NCT01305278

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

5.3 years

First QC Date

February 16, 2011

Last Update Submit

October 25, 2016

Conditions

Vestibular DiseasesDisturbance; Balance, Labyrinth

Keywords

BalanceRehabilitationVestibular

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Modified Clinical Test of Sensory Interaction on Balance

    t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks

  • Activity Specific Balance Confidence Scale

    t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks

  • Dynamic Gait Index score

    t=0 (at initial assessment), t=12 weeks, t=18 weeks

Study Arms (3)

Control

NO INTERVENTION

No Wii balance gaming undertaken

Wii during vestibular rehab only

ACTIVE COMPARATOR

To start Wii Balance Gaming from the beginning of vestibular rehabilitation.

Other: Use of Nintendo Wii Balance Gaming system

Wii whilst on waiting list and rehab

ACTIVE COMPARATOR

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

Interventions

Use of Nintendo Wii Balance Gaming systemOTHER

Use of Nintendo Wii Balance Gaming system

Also known as: Nintendo, Wii, Balance Board, Wii Fit
Wii during vestibular rehab onlyWii whilst on waiting list and rehab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • John A Rutka, MD FRCS(C)

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 28, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

CA(1)