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Game Based Vestibular Exercise for Home Rehabilitation

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ClinicalTrials.gov Identifier: NCT02134444
Recruitment Status : Unknown
Verified April 2014 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:

Study Description and Purpose:

The vestibular sense organs of the inner ear consist of the semi-circular canals and otolith end organs. These organs contain specialized gravito-inertial sensors that sense angular and linear head acceleration. The input from these sensors is required to stabilize gaze position during head motion, and provide an absolute frame of reference with respect to gravity, thus providing a vertical spatial reference for body orientation and balance. Disease or damage of the vestibular sense organs causes a range of distressing symptoms and functional problems for people that could include loss of balance, gaze instability, disorientation and dizziness. A novel computer based rehabilitation system with therapeutic gaming application has been developed. This method allows different gaze and head movement exercises to be coupled to a wide range of inexpensive, commercial computer games. It can be used in standing and thus graded balance demands using a sponge pad can be incorporated into the program.

Study Objective:

  1. Test the therapeutic effectiveness of the TRP delivered in the home compared to usual care delivered in an out-patient physical therapy clinic on measures of balance (standing and walking) , gaze control, dizziness, and health related quality of life in individuals with peripheral vestibular disorders.
  2. Compare trajectory of change in electronic gaze performance measures obtained during each therapy session of each participant assigned to the home Telerehabilitation.

Hypothesis:

Investigators believe the Telerehabilitation platform to be a cost-effective delivery of rehabilitation. Additionally motivation to perform tedious home programs can be improved with engaging, fun and interactive computer gaming as part of the rehabilitation process. It is hypothesized the home game-based Telerehabilitation program will result in greater improvements in dynamic balance control, gaze control, and dizziness, in individuals with peripheral vestibular disorders as compared to a typical out-patient physical therapy regimen.


Condition or disease Intervention/treatment Phase
Peripheral Vestibular Disorders Dizziness Behavioral: Experimental group Behavioral: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Clinical and Game-based Rehabilitation for Balance Impairments and Gaze Dysfunction in Clients With Vestibular Disorders
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
Experimental group will receive the assigned intervention which is a game-based rehabilitation program delivered at home.
Behavioral: Experimental group
Experimental group will receive a game-based exercise program delivered at home. This includes provision of a head-mounted motion mouse. This provides a treatment tool applied to gaze control, and allows incorporation of balance exercises. It also allows many different therapeutic exercises to be coupled to a wide range of inexpensive commercial computer games. Participants will attend 3 clinical sessions during which time the home therapy programs will be established and training in the use of the motion mouse and games will be provided. The treating physiotherapist will attend the participant's home to ensure proper set-up and operation of the computer applications. Participants will be asked to perform their respective home programs four times per week for 20 minutes per session.

Active Comparator: Control group
Control group will receive a vestibular rehabilitation program which will include the Herdman gaze stabilization exercises and balance training program.
Behavioral: Control group
Control group will receive a vestibular exercise program which will include the Herdman gaze stabilization exercises and balance training program. This program is presently a standard of vestibular care. Participants will attend an out-patient physical therapy clinic once a week for 12 weeks. The program also includes a 20 minute home exercise program prescribed 4 times per week.




Primary Outcome Measures :
  1. Standing Balance [ Time Frame: Pre and post intervention of 12 weeks ]

    This will be measured by performing a) Clinical Test of Sensory Integration of Balance and b) Five - Time Sit-to-Stand Test.

    Centre of Foot Pressure (COP) is recorded during test conditions and root mean square (RMS) and total Path Length ) in Medial-Lateral and Anterior-Posterior Directions is quantified.


  2. Dizziness Handicap Inventory (DHI) [ Time Frame: Pre and post intervention of 12 weeks ]
    It is a self-rating questionnaire based on 25 questions used to quantify a client's perception of his or her dizziness and its impact on their life.

  3. Computerized Visual Tracking Performance [ Time Frame: Pre and post intervention of 12 weeks ]
    A computer application has been developed which involves tracking a bright visual target moving horizontally left and right on a computer display in a sinusoidal fashion for several cycles, and at predetermined speeds. This procedure requires vestibular function and smooth pursuit to coordinate eye and head motions during the active head tracking task. The computer application records (80 Hz) coordinates of both reference and head cursors. Coefficient of determination (COD) will be computed based on total and average residual difference between trajectories of the reference and head cursor motions. A value approaching one equates to excellent gaze performance. This test will be performed in sitting, standing and while walking on a treadmill at 0.9 m/s

  4. Spatial - temporal gait variables during treadmill walking with and without visual tracking task. [ Time Frame: Pre and post intervention of 12 weeks ]

    It will be measured by asking the participants to walk on a treadmill for 1 minute which is instrumented with a pressure mat at a speed of 0.9 m/s. Average and coefficient of variation will be obtained for the following parameters: swing time, step time, step length and step width.

    Participants will repeat the:

    1. Baseline walk not engaged in any visual tracking or head movement task
    2. While performing the CDVA visual tracking task described above for 45 seconds



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age between 20-60
  2. English speaking
  3. Diagnosed with unilateral or bilateral peripheral vestibular hypo function based on a detailed neuro-otological and neuro-orthoptic analysis to include binocular electro-oculography with caloric testing;
  4. Have a home computer running Windows or Mac OS. 5 Adequate hearing and vision acuity

Exclusion Criteria:

  1. Those with CNS disorders for example CVA, Multiple Sclerosis, epilepsy, migraines.
  2. Recent fractures of the lower extremities or vertebra, advanced hip/knee OA ,
  3. Cardiac disease .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134444


Contacts
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Contact: Tony Szturm, PT, PhD 204-787-4794 tony.szturm@med.umanitoba.ca

Locations
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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0T6
Contact: Tony Szturm, PT, PhD    2047874704    tony.szturm@med.umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Tony Szturm, PT, PhD University of Manitoba
Principal Investigator: Jordan Hochman, MD University of Manitoba
Principal Investigator: Lisa Lix, PhD University of Manitoba
Principal Investigator: Christine Wu University of Manitoba
Principal Investigator: Karen Reimer, PT, M.Sc. Private Practice Clinician
Principal Investigator: Andrea Giacobbo, PT Private Practice Clinician
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02134444    
Other Study ID Numbers: not yet conducted
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: April 2014
Keywords provided by University of Manitoba:
Dizziness
Vertigo
Vestibular Diseases
Vestibular Neuritis
Labyrinth Diseases
Ear Diseases
Vestibular rehabilitation
Telerehabilitation
Gaze control
Balance
Additional relevant MeSH terms:
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Vertigo
Vestibular Diseases
Ear Diseases
Dizziness
Sensation Disorders
Neurologic Manifestations
Labyrinth Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases