 minutes, 3 to 5 times per week (as tolerated by subject), for a two week period.
Traditional balance trainingProcedure or surgery
This physical therapy intervention involves gait training, balance education on various surfaces, activities involving limited and changing bases of support, and dynamic interaction with the subject's environment. This intervention will be administered 30 minutes per day, 3 to 5 days per week (by subject's tolerance), for a two week period.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Nintendo Wii Fit Balance training followed by traditional balance training Receives: Procedure: Nintendo Wii Fit; Procedure: Traditional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
WiiFit
For standing balance we will be using the Berg Balance Scale and Single Leg Stance.
The investigators will also be looking at weight bearing symmetry utilizing the intrinsic tests included with the Nintendo Wii Fit ™ Measurements will be taken at baseline (pre-intervention), and at conclusion of each intervention phase (after 2 weeks of traditional balance therapy and then again after 2 weeks of training using the Nintendo Wii Fit ™)
Measured: Before and after two consecutive 2 week periods: one period without intervention, one with
Secondary outcomes (1)
Satisfaction
For patient preferences in intervention we will be using the Intrinsic Motivation Inventory.
Measured: Post Intervention (at conclusion of two 2 week trials)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Facility where study was taking place closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distorted; BalanceStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey D. Mosley, PT, Principal investigator, Missouri Rehabilitation Center, University of Missouri Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438671
- Sponsor's protocol ID
- 1179437
- Status last verified
- Sep 2016
- First submitted
- 2 Aug 2011
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Wii Fit Balance Training Significantly Improve Standing Balance Compared to Traditional Balance Training and Is Wii Fit Balance Training Preferred Over Traditional Balance Training by Patients With SCI/TBI/CVA?
- ClinicalTrials.gov ID
- NCT01438671
- Acronym / sponsor ID
- 1179437
- Conditions
- Distorted; Balance
- Keywords
- WiiFit, Standing Balance, Neurological Population
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Facility where study was taking place closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Sep 2011 (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.
Our hypothesis is the investigators will find a significant advantage for the use of a virtual reality system like the Wii Fit to improve overall balance scores versus the use of traditional balance activities alone. The objectives will be to determine the enjoyment of these types of gaming activities through the use of a survey to support the hypothesis that these activities are more enjoyable than traditional activities and to gather evidence to support the use of these more enjoyable activities as a viable and needed addition to the overall balance regimen given in the plan of care for a patient with traumatic or acquired brain injury, stroke or spinal cord injury.
Detailed description
In the recent past and currently, the Wii Fit has been and will probably continue to be used as an effective rehabilitation aide in improving balance and coordination in all populations. It is another tool amongst traditional balance activities to assist the therapist and patient in reaching the goals of both parties and improving overall functional outcomes for the patient. The Wii Fit is capable of giving objective data in a stimulating environment in which to deliver fun yet effective and measurable balance training. The addition of fun and enjoyment is found in most populations using a virtual reality system like the Wii. (VR Rehab, 2008) Brumels et al suggested having lack of interest in an activity can lead to less than desired engagement and performance (Comparison, 2008), which can lead to overall less improvement. This was supported at the conclusion of their study, indicating scientific reason to include the use of video game based programs in clinical settings. If someone is interested in a task because it is enjoyable and it keeps their interest over and over then, because of the increased time practicing due to the desire to actually participate, they are more inclined to make improvements in the task being practiced. In the case of this study, balance would be the task improving.
However, the same investigators concluded further research is required in order to determine the utility of an off-the-shelf gaming system like the Wii. One purpose of this project is to determine the effectiveness of this type of system with the hopes of eventually working with a company like Nintendo to make adjustments to their software and hardware systems in order to provide a comprehensive and adaptive system to deliver balance re-education to multiple populations. We also would like to determine, through the use of participant satisfaction surveys, if individuals prefer the use of a system like the Wii Fit over traditional balance exercises since improvements in balance can be linked to improved participation based on the enjoyment of the activity. If we can show that both the Wii Fit system itself is a viable apparatus with which to address and improve balance outside of traditional balance activities and that participants enjoy this method of balance activities then we open up the opportunity for a larger number of ways to assist in balance recovery for those affected with some sort of balance deficit. As the study by S M Flynn, et al, concluded, the use of systems like the WiiFit may encourage individuals to "play" with and against others promoting a healthier and less isolating lifestyle.
The clinical trials in this study will be conducted in compliance with the mentioned protocol and within the regulations set by the University of Missouri and the Missouri Rehabilitation Center. The population to be studied will be individuals from the ages of 16-70 with varying degrees of functional abilities after traumatic or acquired brain injury, stroke or spinal cord injury who do possess the physical capabilities as explained in the below inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Procedure: Nintendo Wii Fit, Procedure: Traditional balance trainingNintendo Wii Fit Balance training followed by traditional balance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acquired neurological diagnosis
- 18 years of age or greater
- Score greater than or equal to an 18 on the MME and/or have a FIM score of 5 in comprehension and problem solving.
- Ability to stand with no greater than minimal assist (FIM score of 4, less than or equal to 25% assist)
- Vision that is WFL with or without glasses/contacts
Key exclusion criteria (9 listed)
- Person that is less than 18 years of age
- Person scoring less than an 18 on the MME and/or a FIM score of a 4 or lower in comprehension and problem solving.
- Person with the inability to stand without minimal assist
- Inability to stand for 5 minutes without rest
- Impaired vision
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 |
|---|---|---|
| Nintendo Wii FitThe Nintendo Wii Fit is an accessory for the Nintendo Wii video game system that utilizes a balance board peripheral. The subject stands on the balance board and engages in video games that require weight shifting and balancing in order to interact with the game. This intervention will be administered for 30 minutes, 3 to 5 times per week (as tolerated by subject), for a two week period. | Procedure or surgery | All participants |
| Traditional balance trainingThis physical therapy intervention involves gait training, balance education on various surfaces, activities involving limited and changing bases of support, and dynamic interaction with the subject's environment. This intervention will be administered 30 minutes per day, 3 to 5 days per week (by subject's tolerance), for a two week period. | Procedure or surgery | All participants |
Primary outcome
WiiFit
Time frame: Before and after two consecutive 2 week periods: one period without intervention, one with
For standing balance we will be using the Berg Balance Scale and Single Leg Stance. The investigators will also be looking at weight bearing symmetry utilizing the intrinsic tests included with the Nintendo Wii Fit ™ Measurements will be taken at baseline (pre-intervention), and at conclusion of each intervention phase (after 2 weeks of traditional balance therapy and then again after 2 weeks of training using the Nintendo Wii Fit ™)
1 secondary outcome
Satisfaction
Time frame: Post Intervention (at conclusion of two 2 week trials)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Geoffrey D. Mosley, PT principal investigator
Missouri Rehabilitation Center, University of Missouri Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii Fit and Traditional balance training in people with Distorted; Balance, run by University of Missouri-Columbia 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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 Sep 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
WiiFit (time frame: Before and after two consecutive 2 week periods: one period without intervention, one with). 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 30 Sep 2016.