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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
David Pothier, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01305278
First received: February 16, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Vestibular Diseases
Disturbance; Balance, Labyrinth
Other: Use of Nintendo Wii Balance Gaming system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Dizziness Handicap Index [ Time Frame: t=0 (at initial assessment) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 45
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Nintendo, Wii, Balance Board, Wii Fit

Detailed Description:

None required

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305278

Contacts
Contact: David D Pothier, MBChB FRCS 416 340 4630 david.pothier@uhn.on.ca
Contact: Wanda Dillon, RN 416 340 5226 wanda.dillon@uhn.on.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Wanda Dillon, RN    416 340 5226    wanda.dillon@uhn.on.ca   
Sub-Investigator: David D Pothier, MBChB FRCS         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John A Rutka, MD FRCS(C) Toronto General Hospital
  More Information

No publications provided

Responsible Party: David Pothier, Assistant Professor, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01305278     History of Changes
Other Study ID Numbers: UHN-TGH-NO-0004
Study First Received: February 16, 2011
Last Updated: September 9, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Balance
Rehabilitation
Vestibular

Additional relevant MeSH terms:
Vestibular Diseases
Ear Diseases
Labyrinth Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014