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CompletedNCT02570178EWiiUpdated Mar 22, 2017

Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii)

An interventional study of balance training in Postural Balance, Accidental Falls and Intervention Studies, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,037
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Postural Balance
  • Accidental Falls
  • Intervention Studies

Keywords

  • clinical trial
  • accidental falls
  • postural balance
  • elderly
  • primary Health Care
03

In context

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
1,037 participants (actual)

Study arms

  • No intervention
    standard practice advice

    standard practice advice

  • Other
    balance training

    balance training using the Nintendo™ Wii console and its balance board.

    Other: balance training

Interventions

  • Otherbalance training

    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.

06

What researchers measure

Primary outcomes

  1. Balance calculated by the Tinetti test

    Time frame: change from baseline in Tinetti Test at 3 and 12 months

  2. Balance calculated by the one footed stationary test

    Time frame: change from baseline in one footed stationary test at 3 and 12 months

  3. 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

  4. 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)

    Time frame: change from baseline in FES-I at 3 and 12 months

Secondary outcomes

  1. Number of falls

    Time frame: Change from baseline in number of falls at 12 months

07

Study locations

1 site
  • Jordi Gol Gurina Foundation
    Barcelona, Catalonia 08007, Spain
08

References and documents

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 22972103 ↗
  • Williams 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 20831836 ↗
  • Lister 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 25654660 ↗
  • Montero-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 31081504 ↗
  • Montero-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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02570178
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible party
Sponsor
First posted
Oct 7, 2015
Start date
Sep 2012
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 22, 2017

Study contacts

Pilar Montero, MD
principal investigator · Catalan Health System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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