- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943955
Home-based Computer Gaming in Vestibular Rehabilitation
September 12, 2013 updated by: University of Manitoba
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E0T6
- University of Manitoba, School of Medical Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of peripheral vestibular disorder (confirmed on electronystagmography, bithermal caloric testing, neuro-ophthalmic, neuro-orthoptic examination)
- Access to a home computer
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: home-based computer gaming
computer gaming, balance exercises carried out at home for 20 minutes 5 days/week and monitored by a physical therapist.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Change from baseline in COP at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Change from baseline in trunk stability at 12 weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gaze Stability - group mean and standard error mean (SEM) of open loop (OL) and closed loop (CL) visual tracking tasks during standing on fixed and sponge surfaces and during treadmill walking at 0.7 mph.
Time Frame: change from baseline in gaze stability at 12 weeks
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change from baseline in gaze stability at 12 weeks
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Dizziness - percentiles and p-values for Dizziness Handicap Inventory (DHI)
Time Frame: change from baseline in dizziness at 12 weeks
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change from baseline in dizziness at 12 weeks
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Gait Stability - percentiles and p-values for Dynamic Gait Index (DGI)
Time Frame: change from baseline in gait stability at 12 weeks
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change from baseline in gait stability at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen M Reimer, MSc, University of Manitoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
September 9, 2013
First Submitted That Met QC Criteria
September 12, 2013
First Posted (ESTIMATE)
September 17, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 17, 2013
Last Update Submitted That Met QC Criteria
September 12, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS14167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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