Dose of Vestibular Rehabilitation for Vestibular Hypofunction

NCT04851184 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-17

Study results available
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Summary

The purposes of this research are to 1) utilize virtual reality (VR) to evaluate the exercise dose required to improve symptoms in those with vestibular (dizziness) disorders, 2) compare VR vestibular exercises to standard exercises, and 3) compare exercise performance outcomes to healthy controls without vestibular disorders. Even though more than 35% of those over 40, and \~50% of those who have had concussion have such symptoms, the dose of specific exercises targeted to improve symptoms is not well defined. In this study, the investigators will use a wireless VR device to measure key parameters and response to exercise. Another advantage of the VR device is the ability to control what the individual can see while performing the exercise. In normal daily life, moving objects and distracting backgrounds can make vestibular exercise too uncomfortable to perform. Using these methods, the investigators aim to determine the appropriate type and amount of exercise required for symptom improvement. This study will also compare the effectiveness of performing exercises in the virtual reality environment to standard physical therapy and to healthy persons without history of vestibular disorders. Three categories of vestibular disorders will be investigated with an instrumented and usual therapy group of 1) Unilateral hypofunction, 2) bilateral hypofunction, and 3) post-concussion.

Conditions

  • Vestibular Disorder

Interventions

DEVICE

Gaze stabilization Exercises using Virtual Reality Device

Participants will utilize a wireless virtual reality headset to perform their gaze stabilization exercises to better control the background and visual field as well as collect data related to speed, excursion, and duration of head movements.

BEHAVIORAL

Gaze stabilization non-instrumented

Participants will perform gaze stabilization exercises in a non-instrumented manner. Subjects are instructed to focus on a letter on a piece of paper held at arm's length. They are instructed to move their head back and forth as quickly as they can while keeping the letter in focus. The total duration of the exercise (from 10 - 240 seconds) and background complexity (simple to complex moving) are increased gradually according to patient symptoms.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Karen Goodman, DPT · The George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2024-09-01
Completion
2024-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851184 on ClinicalTrials.gov