Impaired BalanceWIICANNCT01371253
10 Weeks of NIntendo wIi Fit balanCe Training Improved Postural balANce and Muscle Strength in Elderly Individuals
A study testing Nintendo wii balance training and EVA-soles in people with Impaired Balance, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is required. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Impaired Balance
- What is being tested?
- Nintendo wii balance training and EVA-soles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Oct 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age above 65 years
- No physical therapy during the previous month
- capable of understanding instructions
- not recovering from acute illness
- minimal loss of visual acuity
- Selfprecived balance (good, average, poor) = average or poor
- No orthopaedic Surgery within the last 6 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 10 Weeks of NIntendo wIi Fit balanCe Training Improved Postural balANce and Muscle Strength in Elderly Individuals: Double Blinded, Randomised Controlled Trial
On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is required. The cost of these admissions vary according to the type of injury with hip fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total average cost of a severe hip fracture in the Danish healthcare system resulting in nursing home placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year {{288 Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who sustain a hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the outcome of falling in the elderly population is therefore not only associated with severe human but also economical consequences. Hence, it is essential to refine, develop and think "out of the box" when future intervention programs are designed and employed in the elderly community.
One such "out of the box" intervention could be balance training with a Nintendo Wii Fit board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is a new generation of computer game which uses 3D tracking of the participants' motion and gestures. This means that the user interacts in and controls elements of the 3D gaming world with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it detects the body sway and center of pressure (COP) of the participant and displays it onto a TV screen in different balance sceneries. A virtual character on the TV then reacts according to the user's movement and gesture (ex. skiing down a ski slope passing thru gates). This enables the user to perform tasks that, they may not be able to execute safely or at all in real-world situations. Interestingly in this context a study by Sihvonen et al from 2004 showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D and with a poor graphical display. Further, the Sihvonen-study showed that 2D "biofeedback" intervention of only 4 weeks proved successful in terms of improved postural balance, physical activity and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods when promoting physical activity in the elderly population has been limited by lack of motivation or poor compliance (REFS), which possibly has prevented the elderly from reaching a maximum rehabilitation potential(REFS). Furthermore, in the follow-up period after these traditional intervention studies, it has been documented how difficult it is for the elderly to sustain the same training volume on themselves (REFS).
Read more
Virtual reality systems like the Nintendo Wii Fit have been developed specifically for rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L. 2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion, speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these systems have not become commercially available possible due to a very high cost {{294 Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to be constructed from scratch making the hole process and implication very complicated {{306 Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost ready-to-use Wii Fit platform could be a possible research direction to explore. At the moment few studies have been conducted using the Nintendo Wii console. Among the few some have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294 Deutsch,J.E. 2008; }}.
To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii Fit balance training in seniors (+65 years). The main purpose of the study is to investigate the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors (+65 years of age) have a significant effect on postural balance and muscle strength.
- Conditions
- Impaired Balance
- Being tested
- Nintendo wii balance training, EVA-soles
- Keywords
- Nintendo wii, postural balance, muscle strength, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo wii balance trainingOther
EVA-solesOther
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Wii traning | Experimental | Balance training Receives: Other: Nintendo wii balance training |
| EVA-soles | Placebo comparator | Not described Receives: Other: EVA-soles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
M-L sway velocity, A-P sway velocity and velocity moment on a Metitur, FI " Good Balance"
Measured: Baseline=june; Endline=september
Muscle strength
Maximum muscle strength (MVC) and rate of force development (RFD) bilateral assessed on a Newtest,FI legpress
Measured: Baseline=june; Endline=september
Motivation
At the end of the study 3 questions on the likert scale will be asked in order to evaluate the participants motivation for further nintendo wii training.
Measured: Baseline=june; Endline=september
Secondary outcomes (2)
Fear of falling
Fear of falling will be assessed using the FES-I (short)
Measured: Baseline=june; Endline=september
Timed up and go
The TUG test
Measured: Baseline=june; Endline=september
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired BalanceStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Joergensen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371253
- Sponsor's protocol ID
- Wii1
- Acronym
- WIICAN
- Status last verified
- Jan 2012
- First submitted
- 9 Jun 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.
PubMed 23114461
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Weeks of NIntendo wIi Fit balanCe Training Improved Postural balANce and Muscle Strength in Elderly Individuals: Double Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01371253
- Acronym / sponsor ID
- WIICAN / Wii1
- Conditions
- Impaired Balance
- Keywords
- Nintendo wii, postural balance, muscle strength, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Jun 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.
On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is required. The cost of these admissions vary according to the type of injury with hip fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total average cost of a severe hip fracture in the Danish healthcare system resulting in nursing home placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year {{288 Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who sustain a hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the outcome of falling in the elderly population is therefore not only associated with severe human but also economical consequences. Hence, it is essential to refine, develop and think "out of the box" when future intervention programs are designed and employed in the elderly community.
One such "out of the box" intervention could be balance training with a Nintendo Wii Fit board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is a new generation of computer game which uses 3D tracking of the participants' motion and gestures. This means that the user interacts in and controls elements of the 3D gaming world with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it detects the body sway and center of pressure (COP) of the participant and displays it onto a TV screen in different balance sceneries. A virtual character on the TV then reacts according to the user's movement and gesture (ex. skiing down a ski slope passing thru gates). This enables the user to perform tasks that, they may not be able to execute safely or at all in real-world situations. Interestingly in this context a study by Sihvonen et al from 2004 showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D and with a poor graphical display. Further, the Sihvonen-study showed that 2D "biofeedback" intervention of only 4 weeks proved successful in terms of improved postural balance, physical activity and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods when promoting physical activity in the elderly population has been limited by lack of motivation or poor compliance (REFS), which possibly has prevented the elderly from reaching a maximum rehabilitation potential(REFS). Furthermore, in the follow-up period after these traditional intervention studies, it has been documented how difficult it is for the elderly to sustain the same training volume on themselves (REFS).
Virtual reality systems like the Nintendo Wii Fit have been developed specifically for rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L. 2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion, speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these systems have not become commercially available possible due to a very high cost {{294 Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to be constructed from scratch making the hole process and implication very complicated {{306 Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost ready-to-use Wii Fit platform could be a possible research direction to explore. At the moment few studies have been conducted using the Nintendo Wii console. Among the few some have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294 Deutsch,J.E. 2008; }}.
To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii Fit balance training in seniors (+65 years). The main purpose of the study is to investigate the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors (+65 years of age) have a significant effect on postural balance and muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii traning | Experimental | Other: Nintendo wii balance trainingBalance training |
| EVA-soles | Placebo comparator | Other: EVA-soles |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age above 65 years
- No physical therapy during the previous month
- capable of understanding instructions
- not recovering from acute illness
- minimal loss of visual acuity
Key exclusion criteria (0 listed)
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 balance training | Other | Nintendo Wii traning |
| EVA-soles | Other | EVA-soles |
Primary outcome
Balance
Time frame: Baseline=june; Endline=september
M-L sway velocity, A-P sway velocity and velocity moment on a Metitur, FI " Good Balance"
Muscle strength
Time frame: Baseline=june; Endline=september
Maximum muscle strength (MVC) and rate of force development (RFD) bilateral assessed on a Newtest,FI legpress
Motivation
Time frame: Baseline=june; Endline=september
At the end of the study 3 questions on the likert scale will be asked in order to evaluate the participants motivation for further nintendo wii training.
2 secondary outcomes
Fear of falling
Time frame: Baseline=june; Endline=september
Timed up and go
Time frame: Baseline=june; Endline=september
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 19 Jan 2012.
- Derived from this study: PubMed 23114461Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 balance training and EVA-soles in people with Impaired Balance, run by Aalborg University Hospital at 1 site in Denmark.
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 0 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 19 Jan 2012. 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 Denmark. 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 (time frame: Baseline=june; Endline=september). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371253, which also lists 1 linked publication.
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 19 Jan 2012.