Computerized Vestibular Rehabilitation

NCT03589859 | Completed Results

• 1 other identifier: C2892-P
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vestibular Diseases

Keywords

neurologic rehabilitation; computer games

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nausea Scale

  Immediately after each 10-minute game block, median value calculated for each participant

Study Arms (2)

Normal Volunteers

Testing motor learning

Diagnostic Test: VOR Test; Other: Computer Game

Vestibular hypofunction

Testing feasibility of rehabilitation game

Diagnostic Test: VOR Test; Other: Computer Game; Other: Nausea Scale

Interventions

VOR Test DIAGNOSTIC_TEST

Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.

Normal Volunteers; Vestibular hypofunction

Computer Game OTHER

Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex

Normal Volunteers; Vestibular hypofunction

Nausea Scale OTHER

Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game

Vestibular hypofunction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers and patients with vestibular hypofunction

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: NONE RETAINED

No biological specimens will be retained.

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

No conclusions can be made regarding the therapeutic efficacy of the computer game for treatment of vestibular hypofunction, because the study was not designed to test that. Instead, its objectives were, first, to test the game's ability to induce motor learning, to establish a physiological basis for therapeutic use, and, second, to test feasibility and playability by individuals with vestibular disorders.

Results Point of Contact

• Title: Dr. Mark Walker
• Organization: VA Northeast Ohio Healthcare System

mark.walker5@va.gov

216-791-3800

Study Officials

• Mark F. Walker, MD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Pursuant to Data Use Agreement
• Access Criteria: Pursuant to Data Use Agreement

Locations

US (1)