Game Based Vestibular Exercise for Home Rehabilitation

NCT02134444 | Unknown

• 1 other identifier: not yet conducted
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 2.Compare trajectory of change in electronic gaze performance measures obtained during each therapy session of each participant assigned to the home Telerehabilitation.

Conditions

Peripheral Vestibular Disorders; Dizziness

Keywords

Dizziness; Vertigo; Vestibular Diseases; Vestibular Neuritis; Labyrinth Diseases; Ear Diseases; Vestibular rehabilitation; Telerehabilitation; Gaze control; Balance

Outcome Measures

Primary Outcomes (4)

• Standing Balance

  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.

  Pre and post intervention of 12 weeks

• Dizziness Handicap Inventory (DHI)

  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.

  Pre and post intervention of 12 weeks

• Computerized Visual Tracking Performance

  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

  Pre and post intervention of 12 weeks

• Spatial - temporal gait variables during treadmill walking with and without visual tracking task.

  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

  Pre and post intervention of 12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group will receive the assigned intervention which is a game-based rehabilitation program delivered at home.

Behavioral: Experimental group

Control group

ACTIVE COMPARATOR

Control group will receive a vestibular rehabilitation program which will include the Herdman gaze stabilization exercises and balance training program.

Behavioral: Control group

Interventions

Experimental group BEHAVIORAL

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.

Experimental Group

Control group BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-60
• English speaking
• 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;
• Have a home computer running Windows or Mac OS. 5 Adequate hearing and vision acuity

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

RECRUITING

Related Publications (6)

• Szturm T, Betker AL, Moussavi Z, Desai A, Goodman V. Effects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trial. Phys Ther. 2011 Oct;91(10):1449-62. doi: 10.2522/ptj.20090205. Epub 2011 Jul 28.

  PMID: 21799138 BACKGROUND

• Desai A, Goodman V, Kapadia N, Shay BL, Szturm T. Relationship between dynamic balance measures and functional performance in community-dwelling elderly people. Phys Ther. 2010 May;90(5):748-60. doi: 10.2522/ptj.20090100. Epub 2010 Mar 11.

  PMID: 20223944 BACKGROUND

• Szturm T, Maharjan P, Marotta JJ, Shay B, Shrestha S, Sakhalkar V. The interacting effect of cognitive and motor task demands on performance of gait, balance and cognition in young adults. Gait Posture. 2013 Sep;38(4):596-602. doi: 10.1016/j.gaitpost.2013.02.004. Epub 2013 Mar 9.

  PMID: 23477841 BACKGROUND

• Szturm T, Wu c. etal. (2013). Technology-assisted & motivational program for a blended approach to manage balance gaze mobility and cognitive decline with age. OA Evidence-Based Med. Apr;1):1.

  BACKGROUND

• Lockery D, Peters JF, Ramanna S, Shay BL, Szturm T. Store-and-feedforward adaptive gaming system for hand-finger motion tracking in telerehabilitation. IEEE Trans Inf Technol Biomed. 2011 May;15(3):467-73. doi: 10.1109/TITB.2011.2125976.

  PMID: 21536526 BACKGROUND

• Szturm T, Hochman J, Wu C, Lisa L, Reimer K, Wonneck B, Giacobbo A. Games and Telerehabilitation for Balance Impairments and Gaze Dysfunction: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2015 Oct 21;4(4):e118. doi: 10.2196/resprot.4743.

  PMID: 26490109 DERIVED

MeSH Terms

Conditions

Dizziness; Vertigo; Vestibular Diseases; Vestibular Neuronitis; Labyrinth Diseases; Ear Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Diseases; Nervous System Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Szturm, PT, PhD

CONTACT

204-787-4794; tony.szturm@med.umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 8, 2016

Record last verified: 2014-04

Locations

CA (1)