Clinical Trials Directory

Trials / Completed

CompletedNCT02652442

Vestibular Rehabilitation and Otolith Dysfunction

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years – 69 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCentrifugation DistanceTo 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.
BEHAVIORALCentrifugation DurationTo 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.
BEHAVIORALCentrifugation ScheduleTo 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.

Timeline

Start date
2016-01-04
Primary completion
2020-07-06
Completion
2020-07-06
First posted
2016-01-11
Last updated
2021-11-04
Results posted
2021-11-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02652442. Inclusion in this directory is not an endorsement.