Recruiting

Vestibular Exercise

Sponsor:

University of Manitoba

Code:

NCT02134444

Conditions

Peripheral Vestibular Disorders

Dizziness

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Experimental group

Control group

Study Details

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.

Conditions

Peripheral Vestibular Disorders

Dizziness

Study ID

NCT02134444

Start date

May, 2014

Status verified date

Apr, 2014

Completion date

May, 2016

Anticipated

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

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 .

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Group

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

active comparator: Control group

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

Interventions

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.

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 measure

  • Standing Balance [ Time Frame: Pre and post intervention of 12 weeks ]
  • Dizziness Handicap Inventory (DHI) [ Time Frame: Pre and post intervention of 12 weeks ]
  • Computerized Visual Tracking Performance [ Time Frame: Pre and post intervention of 12 weeks ]
  • Spatial - temporal gait variables during treadmill walking with and without visual tracking task. [ Time Frame: Pre and post intervention of 12 weeks ]

Central Contacts and Locations

Central contacts

Tony Szturm, PT, PhD

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

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0T6

Contacts

Tony Szturm, PT, PhD

2047874704tony.szturm@med.umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Jan 8, 2016

Last verified

Apr, 2014

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2016-01-08.