Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii) (EWii)
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|ClinicalTrials.gov Identifier: NCT02570178|
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postural Balance Accidental Falls Intervention Studies||Other: balance training||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1037 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
No Intervention: standard practice advice
standard practice advice
balance training using the Nintendo™ Wii console and its balance board.
Other: balance 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.
- 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)
- Number of falls [ Time Frame: Change from baseline in number of falls at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570178
|Jordi Gol Gurina Foundation|
|Barcelona, Catalonia, Spain, 08007|
|Principal Investigator:||Pilar Montero, MD||Catalan Health System|