A Pilot Study of the Wii Fit as a Low-Cost Virtual Reality System to Evaluate Balance Ability in Older Adults (WiiFit)

January 23, 2013 updated by: Theodore Johnson II, M.D., M.P.H., Atlanta VA Medical Center
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite of exercise and fitness video games using a balance board periphery developed for the Wii console. The purpose of this study is to determine the feasibility and validity of the Nintendo Wii Fit, in detecting balance problems in older community dwelling adults.20 ambulatory older adults will be recruited to participate in this study.Subject will be asked to complete 1 study visit. In this visit information will be gathered about the subjects overall health including fall assessments. Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order.

Study Overview

Detailed Description

Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. Falls are also costly. An estimate $20 billion dollars annually has been spent on hip fractures associated with falls; this amount is projected to rise in the next decade. Risk factors for falls in the elderly are usually multi-factorial. These include increasing age, environmental factors, acute or chronic illness, medication use, cognitive impairment, sensory deficits, and balance and gait impairment.

The Nintendo Wii Fit system is engaging, low-cost, and standardized and may be a feasible exercise modality to improve balance in the elderly. While virtual reality use in a research context is not new, few studies of commercially available low-cost video games with virtual reality capabilities have been done. These have demonstrated encouraging results, indicating a potential use for rehabilitation in both children and adults.

Twenty ambulatory older individuals age 60 and older who reside in the community will be recruited to participate in this study.This group of participants will be selected to represent the general community dwelling older adults as much as possible. They will demonstrate a wide range of ability in terms of their balance and mobility in which some are healthy (non-fallers), some with risks of falling, and some fallers. Efforts will be made to have equal distribution among these three groups.

Subjects will be consented for the research study and we will ask questions about age, gender, educational background, medical history, and any falls in past year. They will also be evaluated clinically before the actual study to assess vision, cognitive status, and balance.

Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order. This counterbalancing between subjects is designed to negate any potential order effect. Balance data collected from the NeuroCom EquiTest will be compared to the performance scores obtained from playing the two Wii Fit balance games to determine whether the performance scores on the two Wii Fit balance games are indicative of the participants' balance ability.All study interventions are completed in a 1 day session.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants 60 years of age or older
  2. Reside in the community
  3. Who are with and without balance or gait issues

Exclusion Criteria:

  1. Impaired mental status, patient scores <21 on Montreal Cognitive Assessment (MoCA)
  2. Unable to ambulate without an assistive walking device
  3. Cannot stand independently for 20 minutes of testing over a 30min period
  4. Unstable medical conditions

    1. Active cardiopulmonary
    2. Degenerative neuro-sensory conditions
    3. Severe pain with weight bearing
  5. Vision Impairment
  6. Weighing more than 300 pounds (150kg)
  7. Used Wii Fit equipment in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NeuroCom EquiTest® System
Measure balance assessment (test for Sensory Organization Test (SOT) and Limit of Stability (LOS).
Sensory Organization Test (SOT) and Limit of Stability (LOS).
Other Names:
  • SOT and LOS
EXPERIMENTAL: Wii Fit
Determine if the Wii Fit is valid and feasible in detecting balance problems in older adults
Ski Slaloms and Table Tilt
Other Names:
  • Ski Slaloms and Table Tilt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility and validity of the Wii Fit gaming system in detect balance problems in older adults
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Theodore M Johnson, MD,MPH, Atlanta Veteran Affairs Adminstration, Emory University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (ESTIMATE)

October 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2009-060390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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