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Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

This study has been completed.
Sponsor:
Collaborators:
Barron Associates, Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00889824
First received: April 27, 2009
Last updated: January 13, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Dizziness
Device: balance prosthesis
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prosthesis group
balance prosthesis
Device: balance prosthesis
vibrotactile stimulation

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889824

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barron Associates, Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Joel A Goebel, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00889824     History of Changes
Other Study ID Numbers: 09-0600  1R43DC010080-01 
Study First Received: April 27, 2009
Results First Received: June 12, 2013
Last Updated: January 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Chronic imbalance
vestibular disorders
balance prosthesis

Additional relevant MeSH terms:
Dizziness
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 06, 2016