NCT01438671

Brief Summary

Our hypothesis is the investigators will find a significant advantage for the use of a virtual reality system like the Wii Fit to improve overall balance scores versus the use of traditional balance activities alone. The objectives will be to determine the enjoyment of these types of gaming activities through the use of a survey to support the hypothesis that these activities are more enjoyable than traditional activities and to gather evidence to support the use of these more enjoyable activities as a viable and needed addition to the overall balance regimen given in the plan of care for a patient with traumatic or acquired brain injury, stroke or spinal cord injury.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

3.1 years

First QC Date

August 2, 2011

Last Update Submit

September 29, 2016

Conditions

Keywords

WiiFitStanding BalanceNeurological Population

Outcome Measures

Primary Outcomes (1)

  • WiiFit

    For standing balance we will be using the Berg Balance Scale and Single Leg Stance. The investigators will also be looking at weight bearing symmetry utilizing the intrinsic tests included with the Nintendo Wii Fit ™ Measurements will be taken at baseline (pre-intervention), and at conclusion of each intervention phase (after 2 weeks of traditional balance therapy and then again after 2 weeks of training using the Nintendo Wii Fit ™)

    Before and after two consecutive 2 week periods: one period without intervention, one with

Secondary Outcomes (1)

  • Satisfaction

    Post Intervention (at conclusion of two 2 week trials)

Study Arms (1)

All participants

EXPERIMENTAL

Nintendo Wii Fit Balance training followed by traditional balance training

Procedure: Nintendo Wii FitProcedure: Traditional balance training

Interventions

The Nintendo Wii Fit is an accessory for the Nintendo Wii video game system that utilizes a balance board peripheral. The subject stands on the balance board and engages in video games that require weight shifting and balancing in order to interact with the game. This intervention will be administered for 30 minutes, 3 to 5 times per week (as tolerated by subject), for a two week period.

All participants

This physical therapy intervention involves gait training, balance education on various surfaces, activities involving limited and changing bases of support, and dynamic interaction with the subject's environment. This intervention will be administered 30 minutes per day, 3 to 5 days per week (by subject's tolerance), for a two week period.

All participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acquired neurological diagnosis
  • years of age or greater
  • Score greater than or equal to an 18 on the MME and/or have a FIM score of 5 in comprehension and problem solving.
  • Ability to stand with no greater than minimal assist (FIM score of 4, less than or equal to 25% assist)
  • Vision that is WFL with or without glasses/contacts
  • Ability to stand for at least 5 minutes without rest.
  • Have at least a WBAT status

You may not qualify if:

  • Person that is less than 18 years of age
  • Person scoring less than an 18 on the MME and/or a FIM score of a 4 or lower in comprehension and problem solving.
  • Person with the inability to stand without minimal assist
  • Inability to stand for 5 minutes without rest
  • Impaired vision
  • Weight bearing precautions of 50%WB or NWB on either lower extremity
  • Any vestibular diagnoses
  • Pain that limits participation
  • Uncontrollable medical complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Missouri Rehabilitation Center

Mount Vernon, Missouri, 65712, United States

Location

Study Officials

  • Geoffrey D. Mosley, PT

    Missouri Rehabilitation Center, University of Missouri Health Systems

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations