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Computerized Vestibular Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589859
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease
Vestibular Diseases

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Computerized Game-based Vestibular Rehabilitation: Assessment of Feasibility and Motor Learning
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort
Normal Volunteers
Testing motor learning
Vestibular hypofunction
Testing feasibility of rehabilitation game



Primary Outcome Measures :
  1. Vestibulo-ocular reflex gain [ Time Frame: Immediate ]
    The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement.


Biospecimen Retention:   None Retained
No biological specimens will be retained.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal volunteers and patients with vestibular hypofunction
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589859


Contacts
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Contact: Mark F Walker, MD (216) 791-3800 ext 820 5225 Mark.Walker5@va.gov

Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mark F Walker, MD    216-791-3800 ext 820 5225    Mark.Walker5@va.gov   
Principal Investigator: Mark F. Walker, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Mark F. Walker, MD Louis Stokes VA Medical Center, Cleveland, OH
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03589859    
Other Study ID Numbers: C2892-P
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A limited set of de-identified data supporting published results will be made available on request, pursuant to a Data Use Agreement.
Time Frame: Pursuant to Data Use Agreement
Access Criteria: Pursuant to Data Use Agreement

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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
Keywords provided by VA Office of Research and Development:
neurologic rehabilitation
computer games
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases