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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02570178
Other study ID # PI12/01677
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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