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Vestibular Rehabilitation and Dizziness in Geriatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00275392
First received: January 10, 2006
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention
Dizziness
Behavioral: Vestibular rehabilitation
Behavioral: Placebo Vestibular rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation and Dizziness in Geriatric Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Dynamic Gait Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 19 indicates risk for falling.


Secondary Outcome Measures:
  • Dynamic Visual Acuity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: April 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
vestibular exercises plus standard balance and gait exercises
Behavioral: Vestibular rehabilitation
vestibular adaptation and substitution exercises
Placebo Comparator: Arm 2
placebo exercises plus standard balance and gait exercises
Behavioral: Placebo Vestibular rehabilitation
placebo vestibular exercises

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275392

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

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00275392     History of Changes
Other Study ID Numbers: C4168-P
Study First Received: January 10, 2006
Results First Received: September 17, 2014
Last Updated: October 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Dizziness
Geriatrics
Rehabilitation
Vestibular rehabilitation

Additional relevant MeSH terms:
Dizziness
Vertigo
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vestibular Diseases

ClinicalTrials.gov processed this record on November 25, 2014