Postural BalanceEWiiNCT02570178
Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii)
A study testing balance training in people with Postural Balance and Accidental Falls, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Accidental Falls, Intervention Studies
- What is being tested?
- balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,037 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Dec 2016
- 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
- Individuals aged 70 or older, of both genders,
- with the ability to walk, with or without technical assistance
- who are available for a one year period and who agree to participate in the study, signing an informed consent form
Who cannot join
- Home-bound patients
- individuals who are already receiving rehabilitation treatment on walking
- those with moderate cognitive deterioration (Pfeiffer ≥5)
- terminally ill patients
- individuals who do not have a telephone
- those with communication difficulties: cognitive and/or sensory deterioration, language barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Evaluating the Effectiveness of a Primary Care Intervention Using the NintendoTM Wii Console to Improve Balance and Decrease Falls in the Elderly (EWii)
The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.
Read the detailed description
Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.
Methods/Design: This is a controlled, randomized clinical trial of individual assignment, carried out on patients over 70 years in age, from five primary care centers in the city of Mataró (Barcelona). 380 patients were necessary for the intervention group that carried out the balance board exercises in 2 sessions per week for a 3 month period, and 380 patients in the control group who carried out their usual habits. Balance was evaluated using the Tinetti test, the one foot stationary test and with the console, at the start of the study, at the end of the intervention (3 months) and one year later. Quarterly telephone follow-up was also conducted to keep track of falls and their consequences.
Discussion: The study aimed to connect the community with a technology that may be an easy and fun way to assist the elderly in improving their balance without the need to leave home or join rehabilitation groups, offering greater comfort for this population and decreasing healthcare costs since there is no need for specialized personnel.
- Conditions
- Postural Balance, Accidental Falls, Intervention Studies
- Being tested
- balance training
- Keywords
- clinical trial, accidental falls, postural balance, elderly, primary Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance trainingOther
Participants complete 2 sessions per week for 30 minutes each, over a period of three months and are distributed in groups of four individuals carrying out the exercises at once.The groups were led by monitors who had received standardized training. Each participant was barefoot on the balance board, carrying out the different exercises in the balance area of the Wii Fit™ game, according to the indications made on the screen.Eight out of the nine balance exercises were used from the Wii Fit™ game (balance bubble, soccer heading, ski jump, table tilt, ski slalom, penguin slide, snowboard slalom, tightrope walk);.The number of repetitions of each exercise varied depending on the skill of the participants but the total time dedicated to each exercise was the same for all group participants.
| Study group | Role | What they receive |
|---|---|---|
| standard practice advice | No intervention | standard practice advice |
| balance training | Other | balance training using the Nintendo™ Wii console and its balance board. Receives: Other: balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance calculated by the Tinetti test
Measured: change from baseline in Tinetti Test at 3 and 12 months
Balance calculated by the one footed stationary test
Measured: change from baseline in one footed stationary test at 3 and 12 months
Percentage of balance calculated by the NintendoTM Wii console
Measured: change from baseline in Percentage of balance calculated by the NintendoTM Wii console at 3 and 12 months
Fear of falling
The Short FES-I (Falls Efficacy Scale) looks at the probability of falling in seven everyday situations. Scoring ranges from 7 to 28 points (high scores indicate a greater fear of falling)
Measured: change from baseline in FES-I at 3 and 12 months
Secondary outcomes (1)
Number of falls
Measured: Change from baseline in number of falls at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startSep 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Montero, MD, Principal investigator, Catalan Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570178
- Sponsor's protocol ID
- PI12/01677
- Acronym
- EWii
- Status last verified
- Mar 2017
- First submitted
- 2 Jul 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
PubMed 22972103Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
PubMed 20831836Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
PubMed 25654660Montero-Alia P, Miralles-Basseda R, Lopez-Jimenez T, Munoz-Ortiz L, Jimenez-Gonzalez M, Prat-Rovira J, Albarran-Sanchez JL, Manresa-Dominguez JM, Andreu-Concha CM, Rodriguez-Perez MC, Marti-Cervantes JJ, Sanudo-Blanco L, Sanchez-Perez CA, Dolader-Olive S, Toran-Monserrat P. Controlled trial of balance training using a video game console in community-dwelling older adults. Age Ageing. 2019 Jul 1;48(4):506-512. doi: 10.1093/ageing/afz047.
PubMed 31081504Montero-Alia P, Munoz-Ortiz L, Jimenez-Gonzalez M, Benedicto-Panell C, Altimir-Losada S, Lopez-Colomer Y, Prat-Rovira J, Amargant-Rubio JF, Jastes SM, Moreno-Buitrago A, Rodriguez-Perez MC, Teixido-Vargas C, Albarran-Sanchez JL, Candel-Gil A, Serra-Serra D, Marti-Cervantes JJ, Sanchez-Perez CA, Sanudo-Blanco L, Dolader-Olive S, Toran-Monserrat P. Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo Wii console to improve balance and decrease falls in the elderly. BMC Geriatr. 2016 Jan 12;16:8. doi: 10.1186/s12877-015-0178-x.
PubMed 26796956
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating the Effectiveness of a Primary Care Intervention Using the NintendoTM Wii Console to Improve Balance and Decrease Falls in the Elderly (EWii)
- ClinicalTrials.gov ID
- NCT02570178
- Acronym / sponsor ID
- EWii / PI12/01677
- Conditions
- Postural Balance, Accidental Falls, Intervention Studies
- Keywords
- clinical trial, accidental falls, postural balance, elderly, primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Oct 2015 (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 objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.
Detailed description
Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.
Methods/Design: This is a controlled, randomized clinical trial of individual assignment, carried out on patients over 70 years in age, from five primary care centers in the city of Mataró (Barcelona). 380 patients were necessary for the intervention group that carried out the balance board exercises in 2 sessions per week for a 3 month period, and 380 patients in the control group who carried out their usual habits. Balance was evaluated using the Tinetti test, the one foot stationary test and with the console, at the start of the study, at the end of the intervention (3 months) and one year later. Quarterly telephone follow-up was also conducted to keep track of falls and their consequences.
Discussion: The study aimed to connect the community with a technology that may be an easy and fun way to assist the elderly in improving their balance without the need to leave home or join rehabilitation groups, offering greater comfort for this population and decreasing healthcare costs since there is no need for specialized personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard practice advice | No intervention | –standard practice advice |
| balance training | Other | Other: balance trainingbalance training using the Nintendo™ Wii console and its balance board. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 70 or older, of both genders,
- with the ability to walk, with or without technical assistance
- who are available for a one year period and who agree to participate in the study, signing an informed consent form
Key exclusion criteria (6 listed)
- Home-bound patients
- individuals who are already receiving rehabilitation treatment on walking
- those with moderate cognitive deterioration (Pfeiffer ≥5)
- terminally ill patients
- individuals who do not have a telephone
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 |
|---|---|---|
| balance trainingParticipants complete 2 sessions per week for 30 minutes each, over a period of three months and are distributed in groups of four individuals carrying out the exercises at once.The groups were led by monitors who had received standardized training. Each participant was barefoot on the balance board, carrying out the different exercises in the balance area of the Wii Fit™ game, according to the indications made on the screen.Eight out of the nine balance exercises were used from the Wii Fit™ game (balance bubble, soccer heading, ski jump, table tilt, ski slalom, penguin slide, snowboard slalom, tightrope walk);.The number of repetitions of each exercise varied depending on the skill of the participants but the total time dedicated to each exercise was the same for all group participants. | Other | balance training |
Primary outcome
Balance calculated by the Tinetti test
Time frame: change from baseline in Tinetti Test at 3 and 12 months
Balance calculated by the one footed stationary test
Time frame: change from baseline in one footed stationary test at 3 and 12 months
Percentage of balance calculated by the NintendoTM Wii console
Time frame: change from baseline in Percentage of balance calculated by the NintendoTM Wii console at 3 and 12 months
Fear of falling
Time frame: change from baseline in FES-I at 3 and 12 months
The Short FES-I (Falls Efficacy Scale) looks at the probability of falling in seven everyday situations. Scoring ranges from 7 to 28 points (high scores indicate a greater fear of falling)
1 secondary outcome
Number of falls
Time frame: Change from baseline in number of falls at 12 months
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 22 Mar 2017.
- Background: PubMed 22972103Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
- Background: PubMed 20831836Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
- Background: PubMed 25654660Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
- Derived from this study: PubMed 31081504Montero-Alia P, Miralles-Basseda R, Lopez-Jimenez T, Munoz-Ortiz L, Jimenez-Gonzalez M, Prat-Rovira J, Albarran-Sanchez JL, Manresa-Dominguez JM, Andreu-Concha CM, Rodriguez-Perez MC, Marti-Cervantes JJ, Sanudo-Blanco L, Sanchez-Perez CA, Dolader-Olive S, Toran-Monserrat P. Controlled trial of balance training using a video game console in community-dwelling older adults. Age Ageing. 2019 Jul 1;48(4):506-512. doi: 10.1093/ageing/afz047.
- Derived from this study: PubMed 26796956Montero-Alia P, Munoz-Ortiz L, Jimenez-Gonzalez M, Benedicto-Panell C, Altimir-Losada S, Lopez-Colomer Y, Prat-Rovira J, Amargant-Rubio JF, Jastes SM, Moreno-Buitrago A, Rodriguez-Perez MC, Teixido-Vargas C, Albarran-Sanchez JL, Candel-Gil A, Serra-Serra D, Marti-Cervantes JJ, Sanchez-Perez CA, Sanudo-Blanco L, Dolader-Olive S, Toran-Monserrat P. Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo Wii console to improve balance and decrease falls in the elderly. BMC Geriatr. 2016 Jan 12;16:8. doi: 10.1186/s12877-015-0178-x.
- Percentage of balance calculated by the NintendoTM Wii console: Conducting the lame duck test which calculated how the center of gravity moves when the individual is on one foot for a maximum of thirty seconds. High percentages indicate good balanceLink provided by the sponsor.
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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.
Pilar Montero, MD principal investigator
Catalan Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance training in people with Postural Balance and Accidental Falls, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 6 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 22 Mar 2017. 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 Spain. 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?
Balance calculated by the Tinetti test (time frame: change from baseline in Tinetti Test at 3 and 12 months). The study lists 4 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 NCT02570178, which also lists 5 linked publications.
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 22 Mar 2017.