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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,037
- Locations
- 2
- Primary Endpoint
- Balance calculated by the Tinetti test
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Balance calculated by the Tinetti test
Time Frame: change from baseline in Tinetti Test at 3 and 12 months
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)
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
Balance calculated by the one footed stationary test
Time Frame: change from baseline in one footed stationary test at 3 and 12 months
Secondary Outcomes
- Number of falls(Change from baseline in number of falls at 12 months)