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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01082042
Other study ID # BGS05/2008
Secondary ID
Status Completed
Phase N/A
First received March 4, 2010
Last updated March 4, 2010
Start date January 2009
Est. completion date June 2009

Study information

Verified date June 2009
Source NHS Grampian
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable to a physiotherapist−led falls group in terms of improvement in balance. The acceptability of the Nintendo® Wii will also be assessed.


Description:

The population is ageing and as a result medical staff and allied health professionals are likely to see an increase in the number of patients with falls. Community dwelling individuals over 65 fall at a rate of 30% per year. This risk increases with advancing age. Falls have significant consequences for both the individual and the population as a whole. Falls risk increases with age due to increased body sway, a reduction in reaction times, deterioration in the efficiency of the walking pattern and diminished balance.

People who fall should be referred for multidisciplinary falls assessment. Locally, patients are assessed by the multidisciplinary team and, if appropriate, attend falls group. This group consists of a 12 week exercise program to improve balance and muscle strength (patients attend the group up to 3 times weekly). Previously trials have shown variable compliance with exercise programs but locally compliance is felt to be good. Falls groups aim to reduce falls through the benefits of exercise; improvement in muscle strength,balance, general fitness and well being. It has been shown that exercise has statistically significant beneficial effects on balance.

Due to advances in technology, equipment has been produced to improve balance on both the medical and commercial market. There is a large variability in cost between this equipment with commercial prices being much lower. The Wii has been very successful in encouraging sedentary youths to partake in exercise (all be it in a limited form). WiiFit is a specifically designed "game" for the Wii to improve balance with an element of entertainment value.

This project is important due the large number of falls that occur in the community and the significant impact this has on an under resourced NHS. It is timely because the WiiFit has only just been introduced into the market. Through the use of a Wii, balance training may be more enjoyable and as a result elderly community dwellers may be more likely to participate in exercise programmes. The Wii is considerably cheaper than the medical alternatives and if an improvement can be shown in post−intervention balance assessments, then we have to consider whether the use of similar equipment should be instituted in falls groups.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- age 70 years or older

- living locally in the community (in either sheltered accommodation or own home

- fallen at least once in the preceding 12 months

- abbreviated mental test (AMT) of seven or over

Exclusion Criteria:

- wheelchair bound

- people living in a care home or long-term hospital care.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Department of Medicine for the Elderly, Woodend Hospital Aberdeen Aberdeenshire

Sponsors (2)

Lead Sponsor Collaborator
NHS Grampian British Geriatrics Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in formal balance score Berg and Tinetti balance scores 4 weeks and 12 weeks following the exercise intervention No
Secondary Acceptability of the Nintendo WiiFit in community-dwelling older fallers Individual interview and completion of the Attitudes to Falls-Related Interventions Scale (AFRIS) 12 weeks No
Secondary Participants degree of concern about falling in certain situations following the intervention Falls Efficacy Scale - International (FES-I) 4 weeks and 12 weeks No
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