Home-based Computer Gaming in Vestibular Rehabilitation

Vestibular Neuronitis Clinical Trial

Official title:

Home-based Computer Gaming in Vestibular Rehabilitation: Effects on Gaze and Balance Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943955
• Other study ID #: HS14167
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: September 12, 2013
• Start date: May 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• home-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.

Locations

Country	Name	City	State
Canada	University of Manitoba, School of Medical Rehabilitation	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.		change from baseline in gaze stability at 12 weeks	No
Other	Dizziness - percentiles and p-values for Dizziness Handicap Inventory (DHI)		change from baseline in dizziness at 12 weeks	No
Other	Gait Stability - percentiles and p-values for Dynamic Gait Index (DGI)		change from baseline in gait stability at 12 weeks	No
Primary	Centre of Foot Pressure (COP) - Group mean and standard error mean (SEM) of Total Path Length (TPL) in Medial-Lateral and Anterior-Posterior Directions.		Change from baseline in COP at 12 weeks	No
Secondary	Trunk Stability - p-value and effect size of trunk root mean square (RMS) angular velocity in Medial-Lateral and Anterior-Posterior directions.		Change from baseline in trunk stability at 12 weeks	No