Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570178
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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 Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
No Intervention: standard practice advice
standard practice advice
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of falls [ Time Frame: Change from baseline in number of falls at 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Spain
Jordi Gol Gurina Foundation
Barcelona, Catalonia, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Layout table for investigator information
Principal Investigator: Pilar Montero, MD Catalan Health System

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02570178     History of Changes
Other Study ID Numbers: PI12/01677
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Keywords provided by Jordi Gol i Gurina Foundation:
clinical trial
accidental falls
postural balance
elderly
primary Health Care