Peripheral Vestibular DisordersNCT01943955
Home-based Computer Gaming in Vestibular Rehabilitation
A study testing home-based computer gaming in people with Peripheral Vestibular Disorders and Vestibular Syndromes &/or Disorders (Labyrinthine), run by University of Manitoba at 1 site in Canada.
Trial summary
It is hypothesized that a home-based computer gaming rehabilitation program will improve gaze control and balance impairments in those with peripheral vestibular disorders (PVD). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Peripheral Vestibular Disorders, Vestibular Syndromes &/or Disorders (Labyrinthine), Vestibular Neuronitis
- What is being tested?
- home-based computer gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Jun 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of peripheral vestibular disorder (confirmed on electronystagmography, bithermal caloric testing, neuro-ophthalmic, neuro-orthoptic examination)
- Access to a home computer
Who cannot join
- Central Nervous System disorders
- Vestibular migraine
- Benign Paroxysmal Positional Vertigo (BPPV)
- Recent fractures of the spine or lower extremities
- Inability to tolerate standing for 20 minutes
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba, School of Medical Rehabilitation
Winnipeg, Manitoba, R3E0T6
About this study
Official title: Home-based Computer Gaming in Vestibular Rehabilitation: Effects on Gaze and Balance Impairment
It is hypothesized that a home-based computer gaming rehabilitation program will improve gaze control and balance impairments in those with peripheral vestibular disorders (PVD). Ten people with peripheral vestibular disorders were started on a treatment program that consisted of playing computer games and while performing various balance exercises. On a weekly basis, each participant was contacted by email or telephone and asked to submit their computer gaming data to a trained vestibular physical therapist. Following review of this data, the physical therapist would contact the participant and progress their computer gaming program appropriately. At the completion of twelve weeks of home treatment, the participants returned for re-assessment and it was determined that the computer gaming program was an effective treatment for those with PVD. It was also determined that a monitored telerehabilitation program was an efficient and effective delivery method for this treatment.
Read the detailed description
A pre to post intervention case series study was carried out on ten participants diagnosed with peripheral vestibular disorders (PVD). Inclusion criteria consisted of: a) 20 to 70 year old, b) confirmed diagnosis of PVD on neuro-opthalmic, neuro-orthoptic, electronystagmography and caloric testing; and use of a home computer. Exclusion criteria consisted of those with migraine, central nervous system disorders (for example cerebral vascular accident or Multiple Sclerosis), recent fractures of the spine or lower extremities, inability to stand for 20 minutes continuously, or presence of dementia. It was hypothesized that a home-based computer gaming treatment delivered in a monitored telerehabilitation platform would be an effective treatment for those with PVD in that increased gaze stability and improved balance would be observed post-treatment. It was also hypothesized that decreased dizziness would be reported post-treatment. After initial assessment (pre-treatment), three in-clinic sessions were given to each participant to develop their specific home treatment computer program and ensure ability to use the program effectively. They were then started on their home program and monitored by a trained vestibular physical therapist for a 12-week telerehabilitation program. After the completion of the 12-weeks, the participants returned for a post-treatment assessment.
- Conditions
- Peripheral Vestibular Disorders, Vestibular Syndromes &/or Disorders (Labyrinthine), Vestibular Neuronitis
- Being tested
- home-based computer gaming
- Keywords
- dizziness, vertigo, unsteadiness, unbalance, falls
- Medical subject headings
- Vestibular Neuronitis, Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based computer gamingBehavioural
Also called home-based computer gaming for people with PVD
A computer mouse mounted to a headband and placed on the participant's head is used to interact with the game cursor. In order to interact with/play the game the participant must visually focus on the moving target and perform unpredictable head movements. Balance exercises are incorporated progressively and simultaneously during computer gaming.
| Study group | Role | What they receive |
|---|---|---|
| home-based computer gaming | Experimental | computer gaming, balance exercises carried out at home for 20 minutes 5 days/week and monitored by a physical therapist. Receives: Behavioral: home-based computer gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centre of Foot Pressure (COP) - Group mean and standard error mean (SEM) of Total Path Length (TPL) in Medial-Lateral and Anterior-Posterior Directions.
Measured: Change from baseline in COP at 12 weeks
Secondary outcomes (1)
Trunk Stability - p-value and effect size of trunk root mean square (RMS) angular velocity in Medial-Lateral and Anterior-Posterior directions.
