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

Study Overview
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Brief Summary
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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
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None required

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

Conditions
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Vestibular Diseases, Disturbance; Balance, Labyrinth

Intervention / Treatment
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* Other: Use of Nintendo Wii Balance Gaming system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral vestibular loss Uncompensated Present for >6 months Exclusion Criteria: Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No Wii balance gaming undertaken | |
| Active Comparator: Wii during vestibular rehab only<br>To start Wii Balance Gaming from the beginning of vestibular rehabilitation. | Other: Use of Nintendo Wii Balance Gaming system<br>* Use of Nintendo Wii Balance Gaming system<br>* Other names: Nintendo, Wii, Balance Board, Wii Fit;|
| Active Comparator: Wii whilst on waiting list and rehab<br>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<br>* Use of Nintendo Wii Balance Gaming system<br>* Other names: Nintendo, Wii, Balance Board, Wii Fit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | t=0 (at initial assessment) | 
| 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) | t=6 weeks | 
| 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 | t=12 weeks | 
| 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) | t=18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks | 
| 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) | t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks | 
| 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) | t=0 (at initial assessment), t=12 weeks, t=18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Rehabilitation, Vestibular