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Otolith Dysfunction

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ClinicalTrials.gov Identifier: NCT02652442
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Recent studies suggest that otolith dysfunction is a common finding in individuals with a history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith dysfunction may be a significant health concern for the Veteran population, and determining optimal intervention strategies for otolith dysfunction is important for VA healthcare. The purpose of this project is to compare the effectiveness of standard vestibular rehabilitation compared to a novel treatment approach, centrifugation, in the treatment of individuals with otolith dysfunction.

Condition or disease Intervention/treatment Phase
Dizziness Behavioral: Gaze stability exercises Behavioral: Centrifugation Behavioral: Balance rehabilitation Not Applicable

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 hSCC 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). The concept of using centrifugation for otolith adaptation may be similar to using gaze stability exercises for VOR adaptation. Participants with dizziness/imbalance related to otolith dysfunction will be randomized to receive a staged intervention of either gaze stability exercises (n=14) or centrifugation (n=14) followed by balance rehabilitation. Providing the intervention in stages allows isolation of key components of vestibular rehabilitation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation and Otolith Dysfunction
Actual Study Start Date : January 4, 2016
Estimated Primary Completion Date : May 11, 2018
Estimated Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: vestibular rehabilitation

Gaze stability exercises include adaptation and substitution exercises. Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Substitution exercises specifically attempt to facilitate use of alternative strategies, rather than teaching the specific strategies. Participants will perform brief periods of gaze stability exercises 3 times daily.

In addition, participants will perform balance and gait exercises to improve postural stability and mobility and will be provided a written home exercise program.

Behavioral: Gaze stability exercises
Gaze stability exercises include adaptation and substitution exercises. Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Substitution exercises specifically attempt to facilitate use of alternative strategies, rather than teaching the specific strategies. For example, during active eye-head exercise, a large eye movement to a target is made prior to the head moving to the target, potentially facilitating preprogrammed eye movements.

Behavioral: Balance rehabilitation
All participants will perform balance and gait exercises and will be provided a written home exercise program consisting of exercises designed to improve postural stability and mobility with progressively more challenging tasks.

Experimental: centrifugation

Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 7-8 cm off-axis and the other ear positioned on-axis. Following a 5-minute rest period, the procedure will be repeated with the opposite ear positioned off-axis. Participants will receive 10 sessions in a 4-week period.

In addition, participants will perform balance and gait exercises to improve postural stability and mobility and will be provided a written home exercise program.

Behavioral: Centrifugation
Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 7-8 cm off-axis and the other ear positioned on-axis. Following a 5-minute rest period, the procedure will be repeated with the opposite ear positioned off-axis. Participants will receive 10 sessions in a 4-week period.

Behavioral: Balance rehabilitation
All participants will perform balance and gait exercises and will be provided a written home exercise program consisting of exercises designed to improve postural stability and mobility with progressively more challenging tasks.




Primary Outcome Measures :
  1. change in static subjective visual vertical [ Time Frame: baseline and 4- and 8-weeks ]
    Assesses spatial perception and is influenced by otolith function. Perception of vertical is measured in a darkened room with subject seated upright.

  2. change in symptom intensity [ Time Frame: baseline and 4- and 8-weeks ]
    Self-perceived dizziness and imbalance during gait and sitting will be assessed using visual analogue scales. Subjects place a mark on a 10-cm line at a point corresponding to the intensity of symptoms.

  3. change in sensory organization test [ Time Frame: baseline and 4- and 8-weeks ]
    Assesses use of sensory input by measuring sway under conditions in which visual/somatosensory feedback is altered.

  4. change in Activities-specific balance confidence [ Time Frame: baseline and 4- and 8-weeks ]
    Self-report of confidence to maintain balance in a variety of situations. Subjects indicate confidence (0-100%) with their balance across a continuum of activities.

  5. change in dynamic gait index [ Time Frame: baseline and 4- and 8-weeks ]
    Incorporates gait items that are particularly difficult for people with vestibular disorders -change in speed, head turns, obstacle avoidance, and indicates fall risk.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652442


Locations
United States, Tennessee
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, United States, 37684
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Courtney D Hall, PhD PT Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02652442     History of Changes
Other Study ID Numbers: C2058-P
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
dizziness
postural balance
rehabilitation

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