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Vestibular Rehabilitation and Otolith Dysfunction

Primary Purpose

Dizziness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Centrifugation Distance
Centrifugation Duration
Centrifugation Schedule
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dizziness focused on measuring dizziness, postural balance, rehabilitation

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Centrifugation Parameters

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Static Subjective Visual Vertical (SVV)
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2016
Last Updated
October 5, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02652442
Brief Title
Vestibular Rehabilitation and Otolith Dysfunction
Official Title
Vestibular Rehabilitation and Otolith Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
July 6, 2020 (Actual)
Study Completion Date
July 6, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 identify optimum stimulus parameters of a novel treatment, off-axis rotation (centrifugation) for otolith dysfunction, in healthy participants.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness
Keywords
dizziness, postural balance, rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
To determine optimal stimulus parameters for off-axis rotation (OAR), participants progressed through the study starting with off-axis distance (3.5 vs 7.0 cm), off-axis duration (1 vs 3 minutes) and finally training schedule (daily vs biweekly). SVV was measured immediately before and after training. To determine optimal distance, OAR was first performed at 3.5 cm and then 7.0 cm off-axis for 1 minute and the change in SVV compared. Participants trained daily for 5 consecutive days at 3.5 cm followed by a washout period of two weeks, then trained at 7.0 cm. To determine optimal duration, participants were rotated at 3.5 cm off-axis (determined to be optimal) for 3 minutes and the change in SVV was compared to 3.5 cm off-axis for 1 minute. To determine optimal training schedule, participants were rotated at 3.5 cm off-axis for 3 minutes (determined to be optimal) on a biweekly schedule for a total of 5 sessions and change in SVV was compared to the daily training schedule.
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Centrifugation Parameters
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Centrifugation Distance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Centrifugation Duration
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Centrifugation Schedule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Static Subjective Visual Vertical (SVV)
Description
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.
Time Frame
baseline, immediately after 5 sessions of OAR training (1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
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 Otolith Dysfunction

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