Back to resultsHead-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Primary Purpose
Dizziness
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
balance prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Dizziness focused on measuring Chronic imbalance, vestibular disorders, balance prosthesis
Eligibility 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prosthesis group
Arm Description
balance prosthesis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00889824
First Posted
April 27, 2009
Last Updated
January 13, 2016
Sponsor
Washington University School of Medicine
Collaborators
Barron Associates, Inc., National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00889824
Brief Title
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Official Title
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Barron Associates, Inc., National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness
Keywords
Chronic imbalance, vestibular disorders, balance prosthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prosthesis group
Arm Type
Experimental
Arm Description
balance prosthesis
Intervention Type
Device
Intervention Name(s)
balance prosthesis
Intervention Description
vibrotactile stimulation
Primary Outcome Measure Information:
Title
Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel A Goebel, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
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