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CompletedNCT01943955Updated Sep 17, 2013

Home-based Computer Gaming in Vestibular Rehabilitation

An interventional study of home-based computer gaming in Peripheral Vestibular Disorders, Vestibular Syndromes &/or Disorders (Labyrinthine) and Vestibular Neuronitis, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Peripheral Vestibular Disorders
  • Vestibular Syndromes &/or Disorders (Labyrinthine)
  • Vestibular Neuronitis

Keywords

  • dizziness
  • vertigo
  • unsteadiness
  • unbalance
  • falls
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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.

    Behavioral: home-based computer gaming

Interventions

  • Behavioralhome-based computer gaming

    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.

    Also known as: home-based computer gaming for people with PVD

05

What researchers measure

Primary outcomes

  1. 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

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.

    Time frame: Change from baseline in trunk stability at 12 weeks

Other outcomes

  1. 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

  2. Dizziness - percentiles and p-values for Dizziness Handicap Inventory (DHI)

    Time frame: change from baseline in dizziness at 12 weeks

  3. Gait Stability - percentiles and p-values for Dynamic Gait Index (DGI)

    Time frame: change from baseline in gait stability at 12 weeks

06

Study locations

1 site
  • University of Manitoba, School of Medical Rehabilitation
    Winnipeg, Manitoba R3E0T6, Canada
07

Registry details

Key details

Study ID
NCT01943955
Lead sponsor
University of Manitoba
Responsible party
Sponsor
First posted
Sep 17, 2013
Start date
May 2011
Primary completion
Dec 2012
Completion
Jun 2013
Last update
Sep 17, 2013

Study contacts

Tony Szturm, PhD
principal investigator · University of Manitoba
Karen M Reimer, MSc
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
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