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

Vestibular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01305278
• Other study ID #: UHN-TGH-NO-0004
• Status: Terminated
• Phase: N/A
• First received: February 16, 2011
• Last updated: October 25, 2016
• Start date: March 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Description:

None required

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unilateral vestibular loss

• Uncompensated

• Present for >6 months

Exclusion Criteria:

• Age <18 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disturbance; Balance, Labyrinth
• Vestibular Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No