- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229969
A Pilot Study of the Wii Fit as a Low-Cost Virtual Reality System to Evaluate Balance Ability in Older Adults (WiiFit)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants 60 years of age or older
- Reside in the community
- Who are with and without balance or gait issues
Exclusion Criteria:
- Impaired mental status, patient scores <21 on Montreal Cognitive Assessment (MoCA)
- Unable to ambulate without an assistive walking device
- Cannot stand independently for 20 minutes of testing over a 30min period
Unstable medical conditions
- Active cardiopulmonary
- Degenerative neuro-sensory conditions
- Severe pain with weight bearing
- Vision Impairment
- Weighing more than 300 pounds (150kg)
- Used Wii Fit equipment in the past
Study Plan
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).
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Sensory Organization Test (SOT) and Limit of Stability (LOS).
Other Names:
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EXPERIMENTAL: Wii Fit
Determine if the Wii Fit is valid and feasible in detecting balance problems in older adults
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Ski Slaloms and Table Tilt
Other Names:
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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
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8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Theodore M Johnson, MD,MPH, Atlanta Veteran Affairs Adminstration, Emory University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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