NCT01943955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1.6 years

First QC Date

September 9, 2013

Last Update Submit

September 12, 2013

Conditions

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

Keywords

dizzinessvertigounsteadinessunbalancefalls

Outcome Measures

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.

    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.

    Change from baseline in trunk stability at 12 weeks

Other Outcomes (3)

  • 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

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

    change from baseline in dizziness at 12 weeks

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

    change from baseline in gait stability at 12 weeks

Study Arms (1)

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.

Behavioral: home-based computer gaming

Interventions

home-based computer gamingBEHAVIORAL

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
home-based computer gaming

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of peripheral vestibular disorder (confirmed on electronystagmography, bithermal caloric testing, neuro-ophthalmic, neuro-orthoptic examination)
  • Access to a home computer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba, School of Medical Rehabilitation

Winnipeg, Manitoba, R3E0T6, Canada

Location

MeSH Terms

Conditions

Vestibular NeuronitisDizzinessVertigo

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve DiseasesNervous System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth Diseases

Study Officials

  • Tony Szturm, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

  • Karen M Reimer, MSc

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 17, 2013

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

CA(1)