NCT01229969

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

October 27, 2010

Last Update Submit

January 23, 2013

Conditions

Keywords

falls, balance problems, gaming systems, balance assessments

Outcome Measures

Primary Outcomes (1)

  • Feasibility and validity of the Wii Fit gaming system in detect balance problems in older adults

    8 weeks

Study Arms (2)

NeuroCom EquiTest® System

EXPERIMENTAL

Measure balance assessment (test for Sensory Organization Test (SOT) and Limit of Stability (LOS).

Other: NeuroCom EquiTest® System

Wii Fit

EXPERIMENTAL

Determine if the Wii Fit is valid and feasible in detecting balance problems in older adults

Other: Wii Fit Balance Games

Interventions

Ski Slaloms and Table Tilt

Also known as: Ski Slaloms and Table Tilt
Wii Fit

Sensory Organization Test (SOT) and Limit of Stability (LOS).

Also known as: SOT and LOS
NeuroCom EquiTest® System

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants 60 years of age or older
  • Reside in the community
  • Who are with and without balance or gait issues

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Study Officials

  • Theodore M Johnson, MD,MPH

    Atlanta Veteran Affairs Adminstration, Emory University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Site Director, Birmingham/Atlanta VA GRECC

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 28, 2010

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations