Skip to main content
Clinical Trials/NCT00889824
NCT00889824
Completed
Phase 1

Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Washington University School of Medicine1 site in 1 country5 target enrollmentFebruary 2011
ConditionsDizziness

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Dizziness
Sponsor
Washington University School of Medicine
Enrollment
5
Locations
1
Primary Endpoint
Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
June 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials