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Vestibular Rehabilitation and Dizziness in Geriatric Patients

Primary Purpose

Dizziness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular rehabilitation
Placebo
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness focused on measuring Dizziness, Geriatrics, Rehabilitation, Vestibular rehabilitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vestibular Rehabilitation

Placebo

Arm Description

vestibular exercises plus standard balance and gait exercises

placebo exercises plus standard balance and gait exercises

Outcomes

Primary Outcome Measures

Dynamic Gait Index
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

Dynamic Visual Acuity
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.

Full Information

First Posted
January 10, 2006
Last Updated
December 5, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00275392
Brief Title
Vestibular Rehabilitation and Dizziness in Geriatric Patients
Official Title
Vestibular Rehabilitation and Dizziness in Geriatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness
Keywords
Dizziness, Geriatrics, Rehabilitation, Vestibular rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Rehabilitation
Arm Type
Experimental
Arm Description
vestibular exercises plus standard balance and gait exercises
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo exercises plus standard balance and gait exercises
Intervention Type
Behavioral
Intervention Name(s)
Vestibular rehabilitation
Intervention Description
vestibular adaptation and substitution exercises
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
placebo vestibular exercises
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Dynamic Visual Acuity
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney D. Hall, PhD PT
Organizational Affiliation
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20588090
Citation
Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
Results Reference
result

Learn more about this trial

Vestibular Rehabilitation and Dizziness in Geriatric Patients

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