Computerized Vestibular Rehabilitation

Computerized Game-based Vestibular Rehabilitation: Assessment of Feasibility and Motor Learning

Disorders of vestibular function and balance are an important component of many conditions that commonly affect veterans, such as inner ear diseases, diabetes, and traumatic brain injury. Veterans with vestibular impairment have reduced quality of life, limitations on work and physical activities, and an increased risk of falls. The goal of this research is to develop a more engaging and effective interactive tool for vestibular rehabilitation to improve the lives of affected veterans. The first steps in this process will be to test the ability of the application to facilitate vestibular learning and to test its feasibility in vestibular patients. The hypothesis is that computer-game-based adaptation will induce robust VOR motor learning and will provide an engaging platform for vestibular rehabilitation. Ultimately, our application has the potential to provide more flexible vestibular exercises that will allow therapy to be customized for each patient. It will also have the ability to track a patient's progress over time and to advance exercises as function improves.

Study Overview

• Status: Completed
• Conditions: Vestibular Diseases
• Intervention / Treatment: Diagnostic test: VOR Test; Other: Computer Game; Other: Nausea Scale

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers and patients with vestibular hypofunction

Description

Inclusion Criteria:

• GROUP 1: Healthy volunteers: Static visual acuity of at least 20/30 at testing distance
• GROUP 2: Vestibular patients: Unilateral or bilateral vestibular hypofunction, No central vestibular disorder, Static Visual Acuity of at least 20/30 at testing distance

Exclusion Criteria:

• GROUP 1: Peripheral or central vestibular disorder
• GROUP 2: Central vestibular disorder

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Volunteers; Testing motor learning	Diagnostic test: VOR Test; Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.; Other: Computer Game; Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
Vestibular hypofunction; Testing feasibility of rehabilitation game	Diagnostic test: VOR Test; Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.; Other: Computer Game; Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex; Other: Nausea Scale; Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vestibulo-ocular Reflex Gain Ratio	The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement. The outcome measure is the ratio of the VOR gain after training to that before training. VOR gain is determined by a scaled fit of eye speed to evoking head speed (normal gain is 1). Note that this experiment was not a treatment of impairment but a test of the ability of the vestibular game to elicit motor learning (away from normal) in individuals with intact motor learning. In that context, an increase in the gain to a value greater than unity (faster eye movement relative to the head movement) is "better" with respect to the training goal, but it is not "better" with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.	VOR measurements to determine gain were performed immediately before and after each approximately 30 minute training session. Pre- and post-training gains were then combined in the VOR gain ratio to determine the training effect.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea Scale	Participants with vestibular hypofunction rated their nausea after each game block on a scale of 1 to 10. For each visit, there were up to 3 game-blocks, each of 10-minutes duration. The number of blocks was determined by the participant. A higher score is a worse outcome (more nausea). The average nausea scale rating was determined for each participant. The final result is the median of these averaged scores.	Immediately after each 10-minute game block, median value calculated for each participant

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Mark F. Walker, MD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: neurologic rehabilitation; computer games
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Labyrinth Diseases; Vestibular Diseases
• Other Study ID Numbers: C2892-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A limited set of de-identified data supporting published results will be made available on request, pursuant to a Data Use Agreement.
• IPD Sharing Time Frame: Pursuant to Data Use Agreement
• IPD Sharing Access Criteria: Pursuant to Data Use Agreement

Drug and device information, study documents

• 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