Vestibular Rehabilitation and Otolith Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary function of the vestibular (inner ear balance) system is to maintain gaze and postural stability. The vestibular system is comprised of two types of sensory organs (semicircular canals and otolith organs) each with unique contributions to balance.
Vestibular Rehabilitation (VR) is the treatment of choice for patients experiencing dizziness, imbalance, and mobility impairments related to vestibular dysfunction. VR typically includes gaze stability exercises, gait and balance training, and general conditioning. Gaze stability exercises were developed based on the concepts of adaptation and substitution with the goal of improving gaze stability by facilitating vestibular compensation of the semicircular canal-mediated vestibulo-ocular reflex (VOR).
Many factors that might influence recovery, such as the involvement of different vestibular sensory organs (semicircular canals versus otolith organs) have not been examined to determine their impact on recovery. Most studies examining the effectiveness of VR have used only tests of VOR function (caloric and rotational tests) that measure horizontal semicircular canal to determine vestibular loss. Thus, little is known about interventions to facilitate vestibular compensation of the otolith organs.
Recent studies have demonstrated adaptation following otolith organ stimulation using centrifugation (or linear acceleration), but there is no data regarding optimum stimulus parameters. The concept of using centrifugation for otolith adaptation may be similar to using gaze stability exercises for VOR adaptation. Healthy control subjects (n = 5 per experiment) will participate in three separate experiments to determine: (1) the optimum off-axis distance of the rotary chair, (2) the optimum duration of off-axis rotation (OAR), and (3) the optimum OAR stimulation/training schedule.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Mountain Home, Tennessee, United States, 37684
- Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years of age
- Documented balance or mobility problems, or healthy control without imbalance
- Otolith dysfunction or healthy control without vestibular dysfunction
Exclusion Criteria:
- Progressive neurological disorders and central vestibular abnormalities
- Benign paroxysmal positional vertigo
- Superior semicircular canal dehiscence
- Middle-ear pathology with conductive hearing loss
- Lower extremity joint replacement
- Cognitive impairment (Mini Mental Status Exam < 24/30)
- Severe depression (geriatric depression scale 10)
- Severe anxiety (geriatric anxiety inventory 11/30)
- Best-corrected visual acuity worse than 20/40 in the better eye
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Centrifugation Parameters
Three experiments were performed to identify optimal centrifugation parameters: (1) distance off-axis (3.5 vs 7 cm); (2) duration (1 min vs 3 mins); (3) schedule (daily vs biweekly).
The comparisons were all within subjects; i.e., each subject was tested systematically for each centrifugation parameter under both conditions.
The change in the outcome measure SVV (from pre- to post-off-axis rotation) for each condition (e.g., 3.5 vs 7 cm) within a parameter was compared.
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To determine optimal distance off-axis, participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute.
Participants received 5 sessions in a 1-week period.
Following a 2-week washout period, participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute.
Participants received 5 sessions in a 1-week period.
To determine optimal duration, after a two week washout period, participants were rotated off-axis at 3.5 cm (determined to be optimal in Exp 1) for 3 minutes.
Participants received 5 sessions in a 1-week period.
To determine optimal schedule, after a two week washout period, participants were rotated off-axis at 3.5 cm (determined to be optimal in Exp 1) for 3 minutes (determined to be optimal in Exp 2).
Participants received biweekly sessions for a total of 5 sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Static Subjective Visual Vertical (SVV)
Time Frame: baseline, immediately after 5 sessions of OAR training (1 week)
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Static subjective visual vertical (SVV) assesses spatial perception and is influenced by otolith function.
Perception of vertical is measured in a darkened room with subject seated upright.
The test assesses an individual's ability to adjust a laser line to be parallel with true vertical in the absence of any other visual cues.
The start position of line for SVV testing is randomized and participants are instructed to use the track ball to position the line in a vertical position.
Five trials are completed, and the software calculates the distance (in degrees) from vertical.
The average of the trials is calculated and used for data analysis.
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baseline, immediately after 5 sessions of OAR training (1 week)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2058-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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