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Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
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.
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ClinicalTrials.gov Identifier: NCT00889824
: April 29, 2009
Results First Posted
: February 15, 2016
Last Update Posted
: February 15, 2016
Washington University School of Medicine
Barron Associates, Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.
Condition or disease
Device: balance prosthesis
This proposal addresses a National Institute on Deafness and Other communication Disorders (NIDCD) research topic that emphasizes the "development of assistive devices for balance disorders". The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.
Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. [ Time Frame: 6 weeks ]
The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.
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Ages Eligible for Study:
21 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.
Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure.
Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
Peripheral neuropathies of the lower extremities.
Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.