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

April 27, 2009
March 2, 2011
February 2011
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00889824 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Imbalance
Device: balance prosthesis
vibrotatile stimulation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years to 85 Years
No
Contact: Belinda C Sinks, AuD 314-362-7546 sinksb@ent.wustl.edu
Contact: Joel A Goebel, MD 314-362-7344 goebelj@ent.wustl.edu
United States
 
NCT00889824
09-0600, 1R43DC010080-01
No
Joel A. Goebel, M.D., Washington University School of Medicine
Washington University School of Medicine
Barron Associates, Inc.
Principal Investigator: Joel A Goebel, MD Washington University School of Medicine
Washington University School of Medicine
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP