The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy

October 25, 2016 updated by: David Pothier, University Health Network, Toronto
Patients with a unilateral vestibular loss often complain of dizziness and imbalance. Movement usually increases these symptoms often resulting in patients avoiding these movements, causing further limitations in their activities of daily living. Vestibular Rehabilitation (VR) involves a series of adaptation and balance exercises to improve symptoms of postural stability. There is evidence that stroke patients gain benefit in their rehabilitation from using gaming consoles (Nintendo Wii Balance) and we believe that similar advantages can be shown for balance patients. We plan a 3 arm study. As there is a considerable wait list for VR, the first arm will receive a Wii console and instructions to use it on the wait list and during VR. The second arm will receive a Wii console and instructions at the end of the waiting list and will use it during VR only and the control group will receive no Wii. All will spend the same time on the wait list and will receive identical assessments and VR

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

None required

Study Type

Interventional

Enrollment (Actual)

7

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral vestibular loss
  • Uncompensated
  • Present for >6 months

Exclusion Criteria:

  • Age <18 years

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No Wii balance gaming undertaken
Active Comparator: Wii during vestibular rehab only
To start Wii Balance Gaming from the beginning of vestibular rehabilitation.
Other: Use of Nintendo Wii Balance Gaming system
Use of Nintendo Wii Balance Gaming system
Other Names:
  • Nintendo, Wii, Balance Board, Wii Fit
Active Comparator: Wii whilst on waiting list and rehab
Wii Balance Gaming whilst on waiting list for vestibular rehabilitation. To continue with Wii Balance Gaming until end of vestibular rehabilitation.
Other: Use of Nintendo Wii Balance Gaming system
Use of Nintendo Wii Balance Gaming system
Other Names:
  • Nintendo, Wii, Balance Board, Wii Fit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Index
Time Frame: t=0 (at initial assessment)

Dynamic Gait index assessed by questionnaire at initial assessment (t=0) and then at 6 (midway through wait list), 12 (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)

All groups compared at baseline
t=0 (at initial assessment)
Dizziness Handicap Index
Time Frame: t=6 weeks

Dynamic Gait index assessed by questionnaire at initial assessment (t=0) and then at 6 (midway through wait list), 12 (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)

Group 1 (Wii during wait list and Vestibular Rehab) compared to Group 3 (Control)
t=6 weeks
Dizziness Handicap Index
Time Frame: t=12 weeks

Dynamic Gait index assessed by questionnaire at initial assessment (t=0) and then at 6 (midway through wait list), 12 (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)

Group 1 (Wii during wait list and Vestibular Rehab) compared to Group 3 (Control)

All groups compared as a baseline before Vestibular Rehab
t=12 weeks
Dizziness Handicap Index
Time Frame: t=18 weeks

Dynamic Gait index assessed by questionnaire at initial assessment (t=0) and then at 6 (midway through wait list), 12 (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)

Group 2 (Wii during Vestibular Rehab only) compared to Group 3 (Control)
t=18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Clinical Test of Sensory Interaction on Balance
Time Frame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
mCTSIB assessed by blinded assessor at initial assessment (t=0)and then at 12 (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)
t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Activity Specific Balance Confidence Scale
Time Frame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Activity Specific Balance Confidence Scale assessed by questionnaire at initial assessment (t=0)and then at 6 (midway through wait list), 12 (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)
t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Dynamic Gait Index score
Time Frame: t=0 (at initial assessment), t=12 weeks, t=18 weeks
Dynamic Gait index assessed by blinded assessor at initial assessment (t=0)and then at 12 weeks (beginning of vestibular rehabilitation) and 18 weeks (end of vestibular rehabilitation)
t=0 (at initial assessment), t=12 weeks, t=18 weeks

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: John A Rutka, MD FRCS(C), Toronto General Hospital

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

March 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN-TGH-NO-0004

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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