Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Barron Associates, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00889824
First received: April 27, 2009
Last updated: March 2, 2011
Last verified: March 2011
  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
Chronic Imbalance
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

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

Primary Outcome Measures:
  • Benefit of the balance device will be defined as clinically-and statistically-significant improvement in SOT-5 and SOT-6 scores, DGI scores, ABC Scale scores, and DHI scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: February 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: balance prosthesis
    vibrotatile 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
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

Contacts
Contact: Belinda C Sinks, AuD 314-362-7546 sinksb@ent.wustl.edu
Contact: Joel A Goebel, MD 314-362-7344 goebelj@ent.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Belinda C Sinks, AuD    314-362-7546    sinksb@ent.wustl.edu   
Contact: Joel A Goebel, MD    314-362-7344    goebelj@ent.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Barron Associates, Inc.
Investigators
Principal Investigator: Joel A Goebel, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Joel A. Goebel, M.D., 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
Last Updated: March 2, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014