Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Dizziness Clinical Trial

Official title:

Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889824
• Other study ID #: 09-0600
• Secondary ID: 1R43DC010080-01
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2009
• Last updated: January 13, 2016
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness

Intervention

Device:
• balance prosthesis
vibrotactile stimulation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Barron Associates, Inc., National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dynamic Gait Index (DGI) From Baseline to 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.	6 weeks	No