search
Back to results

Home-based Computer Gaming in Vestibular Rehabilitation

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
home-based computer gaming
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vestibular Disorders focused on measuring dizziness, vertigo, unsteadiness, unbalance, falls

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Manitoba, School of Medical Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

home-based computer gaming

Arm Description

computer gaming, balance exercises carried out at home for 20 minutes 5 days/week and monitored by a physical therapist.

Outcomes

Primary Outcome Measures

Centre of Foot Pressure (COP) - Group mean and standard error mean (SEM) of Total Path Length (TPL) in Medial-Lateral and Anterior-Posterior Directions.

Secondary Outcome Measures

Trunk Stability - p-value and effect size of trunk root mean square (RMS) angular velocity in Medial-Lateral and Anterior-Posterior directions.

Full Information

First Posted
September 9, 2013
Last Updated
September 12, 2013
Sponsor
University of Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT01943955
Brief Title
Home-based Computer Gaming in Vestibular Rehabilitation
Official Title
Home-based Computer Gaming in Vestibular Rehabilitation: Effects on Gaze and Balance Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vestibular Disorders, Vestibular Syndromes &/or Disorders (Labyrinthine), Vestibular Neuronitis
Keywords
dizziness, vertigo, unsteadiness, unbalance, falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
home-based computer gaming
Arm Type
Experimental
Arm Description
computer gaming, balance exercises carried out at home for 20 minutes 5 days/week and monitored by a physical therapist.
Intervention Type
Behavioral
Intervention Name(s)
home-based computer gaming
Other Intervention Name(s)
home-based computer gaming for people with PVD
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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
Title
Dizziness - percentiles and p-values for Dizziness Handicap Inventory (DHI)
Time Frame
change from baseline in dizziness at 12 weeks
Title
Gait Stability - percentiles and p-values for Dynamic Gait Index (DGI)
Time Frame
change from baseline in gait stability at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Szturm, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen M Reimer, MSc
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba, School of Medical Rehabilitation
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0T6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Home-based Computer Gaming in Vestibular Rehabilitation

We'll reach out to this number within 24 hrs