The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
Recruitment status was Not yet recruiting
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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 |
- 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)
- 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 2012 |
| Estimated Primary Completion Date: | March 2012 (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 |
Inclusion Criteria:
- Unilateral vestibular loss
- Uncompensated
- Present for >6 months
Exclusion Criteria:
- Age <18 years
Contacts and Locations| 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 |
| Canada, Ontario | |
| Toronto General Hospital | Not yet 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 | |
| Principal Investigator: | John A Rutka, MD FRCS(C) | Toronto General Hospital |
More Information
No publications provided
| Responsible Party: | Dr John Rutka, University Health Network |
| ClinicalTrials.gov Identifier: | NCT01305278 History of Changes |
| Other Study ID Numbers: | UHN-TGH-NO-0004 |
| Study First Received: | February 16, 2011 |
| Last Updated: | February 24, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Balance Rehabilitation Vestibular |
Additional relevant MeSH terms:
|
Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013