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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2016

Detailed Description

None required

Interventions

  • Other: Use of Nintendo Wii Balance Gaming system
    • Use of Nintendo Wii Balance Gaming system

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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)
  • 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
  • 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)

Secondary Measures

  • 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)
  • 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)
  • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • Unilateral vestibular loss – Uncompensated – Present for >6 months Exclusion Criteria:

  • Age <18 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Pothier, Assistant Professor – University Health Network, Toronto
  • Overall Official(s)
    • John A Rutka, MD FRCS(C), Principal Investigator, Toronto General Hospital

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