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

Primary Purpose

Vestibular Diseases, Disturbance; Balance, Labyrinth

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Use of Nintendo Wii Balance Gaming system
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Diseases focused on measuring Balance, Rehabilitation, Vestibular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Wii during vestibular rehab only

Wii whilst on waiting list and rehab

Arm Description

No Wii balance gaming undertaken

To start Wii Balance Gaming from the beginning of vestibular rehabilitation.

Wii Balance Gaming whilst on waiting list for vestibular rehabilitation. To continue with Wii Balance Gaming until end of vestibular rehabilitation.

Outcomes

Primary Outcome Measures

Dizziness Handicap Index
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
Dizziness Handicap Index
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)
Dizziness Handicap Index
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
Dizziness Handicap Index
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)

Secondary Outcome Measures

Modified Clinical Test of Sensory Interaction on Balance
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)
Activity Specific Balance Confidence Scale
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)
Dynamic Gait Index score
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)

Full Information

First Posted
February 16, 2011
Last Updated
October 25, 2016
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01305278
Brief Title
The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
Official Title
The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
We unfortunately experienced recruitment difficulties with this study for the past few years.
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
None required

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases, Disturbance; Balance, Labyrinth
Keywords
Balance, Rehabilitation, Vestibular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No Wii balance gaming undertaken
Arm Title
Wii during vestibular rehab only
Arm Type
Active Comparator
Arm Description
To start Wii Balance Gaming from the beginning of vestibular rehabilitation.
Arm Title
Wii whilst on waiting list and rehab
Arm Type
Active Comparator
Arm Description
Wii Balance Gaming whilst on waiting list for vestibular rehabilitation. To continue with Wii Balance Gaming until end of vestibular rehabilitation.
Intervention Type
Other
Intervention Name(s)
Use of Nintendo Wii Balance Gaming system
Other Intervention Name(s)
Nintendo, Wii, Balance Board, Wii Fit
Intervention Description
Use of Nintendo Wii Balance Gaming system
Primary Outcome Measure Information:
Title
Dizziness Handicap Index
Description
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
Time Frame
t=0 (at initial assessment)
Title
Dizziness Handicap Index
Description
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)
Time Frame
t=6 weeks
Title
Dizziness Handicap Index
Description
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
Time Frame
t=12 weeks
Title
Dizziness Handicap Index
Description
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)
Time Frame
t=18 weeks
Secondary Outcome Measure Information:
Title
Modified Clinical Test of Sensory Interaction on Balance
Description
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)
Time Frame
t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Title
Activity Specific Balance Confidence Scale
Description
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)
Time Frame
t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Title
Dynamic Gait Index score
Description
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)
Time Frame
t=0 (at initial assessment), t=12 weeks, t=18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral vestibular loss Uncompensated Present for >6 months Exclusion Criteria: Age <18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Rutka, MD FRCS(C)
Organizational Affiliation
Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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

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