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

Sponsor

Jordi Gol i Gurina Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT02570178

Collaborator

(none)

1,037

Enrollment

Location

Arms

Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postural Balance Accidental Falls Intervention Studies	Other: balance training	N/A

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

Study Type:

Interventional

Actual Enrollment :

1037 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

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 :

Sep 1, 2012

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Balance calculated by the Tinetti test [change from baseline in Tinetti Test at 3 and 12 months]
Balance calculated by the one footed stationary test [change from baseline in one footed stationary test at 3 and 12 months]
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]
Fear of falling [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)

Secondary Outcome Measures

Number of falls [Change from baseline in number of falls at 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

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:

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