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

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Theodore Johnson II, M.D., M.P.H., Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT01229969
First received: October 27, 2010
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Falls, Accidental
Other: Wii Fit Balance Games
Other: NeuroCom EquiTest® System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of the Wii Fit as a Low-Cost Virtual Reality System to Evaluate Balance Ability in Older Adults

Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • Feasibility and validity of the Wii Fit gaming system in detect balance problems in older adults [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2009
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeuroCom EquiTest® System
Measure balance assessment (test for Sensory Organization Test (SOT) and Limit of Stability (LOS).
Other: NeuroCom EquiTest® System
Sensory Organization Test (SOT) and Limit of Stability (LOS).
Other Name: SOT and LOS
Experimental: Wii Fit
Determine if the Wii Fit is valid and feasible in detecting balance problems in older adults
Other: Wii Fit Balance Games
Ski Slaloms and Table Tilt
Other Name: Ski Slaloms and Table Tilt

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229969

Locations
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30033
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
Investigators
Principal Investigator: Theodore M Johnson, MD,MPH Atlanta Veteran Affairs Adminstration, Emory University School of Medicine
  More Information

No publications provided

Responsible Party: Theodore Johnson II, M.D., M.P.H., Site Director, Birmingham/Atlanta VA GRECC, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT01229969     History of Changes
Other Study ID Numbers: 2009-060390
Study First Received: October 27, 2010
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Atlanta VA Medical Center:
falls, balance problems, gaming systems, balance assessments

ClinicalTrials.gov processed this record on October 22, 2014