Vestibular DiseasesNCT01305278
The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
A study testing Use of Nintendo Wii Balance Gaming system in people with Vestibular Diseases and Disturbance; Balance, Labyrinth, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Diseases, Disturbance; Balance, Labyrinth
- What is being tested?
- Use of Nintendo Wii Balance Gaming system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral vestibular loss
- Uncompensated
- Present for >6 months
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
None required
- Being tested
- Use of Nintendo Wii Balance Gaming system
- Keywords
- Balance, Rehabilitation, Vestibular
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Nintendo Wii Balance Gaming systemOther
Also called Nintendo, Wii, Balance Board, Wii Fit
Use of Nintendo Wii Balance Gaming system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Use of Nintendo Wii Balance Gaming system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: t=18 weeks
Secondary outcomes (3)
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)
Measured: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
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)
Measured: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
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)
Measured: t=0 (at initial assessment), t=12 weeks, t=18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: We unfortunately experienced recruitment difficulties with this study for the past few years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Pothier, University Health Network, Toronto
- Investigators
- John A Rutka, MD FRCS(C), Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305278
- Sponsor's protocol ID
- UHN-TGH-NO-0004
- Status last verified
- Oct 2016
- First submitted
- 16 Feb 2011
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
- ClinicalTrials.gov ID
- NCT01305278
- Acronym / sponsor ID
- UHN-TGH-NO-0004
- Keywords
- Balance, Rehabilitation, Vestibular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We unfortunately experienced recruitment difficulties with this study for the past few years.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
None required
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No Wii balance gaming undertaken |
| Wii during vestibular rehab only | Active comparator | Other: Use of Nintendo Wii Balance Gaming systemTo start Wii Balance Gaming from the beginning of vestibular rehabilitation. |
| Wii whilst on waiting list and rehab | Active comparator | Other: Use of Nintendo Wii Balance Gaming systemWii Balance Gaming whilst on waiting list for vestibular rehabilitation. To continue with Wii Balance Gaming until end of vestibular rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral vestibular loss
- Uncompensated
- Present for >6 months
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Nintendo Wii Balance Gaming systemAlso: Nintendo, Wii, Balance Board, Wii FitUse of Nintendo Wii Balance Gaming system | Other | Wii during vestibular rehab only, Wii whilst on waiting list and rehab |
Primary outcome
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)
3 secondary outcomes
Modified Clinical Test of Sensory Interaction on Balance
Time frame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Activity Specific Balance Confidence Scale
Time frame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
Dynamic Gait Index score
Time frame: t=0 (at initial assessment), t=12 weeks, t=18 weeks
Results and safety
The study was stopped early (reason given: We unfortunately experienced recruitment difficulties with this study for the past few years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
Related trials for Vestibular Diseases
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Rutka, MD FRCS(C) principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Nintendo Wii Balance Gaming system in people with Vestibular Diseases and Disturbance; Balance, Labyrinth, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We unfortunately experienced recruitment difficulties with this study for the past few years.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Index (time frame: t=0 (at initial assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.