Vestibular Rehabilitation and Dizziness
DZO
1 other identifier
interventional
49
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedResults Posted
Study results publicly available
August 22, 2018
CompletedAugust 22, 2018
August 1, 2018
3.9 years
November 13, 2012
October 17, 2017
August 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6 weeks
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.
6 weeks
Secondary Outcomes (3)
Dynamic Gait Index
6 weeks
Activities-specific Balance Confidence Scale
6 weeks
10 Meter Walk Test
6 weeks
Study Arms (2)
gaze stability
EXPERIMENTALstandard balance rehabilitation plus vestibular-specific exercises
control
PLACEBO COMPARATORstandard balance rehabilitation plus placebo eye exercises
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- at least 50 years of age
- documented balance or mobility problems
- normal vestibular function, including otolith function
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033, United States
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, 37684, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
High dropout rate; small sample size
Results Point of Contact
- Title
- Dr. Courtney Hall
- Organization
- James H Quillen VAMC
Study Officials
- PRINCIPAL INVESTIGATOR
Courtney D Hall, PhD PT
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2012
First Posted
November 20, 2012
Study Start
November 1, 2012
Primary Completion
September 30, 2016
Study Completion
February 28, 2017
Last Updated
August 22, 2018
Results First Posted
August 22, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share