Skip to main content
OpenTrials
Completed

NCT Number: NCT02570178

Effectiveness of an Intervention 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postural Balance Accidental Falls Intervention Studies

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordi Gol Gurina Foundation

Barcelona, Catalonia, 08007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance training

Other

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.

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

    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)

Secondary outcomes

  1. Number of falls

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

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study 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)

Acronym: EWii

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.