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

Accidental Falls Clinical Trial

— EWii  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570178
• Other study ID #: PI12/01677
• Status: Completed
• Phase: N/A
• First received: July 2, 2015
• Last updated: March 21, 2017
• Start date: September 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 obtained in the Tinetti tests and the one foot stationary test.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1037
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Accidental Falls
• Intervention Studies
• Postural Balance

Intervention

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.

Locations

Country	Name	City	State
Spain	Jordi Gol Gurina Foundation	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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;(9):CD007146. doi: 10.1002/14651858.CD007146.pub3. Review. — View Citation

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. — View Citation

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® WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance calculated by the Tinetti test		change from baseline in Tinetti Test at 3 and 12 months
Primary	Balance calculated by the one footed stationary test		change from baseline in one footed stationary test at 3 and 12 months
Primary	Percentage of balance calculated by the NintendoTM Wii console		change from baseline in Percentage of balance calculated by the NintendoTM Wii console at 3 and 12 months
Primary	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)	change from baseline in FES-I at 3 and 12 months
Secondary	Number of falls		Change from baseline in number of falls at 12 months

External Links

•   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 balance