Vestibular Rehabilitation and Otolith Dysfunction

NCT02652442 | Completed Results

• 1 other identifier: C2058-P
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness

Keywords

dizziness; postural balance; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, immediately after 5 sessions of OAR training (1 week)

Study Arms (1)

Centrifugation Parameters

EXPERIMENTAL

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.

Behavioral: Centrifugation Distance; Behavioral: Centrifugation Duration; Behavioral: Centrifugation Schedule

Interventions

Centrifugation Distance BEHAVIORAL

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.

Centrifugation Parameters

Centrifugation Duration BEHAVIORAL

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.

Centrifugation Parameters

Centrifugation Schedule BEHAVIORAL

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.

Centrifugation Parameters

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Documented balance or mobility problems, or healthy control without imbalance
• Otolith dysfunction or healthy control without vestibular dysfunction

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Mountain Home, Tennessee, 37684, United States

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Health Science Specialist
• Organization: James H Quillen VAMC

courtney.hall@va.gov

(423) 926-1171

Study Officials

• Courtney D Hall, PhD PT

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 11, 2016
• Study Start: January 4, 2016
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)