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Vestibular Rehabilitation and Dizziness in Geriatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00275392
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : October 17, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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Brief Summary:
The purpose of this study is to develop effective exercise intervention to reduce dizziness and fall risk in older adults with non-specific dizziness. We hypothesize that the use of vestibular exercises can reduce dizziness and improve gaze and postural stability in older persons.

Condition or disease Intervention/treatment Phase
Dizziness Behavioral: Vestibular rehabilitation Behavioral: Placebo Not Applicable

Detailed Description:

Community dwelling older individuals who present to a specialty dizziness clinic (Atlanta VAMC or Emory University) with a primary complaint of dizziness will be recruited to participate in this study. Before beginning the study, the presence of normal vestibular function will be measured directly using standard vestibular function tests. Individuals will be randomly assigned to the vestibular exercise group (VR) or to the control group (CON). Data will be collected prior to the initiation of physical therapy and at the completion of the 6-week intervention period.

The VR group will perform vestibular exercises plus balance and gait exercises. The CON group will perform saccadic eye movements without targets against a blank wall, as well as balance and gait exercises. The balance and gait exercises for each group will be based on identified impairments and functional limitations, as is the standard of care in physical therapy. All subjects within a group will follow the same exercise progression for the vestibular or eye movement exercises. Subjects will be seen in the clinic on a weekly basis to review and modify the exercises according to a standard protocol and to reinforce compliance.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation and Dizziness in Geriatric Patients
Study Start Date : April 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vestibular Rehabilitation
vestibular exercises plus standard balance and gait exercises
 Behavioral: Vestibular rehabilitation
vestibular adaptation and substitution exercises
Placebo Comparator: Placebo
placebo exercises plus standard balance and gait exercises
 Behavioral: Placebo
placebo vestibular exercises


Outcome Measures
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Primary Outcome Measures :
  1. Dynamic Gait Index [ Time Frame: 6 weeks ]
    Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 20 indicates risk for falling.


Secondary Outcome Measures :
  1. Dynamic Visual Acuity [ Time Frame: 6 weeks ]
    Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must be at least 60 years of age, seeking medical care due to dizziness and have normal vestibular function based on results of the clinical examination, rotary chair and/or caloric tests.

Exclusion Criteria:

Abnormal vestibular function based on results of clinical examination, rotary chair and/or caloric tests.

Contacts and Locations
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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): NCT00275392


Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Courtney D. Hall, PhD PT Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00275392    
Other Study ID Numbers: C4168-P
First Posted: January 11, 2006    Key Record Dates
Results First Posted: October 17, 2014
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Dizziness
Geriatrics
Rehabilitation
Vestibular rehabilitation
Additional relevant MeSH terms:
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Vertigo
Dizziness
Sensation Disorders
Neurologic Manifestations
Vestibular Diseases
 Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases