Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Phase 1

Completed

• Conditions: Dizziness
• Interventions: Device: balance prosthesis

• Registration Number: NCT00889824
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2011-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-06-12
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-13
• Last Update Submitted: 2016-01-13
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prosthesis group	balance prosthesis	balance prosthesis

Primary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States