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Vestibular Rehabilitation and Dizziness (DZO)

Primary Purpose

Dizziness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard balance rehabilitation
gaze stability
Control
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness focused on measuring rehabilitation, aged, aged, 80 and over, vestibular diseases

Eligibility Criteria

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

Inclusion Criteria:

  • at least 50 years of age
  • documented balance or mobility problems
  • normal vestibular function, including otolith function

Exclusion Criteria:

  • cognitive impairment
  • progressive medical issues that would impact mobility (e.g., Parkinson's disease, cerebellar atrophy)
  • dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo (BPPV)

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gaze stability

control

Arm Description

standard balance rehabilitation plus vestibular-specific exercises

standard balance rehabilitation plus placebo eye exercises

Outcomes

Primary Outcome Measures

Visual Analog Scale - Head Movement
This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.
Visual Analog Scale - Disequilibrium
This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.

Secondary Outcome Measures

Dynamic Gait Index
The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of < 20 indicate high risk for falling.
Activities-specific Balance Confidence Scale
As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.
10 Meter Walk Test
This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.

Full Information

First Posted
November 13, 2012
Last Updated
August 20, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01729039
Brief Title
Vestibular Rehabilitation and Dizziness
Acronym
DZO
Official Title
Vestibular Rehabilitation and Dizziness in Geriatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether vestibular exercises provide added benefit to balance rehabilitation in older adults with dizziness and normal vestibular function.
Detailed Description
Dizziness is among the most prevalent complaints for which people seek medical help and the incidence increases with advancing age. Dizziness represents a diagnostic and treatment challenge because it is a subjective sensation, refers to a variety of symptoms (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential contributory factors. Dizziness is often related to vestibular disease which is treated effectively with vestibular exercises. Successful management of dizziness is critical because dizziness is a major risk factor for falls in older adults. There are parallels between the effects of age-related versus disease-related loss of vestibular function - in complaints of dizziness and increased risk for falls. The investigators' question, then, is whether the same exercises that are beneficial for patients with vestibular pathology are beneficial for older patients with dizziness but normal vestibular function. Older adults with dizziness who have been referred to Audiology for vestibular evaluation will be randomized to receive either standard balance rehabilitation plus placebo eye exercises (CON) or standard balance rehabilitation plus vestibular-specific exercises (GS). Primary outcomes include symptoms, balance-related confidence, dynamic visual acuity, postural stability as measured by sensory organization test, fall risk as measured by dynamic gait index, and gait speed. Assessment will occur at baseline, discharge from physical therapy (PT), 1 and 6 months post-PT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness
Keywords
rehabilitation, aged, aged, 80 and over, vestibular diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gaze stability
Arm Type
Experimental
Arm Description
standard balance rehabilitation plus vestibular-specific exercises
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
standard balance rehabilitation plus placebo eye exercises
Intervention Type
Behavioral
Intervention Name(s)
standard balance rehabilitation
Intervention Description
All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.
Intervention Type
Behavioral
Intervention Name(s)
gaze stability
Intervention Description
Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target, potentially facilitating use of preprogrammed eye movements.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
Primary Outcome Measure Information:
Title
Visual Analog Scale - Head Movement
Description
This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.
Time Frame
6 weeks
Title
Visual Analog Scale - Disequilibrium
Description
This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Dynamic Gait Index
Description
The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of < 20 indicate high risk for falling.
Time Frame
6 weeks
Title
Activities-specific Balance Confidence Scale
Description
As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.
Time Frame
6 weeks
Title
10 Meter Walk Test
Description
This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 50 years of age documented balance or mobility problems normal vestibular function, including otolith function Exclusion Criteria: cognitive impairment progressive medical issues that would impact mobility (e.g., Parkinson's disease, cerebellar atrophy) dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo (BPPV)
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, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
City
Mountain Home
State/Province
Tennessee
ZIP/Postal Code
37684
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vestibular Rehabilitation and Dizziness

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