Measured: Change from baseline in trunk stability at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vestibular DisordersStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony Szturm, PhD, Principal investigator, University of ManitobaKaren M Reimer, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943955
- Sponsor's protocol ID
- HS14167
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Computer Gaming in Vestibular Rehabilitation: Effects on Gaze and Balance Impairment
- ClinicalTrials.gov ID
- NCT01943955
- Acronym / sponsor ID
- HS14167
- Conditions
- Peripheral Vestibular Disorders, Vestibular Syndromes &/or Disorders (Labyrinthine), Vestibular Neuronitis
- Keywords
- dizziness, vertigo, unsteadiness, unbalance, falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Sep 2013 (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.
It is hypothesized that a home-based computer gaming rehabilitation program will improve gaze control and balance impairments in those with peripheral vestibular disorders (PVD). Ten people with peripheral vestibular disorders were started on a treatment program that consisted of playing computer games and while performing various balance exercises. On a weekly basis, each participant was contacted by email or telephone and asked to submit their computer gaming data to a trained vestibular physical therapist. Following review of this data, the physical therapist would contact the participant and progress their computer gaming program appropriately. At the completion of twelve weeks of home treatment, the participants returned for re-assessment and it was determined that the computer gaming program was an effective treatment for those with PVD. It was also determined that a monitored telerehabilitation program was an efficient and effective delivery method for this treatment.
Detailed description
A pre to post intervention case series study was carried out on ten participants diagnosed with peripheral vestibular disorders (PVD). Inclusion criteria consisted of: a) 20 to 70 year old, b) confirmed diagnosis of PVD on neuro-opthalmic, neuro-orthoptic, electronystagmography and caloric testing; and use of a home computer. Exclusion criteria consisted of those with migraine, central nervous system disorders (for example cerebral vascular accident or Multiple Sclerosis), recent fractures of the spine or lower extremities, inability to stand for 20 minutes continuously, or presence of dementia. It was hypothesized that a home-based computer gaming treatment delivered in a monitored telerehabilitation platform would be an effective treatment for those with PVD in that increased gaze stability and improved balance would be observed post-treatment. It was also hypothesized that decreased dizziness would be reported post-treatment. After initial assessment (pre-treatment), three in-clinic sessions were given to each participant to develop their specific home treatment computer program and ensure ability to use the program effectively. They were then started on their home program and monitored by a trained vestibular physical therapist for a 12-week telerehabilitation program. After the completion of the 12-weeks, the participants returned for a post-treatment assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| home-based computer gaming | Experimental | Behavioral: home-based computer gamingcomputer gaming, balance exercises carried out at home for 20 minutes 5 days/week and monitored by a physical therapist. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of peripheral vestibular disorder (confirmed on electronystagmography, bithermal caloric testing, neuro-ophthalmic, neuro-orthoptic examination)
- Access to a home computer
Key exclusion criteria (5 listed)
- Central Nervous System disorders
- Vestibular migraine
- Benign Paroxysmal Positional Vertigo (BPPV)
- Recent fractures of the spine or lower extremities
- Inability to tolerate standing for 20 minutes
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 |
|---|---|---|
| home-based computer gamingAlso: home-based computer gaming for people with PVDA computer mouse mounted to a headband and placed on the participant's head is used to interact with the game cursor. In order to interact with/play the game the participant must visually focus on the moving target and perform unpredictable head movements. Balance exercises are incorporated progressively and simultaneously during computer gaming. | Behavioural | home-based computer gaming |
Primary outcome
Centre of Foot Pressure (COP) - Group mean and standard error mean (SEM) of Total Path Length (TPL) in Medial-Lateral and Anterior-Posterior Directions.
Time frame: Change from baseline in COP at 12 weeks
1 secondary outcome
Trunk Stability - p-value and effect size of trunk root mean square (RMS) angular velocity in Medial-Lateral and Anterior-Posterior directions.
Time frame: Change from baseline in trunk stability at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Tony Szturm, PhD principal investigator
University of Manitoba
Karen M Reimer, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based computer gaming in people with Peripheral Vestibular Disorders and Vestibular Syndromes &/or Disorders (Labyrinthine), run by University of Manitoba 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 17 Sep 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Centre of Foot Pressure (COP) - Group mean and standard error mean (SEM) of Total Path Length (TPL) in Medial-Lateral and Anterior-Posterior Directions. (time frame: Change from baseline in COP at 12 weeks). 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 17 Sep 2013.